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The efficacy and safety of two antibiotic regimens for the treatment of acute pelvic inflammatory disease (PID) was compared in a prospective and randomised study. 57 patients received either 0.2 gms ciprofloxacin intravenously b.i.d. in combination with 0.5 g metronidazole intravenously t.i.d. (n = 26), or alternatively 2 g cefoxitin intravenously t.i.d. in combination with doxycycline 0.1 g b.i.d. (n = 31). After commencing therapy intravenously, medication with ciprofloxacin, metronidazole and doxycycline was continued orally after two or three days. In the ciprofloxacin/metronidazole group, PID was found to be severe in 7, moderate in 12 and mild in 7 patients. The numbers in the cefoxitin/doxycycline group were 8, 20 and 3 respectively. The clinical result after treatment with ciprofloxacin/metronidazole was resolution of all symptoms in 24 patients and improvement in 2 others. In the cefoxitin/doxycycline treated group, resolution was found in 27 patients, improvement in 2 others. Failure occurred in 2 patients. 53 different microorganisms as the suspected cause of PID were isolated in the ciprofloxacin/metronidazole group and 56 in the cefoxitin/doxycycline group. According to our clinical and bacteriological criteria, treatment for PID was successful in 97% of the ciprofloxacin/metronidazole group and in 87% of the cefoxitin/doxycycline group. Adverse reactions were found in 4 patients in the ciprofloxacin/metronidazole treated group. Therapy had to be terminated in 3 of these patients. In the cefoxitin/doxycycline group 2 patients had adverse reactions, and therapy had to be terminated in one of these patients. According to our results, both antibiotic regimens can be recommended for the treatment of PID.

As has been proved before, antibiotic prophylaxis is highly effective in lowering wound infection rates in colorectal surgery. In order to establish quality control, we checked the effectiveness of three different prophylactic antibiotic regimes in 422 patients in a prospective and randomized trial. Between the three groups were no significant differences as regards age, type of operation and risk factors like adipositas and diabetes. The wound infection rate according to CDC-criteria was from 7.0 to 9.5%. We did not find a significant difference between the three antibiotic regimes. It is therefore our conclusion, that in our setting each of the three different types of antibiotics is of equal value. This means, on the other hand, that the cheapest one is enough.

The identification of pathogens and the early recognition of pelvic infections in patients after hysterectomy, cesarean delivery and vaginal delivery were analyzed. Criteria for administering cephamycin therapy were established, as were guidelines for evaluating the progress of the infection. In a comparative study of the safety and efficacy of cefmetazole and cefoxitin in 145 hospitalized patients with pelvic infections there were no significant differences between either the bacteriologic or clinical cure rates of the two antibiotics. Both were efficacious and safe for the treatment of obstetric-gynecologic soft tissue infections.

A total of 19 patients who had local or systemic infections with a variety of difficult-to-treat blood disorders were treated with cefoxitin (CFX). The following findings were obtained. 1. Fifteen out of 19 patients' responses were judged "excellent" or "good" with an overall cure rate of 78.9%. 2. As to the side effects of CFX, transient elevations in S-GOT, S-GPT were observed in 3 patients, urine protein in 2 patients, and hematuria in 1 patient. However, these abnormalities cannot be solely attributed to CFX because these patients were treated with either antitumor agents or aminoglycosides, and some had undergone blood transfusions. 3. CFX should be considered for the treatment of severe infections because it is well tolerated, has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative pathogens and is highly resistant to beta-lactamases.

This clinical trial was designed to evaluate the efficacy, safety and patient tolerance of cefoxitin (CFS) in 46 patients who were admitted to the hospitals from June 1983 to April 1984. The daily doses of CFX for 34 patients (ages ranged from 6 to 75 years old) were 2 to 8 g to prevent the infections and for 12 patients (ages ranged from 55 to 81 years old) were 2 to 6 g to treat the infections by intravenous drip infusion 1 or 3 times a day in divided doses. The following results were obtained. All of 34 patients with intracranial operation who received CFX for prevention of postoperative infections showed good results. Of 12 patients with postoperative pneumonia, infections of urinary tract and late meningitis, 11 patients showed good results. One patient was discontinued on the 3 days because of the drug eruption which improved 3 days after. The side effect was noted in only 1 patient. This was eruption which improved 3 days after the stop of the administration. The influences to the laboratory data due to CFX were not recognized. The results of this study demonstrated that CFX was an excellent drug for the prevention and treatment of the postoperative infections in the neurosurgical field because of high efficacy rate and safety.

