cefotaxime and Otitis-Media--Suppurative

To compare the use of once-a-day cefpodoxime proxetil to once-a-day cefixime in the treatment of acute suppurative otitis media.. Randomized, multicenter, investigator-blinded.. Outpatient.. A total of 368 patients (age 2 months to 17 years) were randomized to receive either cefpodoxime or cefixime in a 2:1 ratio (245 cefpodoxime, 123 cefixime); 236 patients (155 cefpodoxime, 81 cefixime) were evaluable for drug efficacy.. Patients received either cefpodoxime proxetil oral suspension (10 mg/kg/day, once daily for 10 days) or cefixime oral suspension (8 mg/kg/day, once daily for 10 days).. Clinical evaluations were performed before treatment (study day 1), at an interim visit (study day 3 through 6), at the end of therapy (study day 12 through 15), and at final follow-up (study day 25 through 38). Microbiologic evaluations were performed at enrollment and whenever appropriate thereafter.. End-of-therapy clinical cure rates in evaluable patients were 56% for the cefpodoxime group and 54% for the cefixime group. Clinical improvement rates were 27% for both groups. Clinical response rates were not significantly different between treatment groups (P = .541; 95% confidence interval = -8.1%, 15.2%). At long-term follow-up, 17% of patients in the cefpodoxime group and 20% in the cefixime group had a recurrence of infection. Drug-related adverse events (eg, diarrhea, diaper rash, vomiting, rash) occurred in 23.3% of cefpodoxime-treated patients and 17.9% of cefixime-treated patients (P = .282).. These findings suggest that cefpodoxime proxetil administered once daily is as effective and safe as cefixime given once daily in the treatment of acute suppurative otitis media in pediatric patients.

Topics: Acute Disease; Adolescent; Anti-Infective Agents; Cefixime; Cefotaxime; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media, Suppurative; Prodrugs; Statistics as Topic; Treatment Outcome

A double blind study was carried out to compare the efficacy and safety of cefixime (CFIX), a new oral cephem with cefaclor (CCL) in the treatment of 245 children weighing 10 approximately 30 kg, with acute suppurative otitis media. The daily dosages of CFIX and CCL were 3 approximately 6 mg/kg in 2 divided portions, and 20 approximately 40 mg/kg in 3 divided portions, respectively, and the drugs were administered for 7 days. The results obtained in this study are summarized as follows. Analyzed subjects were 211 patients (CFIX group: 108 patients, CCL group: 103 patients) for clinical efficacy. Efficacy rates judged by the doctor in charge were 88.9% and 83.5% in CFIX and CCL group, respectively, without significant difference between the 2 groups. Similar results were also obtained by the committee. When clinical effects were classified by clinical isolates, the efficacy rates against monomicrobial infections with Gram-negative bacteria were judged by the doctor in charge to be 100% in the CFIX group and 84.6% in the CCL group. Thus CFIX was judged to be significantly superior to CCL (P less than 0.05). The overall eradication rates of bacteria were 97.1% in the CFIX group and 90.3% in the CCL group. The eradication rate of CFIX was significantly superior to that of CCL (P less than 0.05). When improvements of individual symptoms were evaluated, regarding redness of the tympanic membrane and the tympanic cavity on the 3rd day of dosing, CFIX group (improvement in 84.1% of the cases) was significantly superior (P less than 0.05) to the CCL group (67.6%). Regarding purulent secretion on the 7th day of dosing, the CFIX group (improvement in 98.1% of the cases) was also significantly superior (P less than 0.05) to the CCL group (91.3%). Two hundred thirty eight patients were analyzed for side effects (CFIX group: 120 patients, CCL group: 118 patients). The incidence rates of side effects were 0.8% (1/120) in the CFIX group and 1.7% (2/118) in the CCL group, and there was no significant difference between the 2 drugs. From the above results, it is concluded that CFIX is a useful oral antibiotic in the treatment of acute suppurative otitis media in children. Furthermore, CFIX is expected to be equal or superior to CCL in clinical effects.

Topics: Acute Disease; Age Factors; Cefaclor; Cefixime; Cefotaxime; Cephalexin; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Humans; Infant; Otitis Media; Otitis Media, Suppurative

