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Antibiotics represent a powerful weapon against infections. As dentists we are faced almost on a daily basis with the need to prescribe antibiotics. At the same time, we can often see that the antibiotics use tends to get out of control or that they are used indiscriminately with no real need. The aim of this case study is to investigate the effectiveness of amoxicillin and clavulanic acid combination in various dental ailments but also to demonstrate possible difference in the severity of symptoms after the use of amoxicillin and antibiotic combination of amoxicillin and clavulanic acid after surgical and oral interventions. The investigation involved 102 patients who were divided into two groups (the first group consisting of 59 and the second one of 43 patients). Following surgical treatment the first group of patients was prescribed antibiotic combination of amoxicillin and clavulanic acid in the dosage of 625 mg, 3 times per day. The second group of 43 patients was prescribed amoxicillin in the dosage of 500 mg, 4 times per day. The recommended therapy for antibiotic combination of amoxicillin and clavulanic acid was 5 to 10 days after the operation and 8 to 10 days for amoxicillin. In other words, both groups of patients started to use antibiotics after the surgical or oral intervention such as operative removal of impacted wisdom teeth, apicoectomy or complicated extractions, and also after the treatment of odontogenic abscesses etc. The same parameters were measured prior to the surgical intervention in cases when patients demonstrated the symptoms before the operational treatment while in all other cases the parameters were measured 48 hours and seven days following the operation. The measured parameters were: pain, swelling, body temperature, dysfunction such as dysphagus trismus, chewing disorder and possible allergic or gastrointestinal reactions. All parameters observed were precisely set in order to harmonize the investigation criteria and facilitate statistical data processing. With respect to pain before the operation there was no substantial statistical difference, p>0.05 (t=0.56; t=0.69). With respect to the onset of pain and the use of antibiotics after 48 hours there is a significant difference in favor of antibiotic combination of amoxicillin and clavulanic acid (X= 14.83, p= 0.002; p <0.01). Thus, pain is less acute if antibiotic combination of amoxicillin and clavulanic acid is administered. With respect to swelling and administration of antibiotics 48 hours after the operation there is no significant difference between the use of the two antibiotic therapies (X= 4.89; p=0.18; p>0.05). The investigation conducted seven days after the operation with regard to pain and the use of either antibiotic therapies demonstrated significant statistical difference (X=9.35, p<0.01) in favor of antibiotic combination of amoxicillin and clavulanic acid. In other words, patients who used amoxicillin and clavulanic acid felt significantly less intense pain. With respect to swelling, significant statistical difference between the two groups of patients was established in favor of antibiotic combination of amoxicillin and clavulanic acid, i.e. p<0.05 (X=6.45, p=0.03). The combination of amoxicillin and clavulanic has proven to be significantly more effective in comparison with the use of amoxicillin after oral-surgical interventions, and therefore antibiotic combination of amoxicillin and clavulanic acid is recommended for use in further practice.

This study tested whether levofloxacin, at a new high dose of 750 mg, was effective for the treatment of complicated skin and skin-structure infections (SSSIs). Patients with complicated SSSIs (n=399) were randomly assigned in a ratio of 1:1 to 2 treatment arms: levofloxacin (750 mg given once per day intravenously [iv], orally, or iv/orally) or ticarcillin-clavulanate (TC; 3.1 g given iv every 4-6 hours) followed, at the investigator's discretion, by amoxicillin-clavulanate (AC; 875 mg given orally every 12 hours). In the clinically evaluable population, therapeutic equivalence was demonstrated between the levofloxacin and TC/AC regimens (success rates of 84.1% and 80.3%, respectively). In the microbiologically evaluable population, the overall rate of eradication was 83.7% in the levofloxacin treatment group and 71.4% in the TC/AC treatment group (95% confidence interval, -24.3 to -0.2). Both levofloxacin and TC/AC were well tolerated. These data demonstrate that levofloxacin (750 mg once per day) is safe and at least as effective as TC/AC for complicated SSSIs.

Acute interstitial nephritis (AIN) is often induced by drug therapy and accounts for 1%-3% of adult cases of renal failure. A 13-year-old white female with cystic fibrosis developed two episodes of biopsy proven AIN following antibiotic use over a 5-year period. The first episode resolved with pulse steroid therapy and the second resolved without intervention. Steroid therapy may play a role in aborting subsequent AIN attacks.

