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The primary objective of this study was to compare the protection afforded by a standard face shield design with a new enhanced design in a controlled setting.This study was exempted from review by institutional review board waiver. A flexible fiberoptic endoscopy was placed through stellate openings in the standard face shield and the enhanced face shield. A series of simulated coughs were created with bursts of fluorescein dye through an atomizer tip placed within the test participant's mouth. Ultraviolet lighting illuminated the test area, and areas of dye splatter were noted.Fluorescein dye is easily aerosolized along the lateral inferior aspect of a standard shield with significant contamination of the surrounds. The enhanced face shield maintained a barrier to the aerosolized dye.Face shields, rather than face masks, should be considered a preferred alternative for the public and for health care professionals alike, as they address many of the personal protective equipment concerns especially during the COVID-19 pandemic. Otolaryngologists are at high risk from aerosol-generating procedures, such as flexible fiberoptic endoscopy, even when wearing personal protective equipment. Here we describe a uniquely designed face shield to be worn by the patient as another layer of protection for the environment and for medical personnel.During the course of a flexible fiberoptic endoscopy, medical personnel are safely isolated from potential infectious particles with a newly designed face shield.

BACKGROUND The human microbiome evolves rapidly in early life with contributions from various factors such as diet, delivery mode, medical history, antibiotics exposure, genetics, immunomodulators and the environment. A high use of antibiotics in pediatric outpatient settings has been well documented, and improvement in antibiotic selection is required to reduce the risks of antibiotic resistance and disruption of the microbiome. METHODS We performed an exploratory study using 16S rRNA gene-based sequencing to characterize the gut and nasopharyngeal microbiome of children (n = 50) age 1-6 years of age in a pediatric otolaryngology practice. RESULTS Relative abundance of Haemophilus and Moraxella were higher in nasopharyngeal swabs, while Prevotella, Bacteroides, Porphyromonas and Faecalibacterium were highly abundant in rectal swabs. The gut microbiome composition in children

PURPOSE OF REVIEW Pediatric cough is a common complaint in 35% of preschool children and 9% of 7-11-year-olds. The cause of the cough is often elusive. This review article presents a framework from which to approach the pediatric patient with chronic cough. RECENT FINDINGS The cause of cough in the pediatric patient is often allergy, postnasal drip, asthma, or infection. The existence of cough-variant asthma has been brought into question and evidence is detailed in this article. SUMMARY The treatment of chronic cough in a pediatric population should be approached from a multidisciplinary team consisting of pulmonologists, gastroenterologists, allergists, immunologists and otolaryngologists. Once a specific diagnosis is determined, treatment should be specific to that diagnosis.

It is estimated that >24 million cases of acute bacterial sinusitis occur annually in the United States. Recently, a number of medical societies have issued guidelines to aid in the management of upper respiratory tract infections (URIs). Although these guidelines serve to aid practitioners in the proper use of antibiotics, confusion remains regarding the disparity of guideline recommendations as well as some recommendations being outdated. This review presents 3 illustrative case studies designed to provide some clarity with regard to these guidelines. Case 1 is a typical presentation of a patient with worsening sinus conditions over the previous 2 weeks. Case 2 is a more challenging case of a patient with a sinus condition accompanied by a penicillin allergy that ultimately requires referral to an otolaryngologist. Case 3 is an atypical case with symptoms of a sinus infection accompanied by a normal sinus computed tomography scan. It is hoped that the presentation and discussion surrounding these cases will provide some helpful insights into the management of patients with URIs.

Objectives/Hypothesis: Although many proinflammatory cytokines have been identified in nasal polyp tissue, the initial trigger that causes this inflammation characterized by edema, lymphocytosis, and eosinophilia, is still unknown. The purpose of the present study is to identify the presence of genetic polymorphisms in proinflammatory, anti-inflammatory, and chemokine genes that might contribute to genetic susceptibility to chronic hyperplastic sinusitis with nasal polyposis (CHSwNP). Study Design: Case control study. Methods: Buccal swabs were taken from the left and right oral mucosal surfaces from 179 patients with CHSwNP and 153 nonpolyposis controls with the Purgene DNA purification protocol (Gentra). Genotyping assays for cytokine gene loci were performed on 14 cytokine genes using the iPlex Gold and the Mass Array Compact system (Sequenom, San Diego, CA). Tests of Hardy-Weinberg equilibrium proportions were performed separately in the cases and controls. Tests for evidence of association between alleles at each single-nucleotide polymorphism (SNP) and casecontrol status were performed using unconditional logistic regression. Results: The frequency of the A allele in a SNP located in tumor necrosis factor (TNF)-a (rs1800629) is significantly different in patients with nasal polyposis versus controls without nasal polyposis, 18.6% and 11.5%, respectively with an individuals’ odds of susceptibility to nasal polyps increasing almost twofold (odds ratio, 1.86; confidence interval, 1.4–3.09) given at least one copy of the A allele at this SNP. All other cytokine gene polymorphisms of both inflammatory, anti-inflammatory, and chemokine genes were not statistically different between the two groups. Conclusions: TNF-a-308, a SNP in the promoter region of this cytokine gene is associated with increased odds of developing nasal polyposis. TNF-a is a potent immuno-mediator and proinflammatory cytokine that has been implicated in the pathogenesis of a large number of human diseases. The location of this gene on the short arm of chromosome 6, with the major histocompatibility complex genes and complement, has raised the probability that polymorphism within this locus may contribute to a genetic association of this region of the genome with a wide variety of infectious and autoimmune diseases.