Using a new cephamycin antibiotic, cefoxitin, clinical studies were carried out, and the following results were obtained: (1) Cefoxitin was administered to 52 children with 38 respiratory tract infections, 2 urinary tract infections, 1 acute otitis media and others, who ranged in age from 2 months to 11 years old. (2) Cefoxitin was given intravenously at a daily dose of 27.3 mg/kg to 110.5 mg/kg. (3) The overall efficacy rate was 80% in 46 cases, i.e., excellent in 10, good in 27, fair in 7 and poor in 2. (4) Clinical side effects were not seen except exanthema in 1 patient. Elevation of GOT and GPT was seen in 2 patients, elevation of A1-P in 1 and eosinophilia in 2 by laboratory tests. However, these findings were alleviated rapidly following the cessation of therapy.

A total of 20 hospitalized patients underwent orthopedic surgery in the Tokyo Metropolitan Police Hospital during the period from December 1981 to March 1982. These patients were treated with cefoxitin, mainly, for the prevention of postoperative infections. The following clinical findings were obtained. 1. Out of the 20 patients, 14 were judged 'good' and 6 'fair'. 2. No side effects were reported by the patients or were evident in the clinical data. 3. These clinical results indicated that cefoxitin is a very effective antibiotic for the prevention of postoperative infections in orthopedic surgery.

Intravenous cefazolin and cefoxitin were compared in a prospective randomized trial in infections where the suspected pathogen was expected to be susceptible to both antibiotics. In the cefazolin group (12 patients) the diagnosis was pneumonia in 4, including 2 with pneumococcal bacteremia, soft tissue infection in 5, Staphylococcus aureus bacteremia in 1, acute pyelonephritis in 1, and disseminated gonococcal infection in 1. In the cefoxitin group (10 patients) the diagnosis was pneumonia in 4, including 2 with pneumococcal bacteremia, soft tissue infection in 4, acute pyelonephritis in 1, and disseminated gonococcal infection in 1. In the cefazolin group receiving an evaluable course of therapy, a good clinical response was seen in 10 of 11 patients, and a bacteriological response was seen in 5 of 7. Cefazolin failed to eradicate S. aureus bacteremia in 1 patient and S. aureus in a skin ulcer of another patient. All 10 cefoxitin patients had good clinical and bacteriological responses, but in 1 patient S. aureus colonization of a postoperative wound recurred after discontinuation of the drug. Side effects in both groups included skin rash, phlebitis, and elevation of the serum alkaline phosphatase. Both cefoxitin and cefazolin appeared effective in infections caused by susceptible aerobic pathogens with the possible exception of S. aureus, although all 11 strains of S. aureus isolated in this study were susceptible in vitro to both antibiotics. Cefoxitin appeared to be equivalent to cefazolin in efficacy and occurrence of side effects.

Clinical and bacteriological efficacy, patient tolerance, and toxicity of cefoxitin, a beta-lactamase-resistant cephamycin, were evaluated in 38 patients; 13 had soft tissue infection, 12 had pneumonia, 3 had urinary tract infection, 2 had peritonitis, and 4 had miscellaneous infections. In five patients, infection was clinically evident, though not bacteriologically proven. The latter patients were evaluated with regard to tolerance and toxicity only. Among the 34 infections in 33 patients, 71% were considered clinically cured; 86% of those patients who could be recultured were bacteriologically cured. Phlebitis was noted in 32% of the total group, and eosinophilia was observed in 16%. Unexplained deterioration in renal function occurred in two patients. Mean peak cefoxitin levels in serum were 72 mug/ml 30 min after a 2-g infusion and 32 mug/ml 30 min after a 1-g infusion. Cefoxitin was more active against facultatively and obligately anaerobic gram-negative organisms isolated from these patients than was cephalothin.