The efficacy and tolerability of once- or twice-daily ceftibuten (400 mg daily) were compared with three-times daily amoxicillin/clavulanate (AMX/CA, 500 mg/125 mg) in the treatment of acute exacerbations of chronic bronchitis (AECB) in an open, parallel-group 10- to 14-day study in 443 patients. Patients were assessed at baseline and on days 5, 10-14 and after 4-6 weeks of treatment, and the clinical response defined as cured, improved, stabilized or failed. Clinical efficacy between the 3 groups was equivalent (p = 0.002) with 90% of patients in each group responding to treatment (cured or improved) and the incidence of complete cures (with no clinical signs of relapse) was also equivalent. In conclusion, this study showed that ceftibuten is clinically equivalent to a standard regimen of amoxicillin/clavulanate in the treatment of AECB, including those patients infected with Streptococcus pneumonia. Ceftibuten was better tolerated than AMX/CA and was associated with significantly fewer gastrointestinal side effects. Furthermore, once-daily was a well tolerated and effective as twice-daily ceftibuten.

Children with acute otitis media (AOM), aged 2-12 years, were randomised to 10 days treatment with amoxycillin/clavulanate (A/C) 70/10 mg/kg/day given b.i.d. (231 patients) or to A/C 60/15 mg/kg/day given t.i.d. (232 patients). Clinical success rates at end of therapy (10-17 days) were 91.8% for the b.i.d. group and 90.5% for the t.i.d. group and at follow-up (28-42 days) were 80.1% for the b.i.d. group and 77.6% for the t.i.d. group, indicating that the b.i.d. regimen was as effective as the t.i.d. regimen. There was no statistically significant difference in incidence of adverse experiences between the two groups. The overall incidence of protocol defined diarrhoea assessed from diary booklets was low, with a lower incidence in the b.i.d. group (6.7%) than in the t.i.d. group (10.3%). Significantly more patients in the b.i.d. group (83.1%) than in the t.i.d. group (72.8%) had at least 80% compliance over a 7-10 day treatment period. A/C given twice or three-times daily was highly effective in the treatment of AOM in children. The two regimens showed equivalent clinical efficacy, both were well tolerated, and there was evidence of improved compliance with the b.i.d. regimen.

Toxic hepatitis is an infrequent secondary effect of amoxycillin-clavulanic acid with fewer than 30 well documented cases in the literature. Presentation is usually that of acute cholestasis several weeks after the initiation of treatment with this antibiotic. A new case of hepatic toxicity by amoxycillin-clavulanic acid is reported in a 47-years-old male who had taken this drug for a diarrhea syndrome. A brief review of the literature is made with special emphasis on the anatomopathologic aspects.

In this double-blind study, 557 patients with lower respiratory tract infection were randomly assigned to receive amoxicillin/clavulanate orally either every 12 hours (875/125 mg) or every 8 hours (500/125 mg) for 7-15 days. For the 455 patients evaluable for clinical efficacy at the end of therapy, clinical success was similar in the two groups: 93% and 94% in the 12-hour and 8-hour groups, respectively (P = .42). Bacteriologic success at the end of therapy was also comparable: 97% and 91% in the 12-hour and 8-hour groups, respectively (P = .86). The occurrence of adverse events related to treatment was similar for the two groups, but fewer patients in the 12-hour group reported moderate or severe diarrhea. Amoxicillin/clavulanate (875/125 mg) given every 12 hours is as effective and safe as every-8-hours administration of the combination (500/125 mg) for the treatment of lower respiratory tract infection.

An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days post therapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.

Clinical and pathological findings of five cases of acute hepatitis due to amoxicillin-clavulanic acid intake are reported. Liver biopsies revealed cholestasis in all cases, associated with varied degrees of interlobular bile duct injury in four patients. There was no ductopenia. These alterations may mimic lesions observed in intra- and/or extrahepatic biliary tract obstruction. Drug-induced intrahepatic bile duct injuries are not uncommon and can lead to diagnosis difficulties.