Purpose Acute bacterial rhinosinusitis (ABRS) is a common and uncomfortable condition, frequently caused by Streptococcus pneumoniae or Haemophilus influenzae. Antibacterial resistance among these and other common respiratory pathogens is now widespread and of concern. Pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg was developed to be effective against the common respiratory pathogens, including many resistant strains. Materials and methods This open-label, noncomparative study assessed the bacteriologic and clinical efficacy of amoxicillin/clavulanate 2000/125 mg in adult patients with ABRS. Requirements for study entry included a clinical diagnosis of ABRS supported by radiologic findings. In addition, sinus puncture for bacteriologic assessment was required at study entry. Results Overall, bacteriologic success (eradication or clinical evidence of eradication) at the follow-up visit (days 17–28) was achieved in 87.8% (722/822) of patients with 1 or more pathogen isolated at screening, in 93.2% (246/264) of patients with S pneumoniae, in 96.7% (29/30) of those with penicillin-resistant S pneumoniae (penicillin minimum inhibitory concentrations ≥2 μg/mL), and in 88.7% (110/124) of patients with β-lactamase–positive pathogens. Bacteriologic success was achieved against 6 of 7 S pneumoniae isolates with amoxicillin/clavulanic acid minimum inhibitory concentrations of 4/2 μg/mL or higher. Conclusions Amoxicillin/clavulanate 2000/125 mg was generally well tolerated. This new amoxicillin/clavulanate formulation provides a suitable option for empiric therapy for ABRS in adults.

Acute bacterial rhinosinusitis (ABRS) is a secondary bacterial infection of the nose and paranasal sinuses, usually preceded by a viral upper respiratory infection or allergy, with symptoms that have not improved after 10 days or that have worsened after 5 to 7 days. Streptococcus pneumoniae and Haemophilus influenzae are the most common causes of ABRS in adults. Increasing rates of antimicrobial resistance among S. pneumoniae and beta-lactamase production among H. influenzae are formidable challenges to the successful treatment of infections caused by these organisms. To this end, various formulations of amoxicillin-clavulanate have been developed, the most recent of which is pharmacokinetically enhanced and provides a total daily dose of 4,000 mg of amoxicillin and 250 mg of clavulanate. This formulation has been shown to be safe and effective in the treatment of infections caused by penicillin-resistant S. pneumoniae (minimum inhibitory concentration 2 microg/mL); the clavulanate component provides adequate coverage of beta-lactamase-producing pathogens.

The pharmacologic field that studies antimicrobial pharmacokinetics and pharmacodynamics (PK/PD) has had a major impact on the choice and dosing regimens used for many antibiotics especially those used in the treatment of respiratory tract infections. PK/PD parameters are particularly important in light of increasing antimicrobial resistance. Drug pharmacokinetic features, such as serum concentrations over time and area under the concentration-time curve, when integrated with minimum inhibitory concentration (MIC) values of antibiotics against pathogens, can predict the probability of bacterial eradication and clinical success. These pharmacokinetic and pharmacodynamic relationships also are important in preventing the selection and spread of resistant strains and have led to the description of the mutation prevention concentration, which is the lowest concentration of antimicrobial that prevents selection of resistant bacteria from high bacterial inocula. b-lactams are time-dependent agents without significant post-antibiotic effects, resulting in bacterial eradication when unbound serum concentrations exceed MICs of these agents against infecting pathogens for >40% to 50% of the dosing interval. Macrolides, azaolides, and lincosamides are time-dependent agents with prolonged post-antibiotic effects, and fluoroquinolones are concentration-dependent agents, resulting in both cases in bacterial eradication when unbound serum area-under-the-curve to MIC ratios exceed 25 to 30. These observations have led to changes in recommended antimicrobial dosing against respiratory pathogens and are used to assess the role of current agents, develop new formulations, and assess potency of new antimicrobials.