Unlabelled: A total of 24 patients who was hospitalized in the Internal Medicine Wards of Yamaguchi University attached Hospital and the university's 3 related hospitals were administered with cefoxitin. The breakdown of the patients treated with cefoxitin was 7 with cholecystitis, 7 with choledochitis and the remaining 10 for the prevention of infections with obstructive jaundice. Daily doses of 2-6 g of cefoxitin were administered for 6-40 days by intermittent intravenous drip infusion in divided doses., Results: 1. Of 14 patients with biliary tract infections, 10 (71.4%) responded favorably with cefoxitin. 2. Of 10 patients with obstructive jaundice used for the prevention of infections, 8 (80%) responded favorably with cefoxitin. 3. No untoward side effects were observed. 4. Cefoxitin proved to be a safe and effective antibiotic in the treatment of biliary tract infections and for the prevention of infections in patients with obstructive jaundice.

Cefoxitin (CFX) was evaluated for its safety and efficacy in children. Fifteen patients were treated with 73-125 mg/kg per day of CFX by intravenous administrations. The diagnosis of the patients were acute pharyngitis (4), pneumonia (2), pertussis and pneumonia (1), urinary tract infection (3); and the remaining 5 patients were esteemed to have nonbacterial infections. All the 10 patients of bacterial infections were cured after the CFX therapy. The pathogens recovered were Streptococcus pyogenes (1), Streptococcus pneumoniae (3), Haemophilus influenzae (2), Escherichia coli (2), enteropathogenic Escherichia coli (1), and Klebsiella pneumoniae (1). All the strains isolated were susceptible to CFX, but the 2 isolates of Haemophilus influenzae had relatively high MIC values (12.5 mcg/ml). Diarrhea (3 cases) and transient neutropenia (1 case) were found to be associated with the CFX therapy. However, no severe adverse reactions were encountered. Half-life of the serum level was short (24.1 minutes) and excretion into the urine was rapid. CSF concentration obtained 30 minutes after an intravenous injection of 50 mg/kg of CFX in 1 case with inflamed meninges was considerably high (8.3 mcg/ml). CFX appears to be a safe and effective antibiotic when used in children with susceptible bacterial infections.

A double-blind, placebo-controlled trial was performed to assess the value of cefoxitin for prophylaxis against postoperative infection following radical hysterectomy. Infectious morbidity was observed in 35% of 43 patients in the control group and 23% of 31 in the cefoxitin group. In seven control patients (16%) and one patient (3%) in the cefoxitin group the infections were related to the surgical site (p = 0.07). These differences did not achieve statistical significance. Examination of the data revealed a number of other factors, including operating time, patient weight, blood loss, and blood replacement, that were significantly related to the incidence of infectious morbidity. Comparison of the results of the present study with those in the literature indicates that a careful examination of the circumstances prevailing in any particular institution is necessary before a decision is made on strategies to combat infectious morbidity after radical hysterectomy.

The efficacy and safety of ceftizoxime and cefoxitin were compared in a randomized, double-blind study of therapy for lower extremity infections in patients with diabetes mellitus or peripheral vascular disease. Overall clinical responses were satisfactory in 82% (23/28) of patients treated with ceftizoxime and in 68% (17/25) of patients treated with cefoxitin. The difference was not statistically significant. Ceftizoxime had superior in vitro activity against Enterobacteriaceae, especially Enterobacter cloacae, whereas cefoxitin had better activity against the Bacteroides fragilis group. Relapses of infection were common in both groups during long-term follow-up; only about one third of patients in either group maintained satisfactory outcomes after one year. More than half of the patients in both groups responded to one or more courses of medical therapy and avoided major amputations for one year following entry into the study.

A total of 19 pediatric patients received cefoxitin for the treatment of various infections by intravenous injections of a daily dose ranging from 68 to 125 mg/kg body weight dividing the dose into 3 to 4 times per day. The therapeutic efficacy was excellent in 14 cases, good in 4 and fair in 1, the efficacy rate being 95%. As for side effects, 1 case each of rash, diarrhea and eosinophilia were observed, but none of them were serious.

Cefoxitin was administered to 47 patients on an orthopedic service; 1 or 2 g of the drug was given intravenously every 4-8 hr. Thirty-one evaluated patients with acute or chronic infections of bone, joint, or muscle and tendon had an overall rate of cure of 84%. Ten patients with spinal cord injuries who had urinary tract infections due to Serratia or indole-positive Proteus were treated, and all 10 were cured. Significant adverse effects of cefoxitin included one case of fever due to the drug and three cases of superinfection. Cefoxitin therapy was successful in a variety of difficult-to-treat infections, including some of polymicrobial etiology.