Amoxycillin/clavulanic acid liver injury is very rare. We describe an exceptional case of intrahepatic cholestasis without hepatitis induced by amoxycillin/clavulanic acid. Recognition of this benign cholestatic syndrome as a side-effect may obviate unnecessary complementary and costly procedures.

Seventy-five pregnant women (mean gestational age 32.26 weeks, range 20-36 weeks) with premature rupture of the membranes (PROM) were admitted in our department during 1989 and the first 6 months of 1990. Amoxicillin and clavulanic acid was initially administered at a dose of 1.2 g i.v. every 8 hours for 3-4 days and was followed by oral administration of 625 mg every 8 hours until labor. Sixty-one patients (mean gestational age 32.6 +/- 2.3 weeks, range 26-36 weeks) achieved an uncomplicated course of their pregnancies with a mean time of 11.4 +/- 5.7 days (range 3-27 days), from rupture to delivery. Fourteen women (mean gestational age 30.8 +/- 5 weeks, range 20-36 weeks) developed chorioamnionitis 3.5 +/- 0.9 days (range 1.4-5.6 days) after the rupture with several degrees of leukocyte infiltration of the membranes, placenta and the umbilical cord. Five women (mean gestational age 23.8 +/- 2.3 weeks, range 20-26 weeks) had complications resulting in fetal/infant death, three of them because of fetal sepsis (Escherichia coli, Pseudomonas aeroginosa, Staphylococcus aureus). The newborns were followed up 6 months from delivery and had no signs of drug influence. Few side effects were observed with the chief complaints involving the gastrointestinal tract (4%). No one discontinued the drug. It seems therefore, that the prophylactic administration of amoxicillin and cluvalanic acid in women with PROM is associated with a significant prolongation of pregnancy and with a reduction in the incidence of fetal/maternal infections.

Background: Amoxicillin-clavulanic acid combination-associated hepatitis and jaundice was first identified in 1988. Numerous case reports and case series have been published since then, but there is no precise estimate of this risk., Methods: A retrospective cohort study in the United Kingdom to estimate the risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid and compare it with the one of amoxicillin alone. Data were derived from a cohort of 93,433 users of the combination drug amoxicillin-clavulanic acid and 360,333 users of amoxicillin alone who were aged between 10 and 79 years and who were followed up from 1991 through 1992. After reviewing the information on subjects with suspected liver injury that was recorded on computer files, the clinical records of 177 patients from the attending general practitioners were requested., Results: They were 35 cases of idiopathic acute liver injury. None was fatal. There were 14 cases of acute liver injury among users of amoxicillin alone. The type of liver injury was hepatocellular in half the cases. There were 21 cases of acute liver injury among users of amoxicillin and clavulanic acid together. The type of liver injury was cholestatic in three quarters of the cases. The incidence rates and 95% confidence intervals (CIs) of developing acute liver injury associated with the combination of amoxicillin and clavulanic acid and amoxicillin alone were 1.7 (1.1-2.7) and 0.3 (.02-0.5) per 10 000 prescriptions, respectively. The rate ratios and 95% CIs of acute liver injury for amoxicillin and clavulanic acid together compared with amoxicillin alone were 6.3 (3.2-12.7) for all patients and 8.4 (3.6-20.8) for patients presenting with jaundice. Among users of amoxicillin and clavulanic acid together, the risk of developing acute liver injury was more than 3 times greater after a course of 2 or more consecutive prescriptions than after a single course of therapy. The risk also increased with age among users of amoxicillin and clavulanic acid together. The combination of advancing age and repeated prescriptions resulted in a risk of developing acute liver injury greater than 1 per 1000 users of amoxicillin and clavulanic acid together.

Objective: Evaluate antibiotic-associated diarrhea and toxigenic Clostridium difficile in stool specimens obtained from children before and after 10 days of amoxicillin/clavulanate for otitis media., Design: Children, 12 to 47 months of age, treated with amoxicillin/clavulanate for otitis media in an outpatient setting were enrolled. Stool specimens were obtained at enrollment, when diarrhea occurred and at the end of therapy. All stool specimens were tested for C. difficile toxins A and B by enzyme immunoassay., Results: Seventy-six children who had stool specimens collected at enrollment and after therapy were included in the analysis. None had C. difficile toxin in stool specimens at enrollment. Six (27%) of 22 children with diarrhea, and 4 (7%) of 54 children without diarrhea had C. difficile toxin present at completion of therapy (P = 0.03)., Conclusion: Toxigenic C. difficile was identified in 13% of children at the conclusion of amoxicillin/clavulanate therapy with a significantly higher frequency in children with diarrhea.