Antimicrobial resistance among respiratory tract pathogens represents a significant health care threat. Identifying the antimicrobial agents that remain effective in the presence of resistance, and knowing why, requires a thorough understanding of the mechanisms of action of the various agents as well as the mechanisms of resistance demonstrated among respiratory tract pathogens. The primary goal of antimicrobial therapy is to eradicate the pathogen, via killing or inhibiting bacteria, from the site of infection; the defenses of the body are required for killing any remaining bacteria. Targeting a cellular process or function specific to bacteria and not to the host limits the toxicity to patients. Currently, there are four general cellular targets to which antimicrobials are targeted: cell wall formation and maintenance, protein synthesis, DNA replication, and folic acid metabolism. Resistance mechanisms among respiratory tract pathogens have been demonstrated for all four targets. In general, the mechanisms of resistance used by these pathogens fall into one of three categories: enzymatic inactivation of the antimicrobial, prevention of intracellular accumulation, and modification of the target site to which agents bind to exert an antimicrobial effect. Resistance to some agents can be overcome by modifying the dosage regimens (e.g., using high-dose therapy) or inhibiting the resistance mechanism (e.g., b-lactamase inhibitors), whereas other mechanisms of resistance can only be overcome by using an agent from a different class. Understanding the mechanisms of action of the various agents and the mechanisms of resistance used by respiratory tract pathogens can help clinicians identify the agents that will increase the likelihood of achieving optimal outcomes.