Cefoxitin, a new semi-synthetic cephamycin, has been studied in the treatment of patients with a variety of infections. Included have been a number of patients who have impaired renal function. The drug proved to be effective in treating gram-positive, gram-negative and anaerobic infections, and can be given by the intravenous or intramuscular route. Adverse effects occurred in six of 34 patients. These were not usually serious. The presence of renal failure did not interfere significantly with the efficacy of cefoxitin in treating urinary tract infection and it is considered, in contrast to the aminoglycosides, that this preparation can be used successfully without the necessity for measuring blood or urine levels in patients with reduced or unknown renal function.

Clinical trials of cefoxitin, a new cephamycin antibiotic were carried out on 17 infantile patients with infections (respiratory tract infection 15, meningitis 1 and sepsis 1). Two patients of the above patients were excluded from the clinical evaluation except side effects because diseases were out of the object of this study. Cefoxitin was given at a dose of 50-104 mg/kg/day q.i.d. except 1 patient (b.i.d.) by a single intravenous injection for 2-27 days. The clinical efficacy obtained was good in 11 patients, fair in 2 patients and poor in 2 patients. The efficacy rate was 73.3%. Side effects were observed in 4 patients (eosinophilia 1, skin rash 2 and transient elevation of GOT, GPT and LDH 1).

The efficacy of therapy with cefoxitin sodium plus tobramycin sulfate, with the tobramycin therapy discontinued if no cefoxitin-resistant pathogens grew from appropriate cultures, was compared with clindamycin phosphate plus tobramycin therapy in mixed aerobic/anaerobic intra-abdominal and female pelvic infections. Of 96 evaluable patients, 39 (76%) of 51 randomized to cefoxitin and 38 (84%) of 45 randomized to clindamycin were cured and an additional seven (14%) of 51 and three (6.7%) of 45, respectively, were improved. Bacteroides fragilis "group" was isolated from 44 (54%) of 82 patients with appropriate specimens. Duration of aminoglycoside therapy was significantly shorter in patients randomized to cefoxitin and tobramycin (mean, 4.1 +/- 1.8 days vs 7.0 +/- 3.2 days). There was a tendency to greater nephrotoxic reactions in patients randomized to clindamycin and tobramycin. We conclude that cefoxitin plus tobramycin with selective early discontinuation of aminoglycoside therapy is an acceptable regimen for the therapy of mixed aerobic/anaerobic infections.

Cefoxitin was given intravenously to 20 children with the following acute bacterial infections: 10 cases of bronchopneumonia, 6 cases of urinary tract infection, 2 cases of cervical purulent lymphadenitis, 1 case of streptococcosis and 1 case of omphalitis. Clinical effectiveness was obtained in 16 cases out of 20 cases and bacteriological effectiveness in 11 strains out of 15 strains. No side effect was observed except for 1 case with eruption and 1 case with slight elevation of GOT. From the above clinical results, it is apparent that cefoxitin is a useful antibiotic for treating pediatric patients with various kinds of bacterial infections.

In a randomized comparative trial, 45 patients were treated with amdinocillin plus cefoxitin or cefoxitin alone for bacterial soft tissue infections. Most patients were diabetic and had polymicrobial foot infections. The combination of amdinocillin plus cefoxitin was active in vitro against 71 percent of the isolates obtained before therapy as compared with 65 percent for cefoxitin alone. The combination demonstrated synergy for 29 percent of the isolates tested. A satisfactory clinical response occurred in 90 percent and 71 percent of patients treated with the combination regimen and cefoxitin, respectively, (p greater than 0.1). An increase in serum creatinine thought to be due to interstitial nephritis occurred in one patient treated with the combination regimen. The combination of amdinocillin and cefoxitin was effective in mixed soft tissue infections including diabetic foot infections.