The treatment of community-acquired pneumonia is empirical in most cases and must cover a wide range of potential pathogens, such as Streptococcus pneumoniae, including penicillin-resistant strains, Haemophilus influenzae and intracellular microorganisms. The objective of this double-blind, randomized, parallel group study was to compare the efficacy and safety of sparfloxacin (400 mg loading dose, followed by 200 mg o.d.) with that of oral amoxycillin-clavulanic acid (500/125 mg t.i.d.) or oral erythromycin (1 g b.i.d.), during 7-14 days in 808 patients with confirmed community-acquired pneumonia. The overall success rates for sparfloxacin (87%), amoxycillin-clavulanic acid (80%) and erythromycin (85%) were similar in evaluable patients, and the equivalence hypothesis used for the statistical analysis showed at least an equivalent efficacy for the three antibiotics tested. The analysis of microbiologically documented infections (40% of the patients) showed that overall success rates were similar for S. pneumoniae and H. influenzae infections. Treatment withdrawal was necessary in 3.5, 2.5 and 7.7% of the patients treated with sparfloxacin, amoxycillin-clavulanic acid and erythromycin, respectively. This study indicates that sparfloxacin was at least as effective as amoxycillin-clavulanic acid or erythromycin in the treatment of mild-to-moderate community-acquired pneumonia and that the adverse effects were similar in the three groups.

History and Findings: A 61-year-old woman fell ill with recurrent nausea, loss of appetite and tiredness. Five days later she noted increasing jaundice of skin and sclerae, pale stools and dark urine, and she developed itching over the whole body. Among biochemical tests alkaline phosphatase (537 U/l) and bilirubin (32.0 mg/dl) were markedly increased, while both GOT (102 U/l) and GPT (39 U/l) were only slightly elevated. Ultrasonography was normal and extrahepatic cholestasis appeared unlikely on endoscopic retrograde cholangiopancreatography. Cholestasis due to virus hepatitis was also excluded. It was only on repeated and direct questioning that the patient reported having taken three tablets daily of Augmentin (amoxicillin and clavulanic acid) for 12 days 5 weeks before the onset of symptoms., Treatment and Course: After symptomatic treatment with Colestyramine (4 g three times daily), ursodeoxycholic acid (250 mg twice daily) and the antihistaminic Clemastine (1 g two times daily) the severe pruritus decreased quickly and alkaline phosphatase concentration became normal. At follow-up examination 4 and 8 weeks later the laboratory tests were normal., Conclusions: This report of Augmentin-induced cholestasis is not unique. It shows that previous drug intake must be carefully investigated in any case of cholestasis of unknown cause.

A 25-year old man suffered from acute pancreatitis and cholestatic acute hepatitis simultaneously after 4 weeks of an antibiotic treatment withdrawal (amoxicillin plus clavulanic acid) which was given for pharyngitis. Other potential etiological causes of both acute pancreatitis and liver disease, were excluded. The causal relationship between amoxicillin plus clavulanic acid and cholestatic hepatitis is well know, but no data has been reported regarding acute pancreatitis. The medical literature is reviewed and the mechanisms of toxicity are discussed.