Treatment guidelines developed by the Sinus and Allergy Health Partnership for acute bacterial rhinosinusitis (ABRS) were originally published in 2000. These guidelines were designed to: (1) educate clinicians and patients (or patients’ families) about the differences between viral and bacterial rhinosinusitis; (2) reduce the use of antibiotics for nonbacterial nasal/sinus disease; (3) provide recommendations for the diagnosis and optimal treatment of ABRS; (4) promote the use of appropriate antibiotic therapy when bacterial infection is likely; and (5) describe the current understanding of pharmacokinetic and pharmacodynamics and how they relate to the effectiveness of antimicrobial therapy. The original guidelines are updated here to include the most recent information on management principles, antimicrobial susceptibility patterns, and therapeutic options. Burden of disease An estimated 20 million cases of ABRS occur annually in the United States. According to National Ambulatory Medical Care Survey (NAMCS) data, sinusitis is the fifth most common diagnosis for which an antibiotic is prescribed. Sinusitis accounted for 9% and 21% of all pediatric and adult antibiotic prescriptions, respectively, written in 2002. The primary diagnosis of sinusitis results in expenditures of approximately $3.5 billion per year in the United States. Definition and diagnosis of ABRS ABRS is most often preceded by a viral upper respiratory tract infection (URI). Allergy, trauma, dental infection, or other factors that lead to inflammation of the nose and paranasal sinuses may also predispose individuals to developing ABRS. Patients with a “common cold” (viral URI) usually report some combination of the following symptoms: sneezing, rhinorrhea, nasal congestion, hyposmia/anosmia, facial pressure, postnasal drip, sore throat, cough, ear fullness, fever, and myalgia. A change in the color or the characteristic of the nasal discharge is not a specific sign of a bacterial infection. Bacterial superinfection may occur at any time during the course of a viral URI. The risk that bacterial superinfection has occurred is greater if the illness is still present after 10 days. Because there may be cases that fall out of the “norm” of this typical progression, practicing clinicians need to rely on their clinical judgment when using these guidelines. In general, however, a diagnosis of ABRS may be made in adults or children with symptoms of a viral URI that have not improved after 10 days or worsen after 5 to 7 days. There may be some or all of the following signs and symptoms: nasal drainage, nasal congestion, facial pressure/pain (especially when unilateral and focused in the region of a particular sinus), postnasal drainage, hyposmia/anosmia, fever, cough, fatigue, maxillary dental pain, and ear pressure/fullness. Physical examination provides limited information in the diagnosis of ABRS. While sometimes helpful, plain film radiographs, computed tomography (CT), and magnetic resonance imaging scans are not necessary for cases of ABRS. Microbiology of ABRS The most common bacterial species isolated from the maxillary sinuses of patients with ABRS are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, the latter being more common in children. Other streptococcal species, anaerobic bacteria and Staphylococcus aureus cause a small percentage of cases. Bacterial resistance in ABRS The increasing prevalence of penicillin nonsusceptibility and resistance to other drug classes among S pneumoniae has been a problem in the United States, with 15% being penicillin-intermediate and 25% being penicillin-resistant in recent studies. Resistance to macrolides and trimethoprim/sulfamethoxazole (TMP/SMX) is also common in S pneumoniae. The prevalence of β-lactamase-producing isolates of H influenzae is approximately 30%, while essentially all M catarrhalis isolates produce β-lactamases. Resistance of H influenzae to TMP/SMX is also common. Antimicrobial treatment guidelines for ABRS These guidelines apply to both adults and children. When selecting antibiotic therapy for ABRS, the clinician should consider the severity of the disease, the rate of progression of the disease, and recent antibiotic exposure. The guidelines now divide patients with ABRS into two general categories: (1) those with mild symptoms who have not received antibiotics within the past 4 to 6 weeks, and (2) those with mild disease who have received antibiotics within the past 4 to 6 weeks or those with moderate disease regardless of recent antibiotic exposure. The difference in severity of disease does not imply infection with a resistant pathogen. Rather, this terminology indicates the relative degree of acceptance of possible treatment failure and the likelihood of spontaneous resolution of symptoms—patients with more severe symptoms are less likely to resolve their disease spontaneously. The primary goal of antibiotic therapy is to eradicate bacteria from the site of infection, which, in turn, helps (1) return the sinuses back to health; (2) decrease the duration of symptoms to allow patients to resume daily activities more quickly; (3) prevent severe complications such as meningitis and brain abscess; and (4) decrease the development of chronic disease. Severe or life-threatening infections with or without complications are rare, and are not addressed in these guidelines. Prior antibiotic use is a major risk factor associated with the development of infection with antimicrobial-resistant strains. Because recent antimicrobial exposure increases the risk of carriage of and infection due to resistant organisms, antimicrobial therapy should be based upon the patient’s history of recent antibiotic use. The panel’s guidelines, therefore, stratify patients according to antibiotic exposure in the previous 4 to 6 weeks. Lack of response to therapy at ≥72 hours is an arbitrary time established to define treatment failures. Clinicians should monitor the response to antibiotic therapy, which may include instructing the patient to call the office or clinic if symptoms persist or worsen over the next few days. The predicted bacteriologic and clinical efficacy of antibiotics in adults and children has been determined according to mathematical modeling of ABRS developed by Michael Poole, MD, PhD, based on pathogen distribution, resolution rates without treatment, and in vitro microbiologic activity. Antibiotics can be placed into the following relative rank order of predicted clinical efficacy for adults: 90% to 92% = respiratory fluoroquinolones (gatifloxacin, levofloxacin, moxifloxacin), ceftriaxone, high-dose amoxicillin/clavulanate (4 g/250 mg/day), and amoxicillin/clavulanate (1.75 g/250 mg/day); 83% to 88% = high-dose amoxicillin (4 g/day), amoxicillin (1.5 g/day), cefpodoxime proxetil, cefixime (based on H