The efficacy and toxicity of moxalactam were compared with the efficacy and toxicity of cefoxitin given with or without tobramycin to 109 patients with surgical infections. A total of 66 patients could be assessed for efficacy (33 patients in each group); 13 of the cefoxitin-treated patients also received tobramycin for at least 72 h. Most patients had intraabdominal infections; 17 had peritonitis, 14 had intraabdominal abscesses, and 7 had perforation of a gangrenous appendix. There were 15 patients with necrotizing soft-tissue infections. The predominant pathogens were members of the Enterobacteriaceae and Bacteroides fragilis. The cure rates were 79% (26 of 33 patients) for moxalactam and 88% (29 of 33 patients) for cefoxitin; the difference in cure rates was not statistically significant. In several patients, cultures of purulent intraabdominal exudates were negative, although bacteria were observed after Gram staining; this presumably reflected the potent activity of the antibiotic therapy which had been started before surgical drainage could be carried out. Adverse effects were observed in 18 of 44 assessable patients (41%) in the cefoxitin group and in 12 of 36 patients (33%) in the moxalactam group; the difference in the rates of adverse effects was not statistically significant. Our results suggest that moxalactam is similar in efficacy and toxicity to cefoxitin given with or without tobramycin for the treatment of serious surgical sepsis caused by a mixture of anaerobic and aerobic pathogens.

To determine the unbiased incidence and types of postoperative infection and their alteration(s) by antimicrobial prophylaxis, a prospective double-blind study was performed using perioperative intramuscular cefoxitin or placebo given to premenopausal women undergoing vaginal hysterectomy at Parkland Memorial Hospital. The clinical and surgical profiles of the 2 groups of women were similar, but there were marked differences in their postoperative clinical courses. Only 8% of the 50 women given cefoxitin had major postoperative infection, compared to 57% of the 49 women given placebo (P < .001); this was associated with a 2.8-day reduction in the hospital stay for those given cefoxitin (P < .001). No clinically significant side effects were observed.

In this comparative study, both cefmetazole and cefoxitin were found to be safe and effective in the treatment of skin and soft tissue infections. Greater activity of cefmetazole against some strains of Staphylococcus aureus, Streptococcus pneumoniae, beta-haemolytic streptococci and aerobic Gram-negative bacilli was confirmed. A 90% or better cure rate was achieved with both drugs. At late follow up, three patients treated initially with cefmetazole had recurrent signs and symptoms. However, these three patients had vascular insufficiency which predisposed them to infection. Since cefmetazole has a longer half-life than cefoxitin, it may prove to be more convenient, or more cost effective, or both, in these and other infections.

Cefoxitin was administered to 25 patients on a general surgical service. In 16 of these patients, a bacteriologic diagnosis was made: four patients had peritonitis, one had ascending cholangitis, seven had cellulitis, and four had abscess. The dosage of cefoxitin varied from 4 to 8 g per day and was generally well tolerated, although there were three cases of phlebitis and one superinfection. There was no evidence of renal, liver, or bone marrow toxicity. All isolates of Bacteroides (eight), Escherichia coli (six), and Staphylococcus aureus (five) were sensitive to cefoxitin. Two of three strains of Pseudomonas aeruginosa were resistant. All patients recovered with cefoxitin and corrective surgery. The results indicate that cefoxitin has the potential of replacing combination therapy in some surgical patients.

Eleven paediatric patients ranging in age from 7 weeks to 7 years were treated with intravenous cefoxitin for a variety of moderate or severe infections. All identifiable pathogens were sensitive to cefoxitin and the clinical outcome for every patient was regarded as a cure. Cefoxitin was well tolerated by all patients, the institution of therapy being associated in many cases with a rapid improvement in clinical condition.

Clinical studies were done on cefoxitin (CFX), the first cephamycin antibiotic, in the field of obstetrics and gynecology and following results were obtained. CFX was administrated by intravenous drip infusion for average 6.9 days at a daily dose of 2--6 g to 58 patients; 15 with intrauterine infections, 5 with intrapelvic infections, 11 with adnexitis, 3 with mastitis, 5 with urinary tract infections, 2 with other infections and 17 for prophylaxis of postoperative infections. The clinical results were excellent in 8 cases, good in 39 cases, fair in 4 cases, poor in 6 cases and unknown in 1 case, with the efficacy of 82.5%. Total bacteriological effective rate was 88.9%. As to side effects, eruption was observed only in 1 case. From the results of the present study, the usefulness of CFX was demonstrated in the field of obstetrics and gynecology.