Objective: The purpose of this trial was to determine whether 20 days of antimicrobial treatment is more efficacious than 10 days of treatment for acute otitis media (AOM) in clearing middle ear effusion and preventing recurrences of AOM, and whether changing to a beta-lactamase-stable antimicrobial agent after the initial 10-day treatment with amoxicillin for AOM is advantageous., Methods: Children between 7 months and 12 years of age with AOM were randomly assigned to three treatment groups: (1) amoxicillin for days 1 through 10, then amoxicillin for days 11 through 20; (2) amoxicillin for days 1 through 10, then amoxicillin-clavulanate for days 11 through 20; and (3) amoxicillin for days 1 through 10, then a placebo for either amoxicillin or amoxicillin-clavulanate for days 11 through 20. Medication was dispensed in a double-blind manner. Children underwent tympanocentesis at entry and were re-examined on days 10, 20, 30, 60, and 90 after entry., Results: Two hundred sixty-seven children entered the trial. At the 20-day visit, the percentages of children who were effusion free in the amoxicillin, amoxicillin-clavulanate, and placebo groups were 72.4%, 80.8%, and 52.5%, respectively. There was no statistically significant difference in the percentage of children who were effusion free between the amoxicillin and amoxicillin-clavulanate groups (95% confidence interval, -21.7, 4.9). Subsequent to the day 10 visit, the average proportions of time with middle ear effusion were not significantly different in the amoxicillin, amoxicillin-clavulanate, and placebo groups (0.29, 0.27, and 0.34, respectively), nor were there significant differences in the rates of recurrent episodes of AOM (0.56, 0.59, and 0.68, respectively). Regardless of treatment group, approximately 75% of children were effusion free at the time of their last visit., Conclusions: More children were effusion free by the day 20 visit if given antimicrobial treatment for 20 days rather than for 10 days, but this advantage was present for only a short time; by the end of the 90-day study period, the treatment groups were comparable with regard to effusion status. Recurrence of AOM during the study period was not prevented by the additional 10 days of treatment. Routine use of an additional 10-day course of antimicrobial treatment is therefore not recommended if a child is symptom free after the initial 10 days of treatment for AOM.

The safety and efficacy of clarithromycin was compared with those of amoxicillin-potassium calvulanate for the treatment of acute otitis media in children. In a multicenter, randomized, investigator-blinded trial, 180 patients (6 months to 12 years of age) with acute otitis media were allocated to receive either clarithromycin, 15 mg/kg in two divided doses (n = 90), or amoxicillin-clavulanate, 40 mg/kg in three divided doses (n = 90), for 10 days. Middle ear samples were obtained by tympanocentesis from 175 of 180 patients. Pathogens were isolated from 137 samples (76%). Eighty-six patients in each treatment group were considered for efficacy analysis. Clinical cure or improvement was achieved within 4 days after treatment in 80 (93%) of 86 patients receiving clarithromycin and in 82 (95%) of 86 patients receiving amoxicillin-clavulanate. Recurrence of infection was observed between 5 and 35 days after treatment in 9 (11%) of 80 patients in the clarithromycin group and in 8 (10%) of 82 patients in the amoxicillin-clavulanate group. Middle ear effusion was found with similar frequency at the end of therapy and at follow-up visits in both treatment groups. Mild gastrointestinal signs and symptoms, the most common side effects, were noted in 20% and 52% of patients in the clarithromycin group and the amoxicillin-clavulanate group, respectively (p < 0.001). We conclude that clarithromycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children.

Cefuroxime axetil (CAE), an orally absorbed product of cefuroxime, and amoxycillin/clavulanate (AAC), were evaluated for their efficacy and safety in the treatment of acute sinusitis. A total of 47 patients were enrolled in a randomized study to compare cefuroxime axetil 500 mg. b.d. for 8 days (25 patients) with amoxycillin/clavulanate 500 mg. t.d.s for 8 days (22 patients). All patients were evaluable for clinical, radiological and bacteriological response. Of 25 clinically assessable patients treated with CAE, 24 were cured, 1 improved and 1 relapsed (96% success rate). Of 22 assessable patients given AAC, 14 were cured and 8 improved (100% success rate). Two out of 25 (8%) patients treated with CAE experienced drug-related adverse events, including 4% with diarrhoea. In the AAC group, 3 out of 22 (13%) patients had a drug-related adverse event, including 13% with diarrhoea. In conclusion, CAE appears to be as safe and effective as AAC in the treatment of acute sinusitis.

Charts of 16 patients on ticarcillin-clavulanic acid were examined. Eight patients were found to have hypokalemia, yet not all were screened routinely for potassium imbalance. Some physicians prescribing ticarcillin-clavulanic acid seem unaware of the drug's side effect.