influenzae and M catarrhalis coverage), cefuroxime axetil, cefdinir, and TMP/SMX; 77% to 81% = doxycycline, clindamycin (based on gram-positive coverage only), azithromycin, clarithromycin and erythromycin, and telithromycin; 65% to 66% = cefaclor and loracarbef. The predicted spontaneous resolution rate in patients with a clinical diagnosis of ABRS is 62%. Antibiotics can be placed into the following relative rank order of predicted clinical efficacy in children with ABRS: 91% to 92% = ceftriaxone, high-dose amoxicillin/clavulanate (90 mg/6.4 mg per kg per day) and amoxicillin/clavulanate (45 mg/6.4 mg per kg per day); 82% to 87% = high-dose amoxicillin (90 mg/kg per day), amoxicillin (45 mg/kg per day), cefpodoxime proxetil, cefixime (based on H influenzae and M catarrhalis coverage only), cefuroxime axetil, cefdinir, and TMP/SMX; and 78% to 80% = clindamycin (based on gram-positive coverage only), cefprozil, azithromycin, clarithromycin, and erythromycin; 67% to 68% = cefaclor and loracarbef. The predicted spontaneous resolution rate in untreated children with a presumed diagnosis of ABRS is 63%. Recommendations for initial therapy for adult patients with mild disease (who have not received antibiotics in the previous 4 to 6 weeks) include the following choices: amoxicillin/clavulanate (1.75 to 4 g/250 mg per day), amoxicillin (1.5 to 4 g/day), cefpodoxime proxetil, cefuroxime axetil, or cefdinir. While TMP/SMX, doxycycline, azithromycin, clarithromycin, erythromycin, or telithromycin may be considered for patients with β-lactam allergies, bacteriologic failure rates of 20% to 25% are possible. Failure to respond to antimicrobial therapy after 72 hours should prompt either a switch to alternate antimicrobial therapy or reevaluation of the patient (see Table 4).When a change in antibiotic therapy is made, the clinician should consider the limitations in coverage of the initial agent. Recommendations for initial therapy for adults with mild disease who have received antibiotics in the previous 4 to 6 weeks or adults with moderate disease include the following choices: respiratory fluoroquinolone (eg, gatifloxacin, levofloxacin, moxifloxacin) or high-dose amoxicillin/clavulanate (4 g/250 mg per day). The widespread use of respiratory fluoroquinolones for patients with milder disease may promote resistance of a wide spectrum of organisms to this class of agents. Ceftriaxone (parenteral, 1 to 2 g/day for 5 days) or combination therapy with adequate gram-positive and negative coverage may also be considered. Examples of appropriate regimens of combination therapy include high-dose amoxicillin or clindamycin plus cefixime, or high-dose amoxicillin or clindamycin plus rifampin. While the clinical effectiveness of ceftriaxone and these combinations for ABRS is unproven; the panel considers these reasonable therapeutic options based on the spectrum of activity of these agents and on data extrapolated from acute otitis media studies. Rifampin should not be used as monotherapy, casually, or for longer than 10 to 14 days, as resistance quickly develops to this agent. Rifampin is also a well-known inducer of several cytochrome p450 isoenzymes and therefore has a high potential for drug interactions. Failure of a patient to respond to antimicrobial therapy after 72 hours of therapy should prompt either a switch to alternate antimicrobial therapy or reevaluation of the patient (see Table 4). When a change in antibiotic therapy is made, the clinician should consider the limitations in coverage of the initial agent. Patients who have received effective antibiotic therapy and continue to be symptomatic may need further evaluation. A CT scan, fiberoptic endoscopy or sinus aspiration and culture may be necessary. Recommendations for initial therapy for children with mild disease and who have not received antibiotics in the previous 4 to 6 weeks include the following: high-dose amoxicillin/clavulanate (90 mg/6.4 mg per kg per day), amoxicillin (90 mg/kg per day), cefpodoxime proxetil, cefuroxime axetil, or cefdinir. TMP/SMX, azithromycin, clarithromycin, or erythromycin is recommended if the patient has a history of immediate Type I hypersensitivity reaction to β-lactams. These antibiotics have limited effectiveness against the major pathogens of ABRS and bacterial failure of 20% to 25% is possible. The clinician should differentiate an immediate hypersensitivity reaction from other less dangerous side effects. Children with immediate hypersensitivity reactions to β-lactams may need: desensitization, sinus cultures, or other ancillary procedures and studies. Children with other types of reactions and side effects may tolerate one specific β-lactam, but not another. Failure to respond to antimicrobial therapy after 72 hours should prompt either a switch to alternate antimicrobial therapy or reevaluation of the patient (see Table 5).When a change in antibiotic therapy is made, the clinician should consider the limitations in coverage of the initial agent. The recommended initial therapy for children with mild disease who have received antibiotics in the previous 4 to 6 weeks or children with moderate disease is high-dose amoxicillin/clavulanate (90 mg/6.4 mg per kg per day). Cefpodoxime proxetil, cefuroxime axetil, or cefdinir may be used if there is a penicillin allergy (eg, penicillin rash); in such instances, cefdinir is preferred because of high patient acceptance. TMP/SMX, azithromycin, clarithromycin, or erythromycin is recommended if the patient is β-lactam allergic, but these do not provide optimal coverage. Clindamycin is appropriate if S pneumoniae is identified as a pathogen. Ceftriaxone (parenteral, 50 mg/kg per day for 5 days) or combination therapy with adequate gram-positive and -negative coverage may also be considered. Examples of appropriate regimens of combination therapy include high-dose amoxicillin or clindamycin plus cefixime, or high-dose amoxicillin or clindamycin plus rifampin. The clinical effectiveness of ceftriaxone and these combinations for ABRS is unproven; the panel considers these reasonable therapeutic options based on spectrum of activity and on data extrapolated from acute otitis media studies. Rifampin should not be used as monotherapy, casually, or for longer than 10 to 14 days as resistance quickly develops to this agent. Failure to respond to antimicrobial therapy after 72 hours of therapy should prompt either a switch to alternate antimicrobial therapy or reevaluation of the patient (see Table 5). When a change in antibiotic therapy is made, the clinician should consider the limitations in coverage of the initial agent. Patients who have received effective antibiotic therapy and continue to be symptomatic may need further evaluation. A CT scan, fiberoptic endoscopy or sinus aspiration and culture may be necessary.

Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients. Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged ≥6 months to 12 years with an AOMT episode of ≤3 weeks’ duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%). Results. Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen. Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT.

OBJECTIVE: The primary objective of this study was to demonstrate the clinical and radiologic efficacy of 5 days compared with 7 days of gemifloxacin therapy in the treatment of acute bacterial rhinosinusitis (ABRS).STUDY DESIGN: In this prospective, double-blind, multicenter, parallel-group study, adult patients presenting with ABRS were randomized to receive gemifloxacin 320 mg once daily for either 5 days (n = 218) or 7 days (n = 203).RESULTS: For the primary efficacy end point, clinical response to therapy at follow-up, 5 days of therapy with gemifloxacin was as effective as 7 days of therapy (per-protocol population; treatment difference 0.44%; 95% confidence interval (CI), −6.54 to 7.41). Five and 7 days of treatment with gemifloxacin were well tolerated.CONCLUSION AND SIGNIFICANCE: The clinical efficacy of gemifloxacin 320 mg daily for 5 days is at least as good as the efficacy of gemifloxacin 320 mg daily for 7 days in the treatment of ABRS.

This study assessed daily aspirate samples from an indwelling sinus catheter during high-dose, short-course levofloxacin (750 mg daily x 5 days) treatment of acute maxillary sinusitis. Pathogens were isolated from 4 of 18 recruited patients. Bacteriologic eradication occurred within 24 h for 3 patients and 72 h for the 4th.

Objectives : To examine four different types of computer-aided endoscopic sinus surgical devices-the ISG Viewing Wand, the ISG infrared OptoTrak, the IGT FlashPoint 5000, and the VTI InstaTrak-with emphasis on their accuracy and ease of use. Study Design : Prospective study utilizing laboratory experiments and intraoperative data collection. Methods: A review of the literature is presented. Patients undergoing endoscopic sinus surgery during the study period were enlisted under FDA protocols with IRB consent. Groups of patients had surgery performed with each of the above devices-except the FlashPoint 5000. Accuracy measurements were recorded, and user and operating staff comments about ease of use were collected. The FlashPoint 5000 was used exclusively in the laboratory setting, where accuracy measurements were obtained on a cadaver skull. Results: The systems all demonstrated accuracy to within 2.00 mm. Ease of use was somewhat variable, but following a learning curve by the surgeon and operating department personnel, all of the units were considered to be relatively user friendly. Conclusions: Computer-aided endoscopic sinus surgery appears to be the wave of the future. Nevertheless, the modern endoscopic sinus surgeon must have thorough training in the basic anatomy of the paranasal sinuses as well as the various surgical techniques.

This is a review of the innervation of the midface and nose as a guide to anesthesia in this region. Through an understanding of the embryologic development, better predictions of nerve coverage are possible. The variables encountered during surgery can be appreciated, and in a practical sense this leads to anesthetic approaches that allow comfortable and controlled surgery in this area.

Hereditary angioedema (HAE) is a relatively rare genetic disorder that is usually characterized by either low levels of C1 esterase inhibitor (C1-INH) or the presence of dysfunctional C1-INH. It can present with relatively mild and self-limiting symptoms, but it is also potentially fatal; the most common cause of death is asphyxiation secondary to edema of the upper airway. The diagnosis of HAE, especially in the emergency situation, is not straightforward. HAE must be distinguished from several other types of angioedema that require different management approaches. Management approaches include trigger avoidance and pharmacologic therapy; the latter has traditionally involved the administration of attenuated androgens and antifibrinolytics. Recently, a new class of agent-C1-INH-has been introduced in the United States. This article provides an update on the pathophysiology, clinical picture, diagnosis, prophylaxis, and acute treatment of HAE. We must keep HAE in mind as a possible diagnosis whenever we are faced with a case of unexplained angioedema if we are to take advantage of the effective and more specific therapies that are becoming available.

Sinusitis remains 1 of the most common reasons for antimicrobial prescriptions in the United States, with health care costs approaching $4 billion annually. We utilized the serial sinus aspirate sampling (SSAS) technique to obtain daily specimens to evaluate the time course of drug effect in patients with acute maxillary sinusitis. Eighteen patients with a radiologically confirmed acute maxillary sinusitis were enrolled into a study evaluating the relationship between levofloxacin exposure and the time course of antimicrobial effect using SSAS. SSAS was performed daily during therapy for bacteriologic evaluation. Six steady-state levofloxacin concentrations were obtained. Levofloxacin plasma and sinus aspirate concentrations were modeled using Monte Carlo Parametric Expectation Maximization algorithm implemented in S-ADAPT 1.53. Endpoints evaluated included time to resolution of signs and symptoms and time to sinus sterilization. Among the 18 enrolled patients, 15 were clinically evaluable. From these, 1 Streptococcus pneumoniae , 3 Haemophilus influenzae , 1 Moraxella catarrhalis , 1 Corynebacterium spp., and 1 coagulase-negative Staphylococcus organisms were isolated, with the latter 2 organisms being likely contaminants. For the pathogens, levofloxacin MIC values ranged from 0.03 to 2 mg/L. All pathogens were eradicated by the 4th day of therapy. The median and mean time to sinus sterilization (pathogens only) was 1 and 1.4 days, respectively. The median time to resolution of each sign and symptom ranged from 1.5 to 12–19 days, with the 83% of total signs and symptoms resolved by the end of therapy (day 5). The mean plasma area under the concentration-time curve (AUC) (mg ∙ h/L) was 100.1 ( n = 14, %CV = 27). Plasma AUC/MIC ratios ranged from 33.9 to 1696 for isolated pathogens. In this pilot SSAS study, levofloxacin rapidly eradicated isolated pathogens from the maxillary sinus.