Laboratory and clinical studies of CFX were conducted on 30 pediatric inpatients at the Department of Pediatrics of Mie University. The results of the sensitivity evaluation conducted on 37 clinical isolates consisting of 16 species were in accordance with the findings reported hitherto in the literature, i.e., CFX was superior to CEZ and CET in terms of the growth inhibitory effect against Gram-negative rods. The serum peak level was obtained 5 minutes after an intravenous injection of 25 mg/kg, and 15 minutes after a drip infusion of 30 minutes using the same dose. The average terminal half life was 13 minutes 15 seconds for the former and 20 minutes for the latter. Clinical evaluation was made on a total of 22 eligible patients. The results were classified as follows: Excellent in 4 cases, good in 12, fair in 4 and poor in 2. The effective rate of CFX was 72.7%. Side effects observed were vascular pain, rash and vomiting, all of which were mild in nature and disappeared immediately after discontinuation of, or change in the routine of drug administration.

A clinical trial was designed for evaluation of the efficacy, safety, and patient tolerance of cefoxitin. Of 26 patients who could be evaluated clinically, 21 had respiratory tract infections; all but one patient responded satisfactorily to therapy with cefoxitin. There were no adverse systemic reactions, nor was any renal or hematologic toxicity noted. In two instances levels of hepatic enzymes became slightly elevated; these changes were possibly related to administration of cefoxitin. About one-third of patients receiving cefoxitin developed minor local reactions at the site of intravenous administration; however, there was only a single instance of true thrombophlebitis. Results of this study suggest that cefoxitin is a safe and well-tolerated antibiotic that is efficacious in therapy of acute respiratory tract infections caused by bacteria that are sensitive to this drug.

The efficacy, safety and effect of a single, 1-g dose of ceftizoxime on the return of vaginal flora were compared to those of the standard regimen of three 2-g doses of cefoxitin for prophylaxis in 99 randomized women undergoing vaginal hysterectomy. Thirty-four were studied in Dallas and 65 in Los Angeles. Surgical procedures were comparable for all the antibiotic groups, although proportionately more simple hysterectomies were performed in Dallas. The patients received a povidone-iodine vaginal preparation immediately before surgery; vaginal packs, when used, contained no antimicrobial agents. Primary prophylactic failure (operative site infection) occurred in 1 of 52 (1.9%) and 4 of 47 (8.5%) of the ceftizoxime- and cefoxitin-treated patients, respectively, for a nonsignificant difference. All five primary prophylactic failures occurred in the Los Angeles patients. One patient in each antibiotic group developed a urinary tract infection and was classified as a secondary prophylactic failure. Febrile morbidity, length of hospital stay and incidence of adverse effects did not differ by antibiotic. The enterococcus was commonly found in the postoperative vaginal flora and was of no value in predicting operative-site infection. Enterobacter species and Pseudomonas aeruginosa were isolated more commonly in patients who received cefoxitin. Diphtheroids, Staphylococcus epidermidis and Peptostreptococcus species were isolated more commonly in patients treated with ceftizoxime.(ABSTRACT TRUNCATED AT 250 WORDS)

Thirty-two infants and children ranging in age from 3 to 151 months (mean, 26 months) were treated with parenteral cefoxitin (150 mg/kg per day). Ten patients with isolates of Haemophilus influenzae (six with cellulitis, two with arthritis, and two with mastoiditis), four with Staphylococcus aureus (one with lymphadenitis, one with septicemia, and two with abscess), and three patients with Streptococcus pneumoniae (one each with cellulitis, abscess, and arthritis), were clinically and bacteriologically cured by therapy. Two additional patients with septic arthritis and facial cellulitis developed meningitis with H. influenzae type b and S. pneumoniae, respectively. Minimal inhibitory and bactericidal concentrations were 20 mug/ml for one strain of S. aureus and one of H. influenzae type b. The mean peak serum levels were 81.9 and 68.5 mug/ml 15 min after intravenous or intramuscular doses, respectively. The mean elimination half-lives were 42.4 and 40.1 min after intravenous or intramuscular doses, respectively. The mean volumes of distribution were 5,540 and 4,760 ml after intravenous and intramuscular doses, respectively. Mean plasma clearance was 242 and 257 ml/min per m(2) after intravenous and intramuscular doses, respectively. Therapy was discontinued in one patient because of neutropenia, which resolved after cefoxitin was stopped. Eosinophilia and transiently elevated liver function tests occurred in eight and six patients, respectively. These data indicate that cefoxitin may be an effective treatment for infections due to susceptible bacteria in the dosage tested, but its use may be limited because of the occurrence of meningitis during therapy in some patients.