One percent cefmenoxime (CMX) ototopical solution was administered to 302 patients with purulent otitis media and acute diffuse external otitis in open study fashion, and to 216 patients with purulent otitis media in double blind condition. From among the total of 518 cases various bacteria were detected, except 22 of negative detection after incubation and 3 of impossible determination. The main bacteria detected from the above 493 cases were S. aureus (242 strains = 49.1%), P. aeruginosa (105 strains = 21.3%), S. epidermidis (67 strains = 13.6%), Proteus spp. (indole positive) (31 strains = 6.3%) and P. mirabilis (24 strains = 4.9%) as well as anaerobic bacteria (26 strains = 5.3%). MIC of CMX against those bacteria detected was evaluated at 10(8) CFU/ml and 10(6) CFU/ml, respectively, up to the concentration of 800 micrograms/ml, with MIC of cefazolin (CEZ), chloramphenicol (CP) and fradiomycin (FRM) as the references. With respect to the antibacterial action of CMX against S. aureus, MIC50 of CMX was inferior to that of CEZ by 4-fold, but its MIC80 and MIC90 are almost equivalent to those of CEZ. These results were obtained because there existed relatively few CMX highly resistant strains, while more than 20% strains are said to resist cephem antibiotics. As far as MIC of CMX against P. aeruginosa was concerned, the MIC reached its peak with 100 micrograms/ml at the concentration of 10(8) CFU/ml and with 25 micrograms/ml at 10(6) CFU/ml, respectively, which indicated the real antibacterial value of CMX against P. aeruginosa. However, the strains which showed higher MIC of greater than 800 micrograms/ml were rather few, that is, only 8 out of 105 (7.6%). Antibacterial action of CMX against Streptococcus (except Enterococcus), GNR from intestinal bacteria and anaerobic bacteria was favorable, and the stable and strong antibacterial action was shown against C. freundii, Enterobacter spp., S. marcescens and Proteus spp. (indole positive) which produce chromosome mediated beta-lactamase. On the other hand, the antibacterial action of CMX against GNF-GNR except P. aeruginosa was unfavorable for P. cepacia, P. putida and A. xylosoxidans, but relatively favorable for A. calcoaceticus. As a result of MIC evaluation of reference drugs, S. aureus was resistant to CEZ, and Proteus spp. (indole-positive) was resistant to CP, while FRM was highly resisted by almost all strains of bacteria. However, the resistance rate of S. aureus to CP was relatively low, that is,

Topics: Administration, Topical; Bacteria; Cefmenoxime; Cefotaxime; Clinical Trials as Topic; Double-Blind Method; Drug Resistance, Microbial; Humans; Otitis Externa; Otitis Media; Otitis Media, Suppurative; Solutions

Topics: Amoxicillin; Anti-Bacterial Agents; Cefotaxime; Child; Drug Resistance, Multiple; France; Humans; Microbial Sensitivity Tests; Otitis Media, Suppurative; Penicillin Resistance; Pneumococcal Infections; Streptococcus pneumoniae

Topics: Anti-Bacterial Agents; Antitrichomonal Agents; Cefotaxime; Cephalosporins; Child; Humans; Hydrocephalus; Male; Mastoid; Metronidazole; Otitis Media, Suppurative; Sinus Thrombosis, Intracranial; Tomography, X-Ray Computed

Haemophilus influenzae and S pneumoniae are the most common causative agents of acute otitis media in Europe and the USA. This work aimed to identify the agents in Senegal and to study their sensitivity to antibiotics.. Two hundred and one patients, aged 0 to 15 years, with persistent middle-ear effusion, were included in this study from 1983 to 1993. Purulent samples aspirated from the external canal were analysed for bacteriology and sensitivity testing.. Eighty two percent of cultures were positive for Staphylococcus aureus (37%), Pseudomonas aeruginosa (25%), Proteus (18%) and Klebsiella (8%). Positive cultures were found mainly in children aged between 1 and 5 years. Amikacin and cefotaxim were the most active antibiotics against the majority of strains. Staphylococcus aureus was always resistant to penicillin.. Prevalence of Staphylococcus aureus as the causative agent of persistent middle-ear effusion may be explained by late examination. Its resistance to penicillin favors early administration of third generation cephalosporins or pristanimycin.

Topics: Adolescent; Amikacin; Cefotaxime; Child; Child, Preschool; Female; Hospitals, University; Humans; Infant; Infant, Newborn; Klebsiella; Male; Otitis Media, Suppurative; Proteus; Pseudomonas aeruginosa; Retrospective Studies; Senegal; Staphylococcus aureus; Tropical Climate

Topics: Acute Disease; Blood; Cefixime; Cefotaxime; Child, Preschool; Humans; Infant; Otitis Media, Suppurative

The newly developed ceftizoxime rectal suppository (CZX-S) contains 125 mg or 250 mg ceftizoxime (CZX) in potency. From the laboratory and clinical studies on CZX-S, the following results were obtained. Concentration of CZX in serum and palatine tonsil when 250 mg of CZX-S was rectally administered reached the peak level rapidly. The serum levels were 9.39 micrograms/ml in 30 minutes, 6.00 micrograms/ml in 45 minutes, 4.55 micrograms/ml in 60 minutes, 3.87 micrograms/ml in 90 minutes and 2.65 micrograms/ml in 120 minutes. The palatine tonsil levels were 2.73 micrograms/g in 30 minutes, 1.83 micrograms/g in 45 minutes, 1.54 micrograms/g in 60 minutes, 0.99 micrograms/g in 90 minutes and 0.74 micrograms/g in 120 minutes. About 30% of serum concentrations were distributed into palatine tonsil. CZX-S was administered at a daily dose of 375 mg or 750 mg divided 3 times for 4 approximately 9 days in 19 cases of acute suppurative otitis media of children. The overall clinical effect was excellent in 7 cases, good in 7 cases, fair in 2 cases and poor in 3 cases. The effectiveness rate was 73.7%. No side effects were observed in any cases.

Topics: Bacteria; Cefotaxime; Ceftizoxime; Child; Child, Preschool; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Infant; Kinetics; Male; Otitis Media; Otitis Media, Suppurative; Palatine Tonsil; Suppositories