We compared the efficacy and safety of two beta-lactam-beta-lactamase inhibitor combinations, namely, piperacillin-tazobactam and ticarcillin-clavulanate, in the treatment of complicated bacterial infections of skin that required hospitalization. The study was a randomized, double-blind, comparative trial involving 20 centers. The infections were classified as (i) cellulitis with drainage, (ii) cutaneous abscess, (iii) diabetic or ischemic foot infection, and (iv) infected wounds and ulcers with drainage. The clinical response rates were comparable for the two treatment regimens (61% of the patients were cured with piperacillin-tazobactam and ticarcillin-clavulanate and improvement was seen in 15 and 16% of patients treated with piperacillin-tazobactam and ticarcillin-clavulanate, respectively). Both regimens were found to be safe and well tolerated. These data support the use of piperacillin-tazobactam for initial empiric therapy of hospitalized patients with complicated skin and skin structure infections.

An open randomized trial was conducted in 159 children (aged 1 to 8 years) with acute otitis media to compare the clinical efficacy of azithromycin (n = 105) and co-amoxiclav (n = 54). Azithromycin (10 mg/kg/day) was administered as a single dose for three days and co-amoxiclav was given tid for ten days at a dosage according to the manufacturer's instructions for the country. Of 103 evaluable azithromycin patients on day 3 to 5 after the start of therapy, 31 (30%) were considered cured, 67 (65%) improved and five (5%) failed compared with eight (15%) cured, 45 (83%) improved and one (2%) failed among the 54 evaluable co-amoxiclav treated patients. There was a higher number of azithromycin patients with complete resolution of symptoms at this first visit (P = 0.056). By day 10 to 12, clinical equivalence between the two treatment groups was observed with clinical cure in 86 (88%), improvement in 11 (11%) and failure in one (1%) of the 98 azithromycin patients, and in the 54 patients treated with co-amoxiclav, clinical cure was observed in 45 (83%), and improvement in nine (17%) patients. Both drugs were well tolerated and treatment related side-effects were reported in 8/105 (8%) azithromycin and 2/54 (4%) co-amoxiclav patients. In the azithromycin treatment group, these were predominantly mild to moderate gastrointestinal effects, whilst in the co-amoxiclav treatment group, both reports were of mild erythematous rash. One patient from each treatment group was withdrawn due to side-effects (azithromycin--diarrhoea and vomiting; co-amoxiclav--erythematous pruritic rash).(ABSTRACT TRUNCATED AT 250 WORDS)

A total of 389 children (age 0.6-10.2 years) with typical signs and symptoms of acute otitis media were randomized (1:1) to treatment with either azithromycin or co-amoxiclav. The dosage schedule for azithromycin was 10 mg/kg/day, in a single daily dose, administered for three days. Co-amoxiclav was given at a dose of 13.3 mg/kg (amoxycillin equivalent) tid for ten days. Patients were evaluated 4-6 days and 12-16 days after the start of therapy. A satisfactory clinical response was reported for 93.2% of the 192 evaluable azithromycin-treated patients (144 cured, 35 improved), and for 97.3% of the 189 evaluable co-amoxiclav-treated patients (148 cured, 36 improved). Six (3.0%) relapses occurred in the azithromycin group, and four (2.1%) in the co-amoxiclav treatment group, respectively. Side-effects were recorded in a significantly fewer number of the azithromycin patients (23 of 197; 11.7%) compared with the co-amoxiclav patients (43 of 192; 22.4%, P < 0.02). Adverse events were mainly gastrointestinal in nature, with diarrhoea the most frequent complaint (32 cases with co-amoxiclav; five with azithromycin; P < 0.001). One patient from each group discontinued therapy because of treatment-related adverse events. Laboratory analyses (mainly haematological in nature) showed abnormalities in six of 100 azithromycin patients and ten of 101 co-amoxiclav patients. It was concluded that three-day, single-dose azithromycin and ten-day tid co-amoxiclav therapy have comparable clinical efficacy in paediatric patients with acute otitis media; however, there was a lower incidence of side effects in the azithromycin group.

This 70-year-old man experienced an episode of cholestatic hepatitis most likely due to an immunologically mediated reaction to amoxicillin-clavulanate. The episode occurred after cessation of the drug combination. Duration of illness was 16 weeks, and the patient recovered completely.