Pharmacokinetics of cefoxitin, a new injectable semisynthetic-cephamycin, was studied in 12 healthy children and also was studied cerebrospinal fluid levels in 1 patient with bacterial meningitis received 44.5 mg/kg of cefoxitin and thoracic fluid levels in 2 patients were measured. Cefoxitin was administered intravenously to 50 patients with various types of infections an average dose of 130 mg/kg/day for an average of 9 days. The results were as follows: 1. Favorable plasma levels were obtained comparing with those off conventional injectable cephalosporins after 15 mg/kg and 25 mg/kg of cefoxitin for one shot intravenous injection. The half lives of cefoxitin in the plasma were about 15.9 minutes up to 1 hour and 25.5 minutes up to 2 hours after an intravenous administration of cefoxitin at a dose of 15 mg/kg, and while, those were 15.9 minutes and 27.5 minutes after an intravenous administration of cefoxitin at a dose of 25 mg/kg, respectively. 2. Cefoxitin was excreted with high concentration up to 2 hours after the administration and thereafter, urinary concentration of cefoxitin declined rapidly with the lapse of time. The time course urinary concentration reflected those of plasma levels. Approximately 94.7% and 90.6% of dosed cefoxitin were recovered in the urine for 6 hours after the administration at the dose of 15 mg/kg and 25 mg/kg, respectively. 3. The cerebrospinal fluid levels of cefoxitin were only determined in a patient of bacterial meningitis. Therefore, further study should be performed. 4. The thoracic fluid levels with 2 patients were higher than cerebrospinal fluid levels. 5. Among the 50 patients with various infections, cefoxitin was clinically effective in 84% and bacterial response in 87%. 6. As adverse reactions, in total 79 patients included exclusive 29 patients, diarrhea occurred in 1 patient, sweating and cough in 1 patient, rash with fever in 4 patients, vascular pain in 2 patients, and leukopenia was observed in 1 patient, eosinophilia in 1 patient, and increase of GOT and LDH were observed in each 2 patients. The other adverse reactions were not experienced.

Ten inpatients at the Second Department of Internal Medicine, Mie University Hospital, developed infections in the course of treatment for hematopoietic disorders and were administered cefoxitin (CFX). Patients suffered from the following infections: pharyngitis, 2; bronchitis, 2; pneumonia, 2; sepsis, 2; bacteremia, 1; suspected cases of bacteremia, 2; and fever of unknown origin, 1. The number of infections totaled 12 as 1 patient with pharyngitis also developed sepsis and 1 patient with pneumonia developed bacteremia. Duration for the administration of CFX ranged between 5 and 18 days with a total dosage of between 30 and 108 g. Of the 10 patients treated with CFX, 9 were treated concomitantly with micronomicin (MCR), doxycycline (DOXY), or sulbenicillin (SBPC), some were treated concomitantly with only 1 of the drugs and some were treated concomitantly with 2 of the drugs. The following clinical results were obtained: Following treatment, 4 patients were considered "excellent", 5, "good", and 3, "poor". Clinical efficacy rate was 75%. Four strains of Gram-positive cocci (1 strain of S. aureus, 2 strains of S. epidermidis and 1 strain of Streptococcus sp.) and 3 strains of Gram-negative rods (2 strains of P. aeruginosa and 1 strain of E. cloacae) were found in the clinical specimens of the 10 patients. These results differed somewhat from reported data that Gram-negative rods such as E. coli, Klebsiella sp., Pseudomonas sp., Serratia sp., are dominant. No serious side effects requiring cessation of treatment were observed. Elevations in the levels of S-GOT, S-GPT, serum alkaline phosphatase, blood urea nitrogen, etc. were observed.(ABSTRACT TRUNCATED AT 250 WORDS)

Cefoxitin is a new antimicrobial agent derived from cephamycin C. Fifty-four hospitalized patients with 63 clinically significant infections were treated with cefoxitin. Fifty-four infections (86%) were cured by therapy with cefoxitin alone or together with local therapy (i.e., heat, elevation, or surgical drainage). Six infections (10%) were not eradicated by the therapy used. Three patients could not be evaluated. Addition of oral probenecid therapy produced increases in levels of cefoxitin in serum and increased the inhibitory and bactericidal levels of cefoxitin in serum to more favorable ratios. Adverse side effects were seen in 19 patients and included positive direct Coombs' tests, increased eosinophil counts, skin rashes, vasculitis, phlebitis, elevation of liver enzymes, and drug-induced fever.