We evaluated the efficacy of a new pharmacokinetically enhanced formulation of amoxicillin/clavulanate (2,000/125 mg) twice daily for the treatment of acute bacterial rhinosinusitis (ABRS) caused by Streptococcus pneumoniae, particularly penicillin-resistant S pneumoniae (PRSP; penicillin minimum inhibitory concentrations [MICs]:or = 2 microg/ml. A total of 2,482 patients received study medication (safety population). Of these, 2,324 were clinically evaluable (efficacy population), and 1,156 of them had at least one pathogen isolated at screening (bacteriology population). S pneumoniae was isolated from 371 patients in the bacteriology population, including 37 with PRSP. Follow-up in the bacteriology population on days 17 through 28 revealed that amoxicillin/clavulanate therapy was successful in 345 of 371 patients with S pneumoniae infection (93.0%) and in 36 of 37patients with PRSP infection (97.3%), including 7 of 8 patients (87.5%) whose amoxicillin/clavulanic acid MICs were 4/2 microg/ml or higher. Pharmacokinetically enhanced amoxicillin/clavulanate was generally well tolerated, as only 2.2% of patients withdrew because of adverse events. This agent represents a valuable new therapeutic option for the empiric treatment of ABRS, particularly in areas where antimicrobial-resistant pathogens (including beta-lactamase-positive organisms) are prevalent, and for the treatment of patients who are at increased risk of infection with PRSP.

Objective Compare two dosage strengths of levofloxacin in the treatment of acute bacterial sinusitis. Study design and setting Multicenter clinical trial comparing levofloxacin 750 mg for 5 days vs levofloxacin 500 mg for 10 days. Results Sinus fluid samples were obtained by antral puncture (59.2%) or by sinus endoscopy (40.8%). Among microbiologically evaluable patients, 91.4% (139/152) of patients receiving levofloxacin 750 mg achieved clinical success vs 88.6% (132/149) of patients receiving levofloxacin 500 mg (95% CI -10.0, 4.2). Clinical success rates by pathogen were above 90% in both treatment groups for the 3 typical pathogens of acute sinusitis: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The safety profile of the 2 dosage strengths was similar. Conclusion Levofloxacin 750 mg for 5 days is noninferior to levofloxacin 500 mg for 10 days. Significance Levofloxacin 750 mg for 5 days represents a safe and effective treatment regimen for acute bacterial sinusitis. Ebm rating A-1b.

Episodes of acute rhinosinusitis are common among adults and are associated with a significant amount of morbidity. The symptoms of rhinosinusitis are nasal drainage, congestion, and sinus pressure. A bacterial sinus infection is more likely if these symptoms worsen after 5–7 days or do not improve after 10–14 days. The majority of bacterial episodes have been associated with Streptococcus pneumoniae and Haemophilus influenzae. In the current era of increasing resistance to β-lactams and macrolides, treatment guidelines have been formulated worldwide to assist clinicians in the selection of antibacterials. According to one model, the following antibacterials are most likely to provide desired outcomes (90%–92% predicted clinical efficacy) for adults: respiratory fluoroquinolones (i.e., moxifloxacin, gatifloxacin, and levofloxacin), ceftriaxone, and high-dose amoxicillin-clavulanate (4 g of amoxicillin/day and 250 mg of clavulanate/day). Although the role of the fluoroquinolones in the treatment of this condition is evolving, fluoroquinolones are often recommended as second-line therapy or as first-line therapy for selected patients (e.g., those who received antibacterials in the previous 4–6 weeks or adults with moderate-to-severe disease).

The relationship between drug exposure and the time course of antimicrobial effect at the primary infection site for acute maxillary sinusitis has not previously been explored. This single-center, open-label study quantified the time course of sinus sterilization, described gatifloxacin exposure at the infection site, and posed the hypothesis that the use of continuous and quantitative time-related end points may allow for better characterization of drug effect with fewer patients than traditional clinical trial approaches. Of the 12 enrolled patients, 10 were clinically evaluable, from whom 7 pathogens were isolated: 4 Streptococcus pneumoniae, 2 staphylococci, and 1 Enterobacter aerogenes. The median predicted 24-h area under the curve (AUC) in sinus aspirates and plasma samples was 54.7 mg × h/L and 30.1 mg × h/L, respectively. The median 24-h AUC ratio for sinus aspirates and plasma samples was 1.51 (range, 0.88–2.23). For patients infected with pneumococci, the median time to sinus sterilization was 50 h. The use of quantitative time-related end points may be useful in evaluating the efficacy of antimicrobial agents with fewer patients.