A total of 311 children who had recurrent otitis media or who had experienced failure of initial treatment of acute otitis media with phenoxymethylpenicillin, amoxicillin, ampicillin esters or cefaclor were entered into a single-blind study in two parallel groups in order to compare the clinical efficacy and safety of amoxicillin/clavulanate suspension given b.i.d. or t.i.d. for seven days. The patients were examined prior to the start of treatment, at an early follow-up visit 9 to 12 days after the start of treatment and at a late follow-up visit about three weeks later. Specimens for bacteriological culture were taken from the nasopharynx at entry, at the early follow-up visit, and at the late follow-up visit if there were symptoms of otitis. Both treatment groups showed a similar response, 90% or more of the patients being cured or showing improvement at the time of the early follow-up visit. The initial nasopharyngeal cultures showed growth of Haemophilus influenzae in 53% of the patients, Moraxella catarrhalis in 43% and Streptococcus pneumoniae in 39%. After treatment, cultures showed elimination of the initial pathogens in 30% of patients in both groups and recolonization in 23% in both groups. Haemophilus influenzae was the bacteria most frequently found in the nasopharynx at the first follow-up visit. Adverse effects, which consisted mostly of gastrointestinal and dermatological reactions, tended to be more common in the b.i.d. group but the difference was not statistically significant.

The objective of this open-label, randomized, multicenter study was to compare the efficacy and safety of fleroxacin, 400 mg administered orally once daily, and amoxicillin/clavulanate potassium (AMX/CP), 500 mg/125 mg administered orally three times daily, for 4-21 days to patients with skin and soft tissue infections (SSTIs). The specific diagnoses in both groups were primarily skin abscess, impetigo, and skin ulcer, as well as wound infection erysipelas, folliculitis, cellulitis, and lymphangitis. A total of 285 patients were randomized to treatment in a 2:1 ratio, 190 in the fleroxacin group and 95 in the AMX/CP group. Adult male or female inpatients or outpatients were included in the trial and were followed up after 3-5 days of therapy and 3-9 days after completion of therapy for assessment of bacteriologic, clinical, and safety parameters. The most frequently isolated pathogen in both treatment groups was Staphylococcus aureus. Bacteriologic cures were observed in 87 (76%) of 115 evaluable patients in the fleroxacin group and in 41 (72%) of 57 evaluable patients in the AMX/CP group. Clinical cure was seen in 86 (75%) of 114 patients in the fleroxacin group and 45 (79%) of 57 patients in the AMX/CP group. Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group. In both groups, most adverse events were mild or moderate in severity and involved the digestive system (primarily diarrhea, nausea, and vomiting). In the fleroxacin group, adverse events affecting the central nervous system (mainly dizziness, insomnia, somnolence) also were reported. In this study, both fleroxacin and amoxicillin/clavulanate potassium were effective and well tolerated in the treatment of skin and soft tissue infections.

Oral fleroxacin, 400 mg once a day, and oral amoxicillin/clavulanate potassium (AMX/CP), 400 mg/125 mg three times a day, administered for 4-21 days, were compared for efficacy and safety in the treatment of skin and soft tissue infections. A total of 113 patients were enrolled in a multicenter, randomized, double-blind trial; 57 were assigned to fleroxacin and 56 to AMX/CP. A total of 22 and 33 patients in the fleroxacin and AMX/CP groups, respectively, were evaluable for efficacy. The most common diagnoses were skin abscess (14; 62%) and wound infections (5; 23%) in the fleroxacin group and skin abscess (17; 52%) and skin ulcer (9; 27%) in the AMX/CP group. A total of 20 (91%) of the fleroxacin-treated patients and 29 (88%) of the AMX/CP-treated patients were bacteriologically cured (two fleroxacin- and one AMX/CP-treated patients developed super-infection). The eradication rate for Staphylococcus aureus was 100% (11 of 11) in the fleroxacin group and 89% (17 of 19) in the AMX/CP group; 18 (82%) of the fleroxacin group and 25 (76%) of the AMX/CP group were clinically cured. Adverse events were seen in 22% (12 of 54) of the fleroxacin group and 25% (13 of 53) of the AMX/CP group. None were serious. Bacteriologic and clinical cure rates and safety results for the two groups were similar. The small sample size precluded statistical analysis at the 95% confidence level.