Cefoxitin was administered intravenously to 143 patients, 67% of whom were seriously ill. The rate of cure or improvement was 93%. The study was conducted in two phases; the first was an open, controlled clinical comparison of cefoxitin and cephalothin. In this phase, 28 patients received cefoxitin and 29 received cephalothin. In the second phase, cefoxitin alone was used for the treatment of an additional 115 patients. Twenty bacteremic patients treated with cefoxitin were cured or improved in 95% of cases. The infecting organism was eradicated in all bacteremic patients. All of 14 anaerobic or predominantly anaerobic infections were cured or improved. The infecting anaerobic organism was eliminated in 86% of the cases. Twenty-five patients infected by cephalothin-resistant, cefoxitin-susceptible gram-negative rods were cured. Three patients each with infective endocarditis and osteomyelitis were cured. The incidence of adverse experiences was: 1.4% drug eruption; 2% each asymptomatic serum transaminase elevation and leukopenia; and 2.5% asymptomatic eosinophilia. The incidence of severe thrombophlebitis was 5%. No permanent or serious adverse reactions were encountered. Although the numbers of patients in some categories were too small to permit statistical evaluation, I feel that cefoxitin may be a useful new antibiotic for treatment of infections caused by cehalothin-resistant bacteria and by anaerobic organisms.

A comparative study of the efficacy and safety of cefoxitin and cephalothin in the treatment of serious infections was carried out by 21 investigators. A total of 320 patients were treated with cefoxitin, and 276 patients were treated with cephalothin. In each group 50% of patients could be evaluated. Patients were randomly allocated to groups in open fashion, and final analysis showed that the groups were comparable in terms of sex, age, severity of illness, and duration of therapy. The majority of pathogens isolated were susceptible to both agents, although 13% of gram-negative bacilli and anaerobes were susceptible to cefoxitin alone. The overall percentage of patients cured or improved by cephalothin was 93%; for cefoxitin the proportion was 91%. No statistical differences in response by type of organism or site of infection were shown. Cefoxitin was effective in treating infections and in eradicating the pathogenic bacteria. Cefoxitin was as well tolerated as cephalothin and produced no more adverse reactions or abnormal laboratory findings than did cephalothin. The results of this study demonstrate that cefoxitin is as effective in achieving bacteriologic and clinical cures as is cephalothin and also is effective in treatment of infections due to cephalothin-resistant bacteria.

Following are the results obtained from studies made with cefoxitin in the field of pediatrics: (1) The peak serum level observed upon completion of the one hour drip infusion in a dose of 20-25 mg/kg of cefoxitin varied from 66.4 to 93.0 mcg/ml. This fell to a remarkably low level after 2 hours. The serum half-life varied from 18.84 to 27.86 minutes. (2) The cumulative quantity of cefoxitin excreted in the active form in the urine by the end of 6 hours after completion of the drip infusion was 92.9-93.8%. (3) All of the 42 patients with acute pediatric infection (such as various kinds of acute upper or lower respiratory tract infection, urinary tract infection were treated with either cefoxitin by a single shot (23 patients), or by drip infusion (19 patients). The dosage employed was approximately 50-100 mg/kg/day divided into two to three treatments. There was no major difference in the clinical efficacy between administering two times or three times, the efficacy rates being 96% and 89% respectively. The overall efficacy rate was 93%. (4) In either case of intravenous injections by either a single shot or drip infusion, excellent clinical responses were obtained in most patients. These people had a variety of infections, which were considered to be caused by various kinds of Gram-positive cocci, E. coli (including ABPC resistance), P. mirabilis, Kl. oxytoca and Haemophilus. (5) Out of the 42 patients who received cefoxitin in a daily dose of 5-100 mg/kg divided into two or three times either by a single shot or drip infusion, no hepatic or renal function abnormality was observed except for 2 cases of temporary eosinophilia. (6) On the basis of these results, cefoxitin was found to be a highly useful antibiotic in the treatment of acute pediatric infection caused by microorganisms which are sensitive to cefoxitin.