Chronic rhinosinusitis Chronic rhinosinusitis (CRS) is a term that has been used to describe a number of entities characterized by chronic symptoms of nasal and sinus inflammation or infection. There has been a lack of consensus regarding definitions and treatments because CRS may be a spectrum of diseases with a range of appropriate treatments. The absence of widely accepted definitions for CRS has resulted in a paucity of research directed at understanding its pathophysiology and has hampered efforts to improve treatment. A Task Force was convened by the Sinus and Allergy Health Partnership to summarize much of the current and important information available regarding the prevalence, economic impact, pathophysiology, common inflammatory mediators, and the role of infectious microbes such as bacteria and fungi in CRS. The goal is to establish a standard and usable definition. Through this thorough review of the literature and the expert input from Task Force members, a definition was developed that serves to create a consistent baseline so that many of the currently debated or unanswered questions may be addressed. The new and more-specific Task Force definition is that “ Chronic rhinosinusitis is a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 weeks duration.” Recommended criteria for making the diagnosis of CRS for both clinical care and research were also outlined.

Acute rhinosinusitis represents a condition for which educational efforts could help minimize the inappropriate use of antibiotics, particularly for children. The majority of acute rhinosinusitis cases are of viral etiology and thus, are self limiting. Although bacterial infection complicates a small number of cases, the lack of accessibility to the sinus, the limitations of diagnostic modalities and the lack of specificity among signs and symptoms often make it difficult to determine when bacterial infection occurs. Furthermore, antimicrobial resistance among the pathogens that frequently cause bacterial infection complicates the election of empiric therapy. The Sinus and Allergy Health Partnership recently developed and published antimicrobial guidelines to provide practitioners in the US with recommendations for the diagnosis and treatment of acute bacterial rhinosinusitis. The purpose of this paper is to review the rationale behind the development of these guidelines and how they apply to the management of acute bacterial rhinosinusitis in children.

This study addresses the bacterial flora of chronic rhinosinusitis at the time of endoscopic sinus surgery. We used the consensus definition of chronic rhinosinusitis as the presence of paranasal sinus inflammation present for greater than 12 weeks. In our patient study group, all cases of chronic rhinosinusitis had failed to respond to antibiotic therapy and had not been treated previously with surgery. By microscopic examination, chronic inflammatory changes were confirmed in the resected sinus lining of all study patients. Intraoperative cultures were obtained from the nasal vestibule, the middle meatus, ethmoid lining, and peripheral blood during and after the endoscopic procedure. We found approximately 30% of the patients with sterile sinuses, 50% with coagulase-negative staphylococci, and the remainder with a mixed group of “nonpathogenic” organisms. Anaerobes were conspicuously rare. The blood cultures were positive in 7% of cases and were consistent with an organism of the operative site. This is the first time bacteremia has been reported in association with endoscopic sinus surgery. The results suggest that chronic rhinosinusitis is not a bacterial disease, but rather the result of chronic inflammation produced by a previous acute inflammation. The incidence of positive blood cultures, while relatively low and cleared quickly, should alert the physician for the possible need for prophylactic antibiotics in patients with cardiac, prosthetic, or systemic conditions that could lead to metastatic infection.

A 10-kg 9-month-old infant with recurrent, unresponsive otitis media presented with bilateral acute otitis media caused by Streptococcus pneumoniae type 19A, resistant to all oral agents and intermediately susceptible to ceftriaxone. Treatment with myringotomies and intramuscular ceftriaxone, 50 mg/kg/d for 5 days, was unsuccessful. The patient responded to pressure equalization tubes and local ciprofloxacin with dexamethasone drops.

The management of rhinosinusitis depends on a number of variables related to the duration and severity of symptoms in the individual patient. Furthermore acute rhinosinusitis is managed differently than chronic rhinosinusitis. Because a variety of conservative and pharmacologic interventions are available, the physician can find it difficult to develop a cohesive and logical approach to treatment. An understanding of the pathophysiology, microbiology, and natural history of rhinosinusitis is necessary to formulate the best treatment plan for the individual patient.

To the Editor.—Parotidectomy with preservation of the facial nerve is a procedure commonly performed by many otolaryngologists. While there are a variety of techniques for performing a parotidectomy, the techniques to monitor the facial nerve during this surgery have received little emphasis. Since 1988, we have been using a specific nerve monitor (Nerve Integrity Monitor II ([NIM II], Xomed, Jacksonville, Fla) to intraoperatively monitor facial muscle electromyographic signals via needle electrodes placed within specific muscles of the face. The patient is prepared and draped in the usual fashion for parotidectomy. Once the sterile field is established, the needle electrodes are placed into the orbicularis oculi muscles as well as in the region of the orbicularis oris muscle. This takes only a few minutes to do. Ground electrodes are also placed. Once a baseline electromyogram is obtained, any muscle stimulus will subsequently be displayed on the viewing screen as a