In a multicenter, prospective, randomized trial, fleroxacin was compared with amoxicillin/clavulanate potassium (AMX/CP) for the treatment of infections of skin and soft tissue. Fleroxacin was given at a dosage of 400 mg once daily, and AMX/CP was given at a dosage of 500 mg/125 mg three times a day. Each was administered for 4-21 days. Adult patients with the clinical diagnosis of skin or soft tissue infections were eligible for enrollment. Patients were randomized in a 2:1 ratio. A total of 191 patients were enrolled; 126 took fleroxacin, and 65 took AMX/CP. Of these patients, 42 in the fleroxacin group and 26 in the AMX/CP group were evaluable for both clinical and bacteriologic efficacies. Patients with abscesses comprised the largest single category in each group. Principle reasons for exclusion included: patients lost to follow-up (17 [13%] fleroxacin, 12 [18%] AMX/CP); failure to isolate a causative pathogen (19 [15%] fleroxacin, 9 [14%] AMX/CP); and resistance to study drug (11 [9%] fleroxacin, 2 [3%] AMX/CP). Staphylococcus aureus was the most commonly isolated pathogen. Streptococcus group A, Staphylococcus coagulase-negative, Escherichia coli, and Proteus species, in decreasing order, were the next most common pathogens. Clinical and bacteriologic efficacy was excellent in both groups, with a cure rate of > or = 90%. There were two bacteriologic failures in each group. Patients taking fleroxacin complained of slightly more adverse events, which involved primarily the digestive and central nervous systems. The rate of withdrawal from the study because of adverse events was 4% in both groups. Fleroxacin, 400 mg given once daily, is safe and as effective as AMX/CP in the treatment of skin and soft tissue infections in adults.

The efficacy and safety of a once-daily oral regimen of 400 mg ceftibuten was compared with oral co-amoxiclav 500 mg three times daily in a multicentre, single-blind study. In patients with a bacteriologically confirmed infection, a successful clinical outcome was reported in 25 of 25 patients treated with ceftibuten and 10 of 10 patients treated with co-amoxiclav. In a further group of 88 patients, most of whom had been excluded from the primary efficacy evaluation because no pathogen was isolated pretreatment, overall successful clinical outcomes of 87% and 88% were reported for ceftibuten and co-amoxiclav, respectively. The duration of treatment and the time to resolution of the signs and symptoms of sinusitis were not significantly different in the two treatment groups. The incidence of adverse events was higher in the co-amoxiclav-treated patients (31% versus 15% in the ceftibuten group) as was the incidence of severe events (10% for co-amoxiclav-treated patients versus < 1% in the ceftibuten group). In summary, once-daily ceftibuten can be considered a safe and effective treatment for acute bacterial sinusitis.

Purpose: This multicenter study compared the clinical and bacteriologic efficacy of two oral antibiotics, cefuroxime axetil and amoxicillin/clavulanate, in the treatment of acute bacterial maxillary sinusitis., Patients and Methods: Three hundred seventeen patients with clinical and radiographic evidence of acute maxillary sinusitis were enrolled at nine centers and were randomly assigned to receive 10 days of treatment with cefuroxime axetil 250 mg twice daily (n = 157) or amoxicillin/clavulanate 500 mg three times daily (n = 160). Patients were assessed for both clinical and bacteriologic responses once during treatment (5 to 7 days) and twice after treatment (1 to 3 days and 4 weeks). Bacteriologic assessments were based on needle aspirates of the maxillary sinus obtained pretreatment and, when possible, at the first posttreatment visit., Results: Organisms were isolated from the pretreatment sinus aspirates of 198 of 317 (62%) patients, with the primary isolates being Streptococcus pneumoniae (22%), Haemophilus spp. (17%), Staphylococcus aureus (13%), and Haemophilus influenzae (10%). A satisfactory clinical outcome (cure or improvement) was achieved in 85% (98 of 115) and 82% (102 of 124) of the clinically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.446). With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 84% (31 of 37) and 87% (34 of 39) of bacteriologically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (p = 0.567). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events (13% versus 3%, p = 0.001), particularly diarrhea (8% versus 1%, p = 0.001). Two patients in the cefuroxime axetil group and three patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events., Conclusions: Our results indicate that cefuroxime axetil twice a day is as effective as amoxicillin/clavulanate three times a day in the treatment of acute bacterial maxillary sinusitis but produces fewer adverse effects.