cefotaxime and Otitis-Media-with-Effusion

Topics: Acute Disease; Amoxicillin; Anti-Infective Agents; Cefixime; Cefotaxime; Humans; Otitis Media with Effusion; Pneumococcal Infections; Treatment Failure

In two randomized clinical trials in children with otitis media, the efficacy and safety of cefprozil are compared to those of amoxicillin/clavulanate (n = 530) and of cefaclor and cefixime (n = 394). The rate of clinical cure or improvement was similar among patients receiving each drug regimen, ranging from 78% for amoxicillin/clavulanate to 89% for cefaclor; for cefprozil, this rate was 84% and 85% in the two studies, respectively. In the first study, cefprozil was superior to amoxicillin/clavulanate in the satisfactory clinical response rate for Streptococcus pneumoniae (P = .049), but response rates were similar for Haemophilus influenzae and Moraxella catarrhalis. Significantly more patients treated with amoxicillin/clavulanate (P less than .001) in the first study or cefixime (P less than .01) in the second study developed diarrhea than did those treated with cefprozil. We conclude that cefprozil therapy for otitis media in children produces clinical and bacteriologic response rates similar to those seen with amoxicillin/clavulanate, cefixime, or cefaclor. Furthermore, diarrhea was significantly less common with cefprozil than with cefixime or amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion

The aim of this study was to determine the potential influence of variables such as the cell content in the fluid, and serum levels, on the concentrations of ceftibuten, cefixime and azithromycin in the middle ear fluid of patients suffering from acute otitis media.. This randomized, open study compared the penetration of ceftibuten (9 mg kg(-1) 18 patients), cefixime (8 mg kg(-1), 16 patients) and azithromycin (10 mg kg(-1) 16 patients) into the intracellular and extracellular compartments of middle ear fluid of 50 paediatric patients (aged 8-14 years) with acute otitis media. Middle ear fluid was extracted by tympanocentesis 4, 12 and 24 h after dosing and divided into two fractions: with cells (as collected) (C+) and cell-free (C-). Antibiotics were assayed in C+ and C- samples by h.p.l.c.. Ceftibuten achieved greater penetration into middle ear fluid than cefixime and azithromycin. Higher concentrations of ceftibuten (CTB) and cefixime (CFX) were found in the C- fraction (CTB: 4h 13.3+/-1.86; 12h 4.7+/-1.18; 24h 0.5+/-0.2. CFX: 4h 3.2+/-1.4; 12h 1.5+/-0.5; 24h>(0.1 mgl(-1)) than in the C+ fraction (CTB:4 h 8.4+/-4.3; 12 h 2.88+/-1.19; 24 h 0.3+/-0.27. CFX: 4 h 1.2+/-0.6; 12 h 0.8+/-0.2; 24 h>0.1 mg l(-1)) at the each time point, while the opposite was true for azithromycin (C-: 4 h 0.11+/-0.04; 12 h 0.12+/-0.08; 24 h 0.23+/-0.12. C+: 4 h 0.38+/-0.24; 12 h 0.9+/-0.03; 24 h 1.05+/-0.3 mg l(-1)).. This study demonstrates that the penetration of antibiotics into the middle ear fluid is influenced by its serum concentrations as well as by the cell content in the fluid. Ceftibuten achieved higher middle ear fluid concentrations than cefixime in C+ and C- fractions at all time points. Both ceftibuten and cefixime concentrations are negatively influenced by the cell content in the fluid. In contrast the concentration of azithromycin to the middle ear fluid is positively influenced by the cell content in the fluid.

Topics: Acute Disease; Administration, Oral; Adolescent; Anti-Bacterial Agents; Azithromycin; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Child; Exudates and Transudates; Female; Humans; Male; Otitis Media with Effusion; Time Factors

With the objective of evaluating the efficacy of cefixime and the combination of cefixime and betamethasone in the treatment of secretory otitis media (SOM), we enrolled 142 children 2 to 12 years old in a randomized, double-blind, placebo-controlled study. All children suffered from SOM, verified by otomicroscopy and tympanometry, of at least 3 months' duration. Active treatment was a 10-day course of cefixime with and without a single dose of 6 mg betamethasone. On hundred forty children were available for efficacy evaluation 14 to 23 days after the start of treatment. A statistically significant treatment effect was found in the group treated with cefixime plus betamethasone (n = 59), with a 44.1% cure rate as compared to 19.7% in the cefixime-treated group (n = 61; p < .005) and 5% in the placebo group (n = 20; p < .005). Relapse rates were high and no statistically differences between groups remained at last valid visit. Adverse events possibly or probably associated with active treatment were reported in 11 cases (9.2%). One patient reported a severe adverse event. No serious events occurred. The study did not show any significant long-term effect of cefixime treatment or any long-term treatment benefit with the addition of betamethasone to the antibiotic.

Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents; Betamethasone; Cefixime; Cefotaxime; Child; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Male; Moraxella catarrhalis; Otitis Media with Effusion; Placebos; Recurrence; Streptococcus pneumoniae; Treatment Outcome

In this randomized, investigator-blinded multicenter study, tympanocentesis for acute otitis media with effusion in 137 ears from 108 children, 6 months to 12 years of age, revealed 84 definite pathogens and 32 potential pathogens. Twenty-nine aspirates from 23 subjects were sterile. Of the 116 isolates 42 (36%) were Streptococcus pneumoniae, 24 (21%) were Haemophilus influenzae, 9 (8%) were Moraxella catarrhalis, 9 (8%) were Streptococcus pyogenes and 1 (1%) was Staphylococcus aureus. Twenty-two (19%) definite pathogens produced beta-lactamase. Patients were randomized to cefixime (8 mg/kg/day daily) or cefaclor (40 mg/kg/day divided into two doses). Efficacy was determined by pneumatic otoscopy and tympanometry at the end of therapy visit on Days 11 to 14 and up to 4 weeks of follow-up. At end of therapy subjects with definite pathogens exhibited a satisfactory clinical outcome in 26 of 36 (72%) ears for cefaclor and 40 of 48 (83%) ears for cefixime recipients (P = 0.12). For ears with beta-lactamase-producing isolates there were no (0 to 12) cefixime failures but 4 of 10 cefaclor failures (P = 0.03). Diarrhea/loose stools were more frequent in cefixime (16 of 58) than cefaclor (4 of 50) recipients. One cefixime subject required discontinuation of drug. Overall efficacy for treatment of acute otitis media with effusion was not different; however, cefixime appeared more effective for infections caused by beta-lactamase-producing organisms.

Topics: Acute Disease; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Drug Resistance, Microbial; Female; Humans; Infant; Male; Otitis Media with Effusion

The efficacy of cefixime was compared with that of cefaclor in the treatment of 63 patients with acute otitis media. Patients received either a single dose of cefixime (8 mg/kg/day) or 3 divided doses of cefaclor (40 mg/kg/day). On the basis of otoscopic and tympanometric results at 10 to 14 days after the start of treatment, 28 (97%) of 29 cefixime-treated patients and 25 (78%) of 32 cefaclor-treated patients had resolution of acute otitis media. The clinical cure rate associated with all organisms was 94% for cefixime (16 of 17 isolates) and 68% (13 of 19 isolates) for cefaclor. The cure rate for Streptococcus pneumoniae was 12 of 12 (100%) for cefixime and 7 of 7 (100%) for cefaclor; the cure rate for Haemophilus influenzae (which includes 2 patients with mixed infections) was 3 of 4 (75%) for cefixime and 2 of 7 (29%) for cefaclor. One clinical relapse occurred among 29 cefixime-treated patients; however, at 28 days 9 recurrences were observed. Three of 25 (9%) cefaclor-treated patients failed and 4 (13%) relapsed at 10 to 14 days, an additional 2 (10%) experienced recurrence by Day 28. Eight (28%) cefixime-treated patients experienced adverse events (7 gastrointestinal and 1 diarrhea and rash); 8 (25%) cefaclor-treated patients experienced adverse events (all gastrointestinal). Our data suggest that both at end of therapy and for 14 days thereafter, cefixime given once a day for acute otitis media is clinically equivalent to cefaclor given 3 times a day.

Topics: Acute Disease; Cefaclor; Cefixime; Cefotaxime; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies; Single-Blind Method

In two randomized clinical trials in children with otitis media, the efficacy and safety of cefprozil are compared to those of amoxicillin/clavulanate (n = 530) and of cefaclor and cefixime (n = 394). The rate of clinical cure or improvement was similar among patients receiving each drug regimen, ranging from 78% for amoxicillin/clavulanate to 89% for cefaclor; for cefprozil, this rate was 84% and 85% in the two studies, respectively. In the first study, cefprozil was superior to amoxicillin/clavulanate in the satisfactory clinical response rate for Streptococcus pneumoniae (P = .049), but response rates were similar for Haemophilus influenzae and Moraxella catarrhalis. Significantly more patients treated with amoxicillin/clavulanate (P less than .001) in the first study or cefixime (P less than .01) in the second study developed diarrhea than did those treated with cefprozil. We conclude that cefprozil therapy for otitis media in children produces clinical and bacteriologic response rates similar to those seen with amoxicillin/clavulanate, cefixime, or cefaclor. Furthermore, diarrhea was significantly less common with cefprozil than with cefixime or amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion

In a double-blind study cefixime, an oral cephalosporin of the third generation, was compared to cefaclor in the treatment of acute otitis media in 397 children aged 6 months to 12 years. Clinical evaluation was carried out at the beginning, at day 10-12 and day 28-35 after the start of the treatment. Specimens for bacterial culture and sensitivity testings were taken from the nasopharynx at the initial visit. Patients were randomized either to cefixime in a dose of 8 mg/kg/day or cefaclor in a dose 40 mg/kg/day in the proportion of 2 cefixime patients to 1 cefaclor patient. Two daily doses were administered for 7 days. At day 10-12, 93.5% in the cefixime group and 90.5% in the cefaclor group (p = 0.08) were clinically cured or improved. At day 28-35 the rate of cured or improved patients had decreased, mostly due to reinfections, to 90.1% in the cefixime group and to 86.6% in the cefaclor group (p = 0.12), respectively. 375 patients (69.9%) had positive bacterial culture in the nasopharynx of at least one strain of Haemophilus influenzae, Streptococcus pneumoniae, Branhamella (Moraxella) catarrhalis or combinations of these 3.73.6% of the B. catarrhalis strains were beta-lactamase producing and 11.4% of the H. influenzae strains, respectively. All isolated bacteria were sensitive to cefixime. Adverse events were reported in 17.9% in the cefixime and 10.6% in the cefaclor group. Most reactions were of moderate or mild nature and mostly affected skin or the gastrointestinal region. No serious adverse experiences occurred. In view of the good clinical results obtained cefixime seems to be at least as effective as cefaclor in the treatment of acute otitis media in children.

Topics: Acute Disease; Anti-Bacterial Agents; Cefaclor; Cefixime; Cefotaxime; Child; Child, Preschool; Diarrhea; Double-Blind Method; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media with Effusion; Streptococcus pneumoniae

Fifty-eight infants and children with acute otitis media were prospectively studied for bacterial and viral pathogenesis and response to antibiotic therapy. Tympanocentesis for bacterial and viral cultures of middle ear fluids (MEF) was done before and 2-4 days after beginning treatment. Patients were followed until the end of antibiotic course. Bacteria were cultured from the preantibiotic MEF in 43 cases (74%). Viruses were cultured from the preantibiotic MEF in 11 cases (19%); all of these MEFs also contained bacterial pathogens. A significantly higher proportion of patients with both virus and bacteria (50%) failed to respond with clearing of bacteria 2-4 days into therapy compared with the group with bacteria alone (13%). The patients with persistently positive viral cultures of the MEF seemed to have purulent otitis of longer duration. Presence of virus in the MEF may interfere with bacteriologic and clinical responses to antibiotic. The mechanism of interference deserves further investigation.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Bacterial Infections; Cefixime; Cefotaxime; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies; Random Allocation; Virus Diseases

Cefixime, a new third generation cephalosporin antibiotic for oral use, was evaluated for safety and efficacy in the treatment of children with acute otitis media with effusion. Fifteen United States clinical investigators participated in the multicenter clinical trial. One hundred twenty children were randomly assigned to a 10-day course of either cefixime, 8 mg/kg, given daily (qd) (60 patients) or amoxicillin, 40 mg/kg/day, administered in three divided doses (60 patients). Tympanocentesis was performed on each patient before therapy was initiated. Pathogens were isolated from a middle ear aspirate in 88% of the cases. Of the specimens from which pathogens were cultured, 33% yielded Haemophilus sp., 41% Streptococcus pneumoniae and 6% Branhamella catarrhalis. Of the 120 patients, 64 (30 cefixime and 34 amoxicillin) were evaluable for assessment of efficacy. Favorable clinical responses (cure or improvement) were obtained in 93% of cefixime-treated patients and in 94% of amoxicillin-treated patients. Overall, bacteriologic eradication rates (as determined by clinical criteria) were 94 and 95%, respectively. Clinical failure or relapse was documented in 2 of 30 (7%) patients treated with cefixime and in 2 of 34 (6%) patients treated with amoxicillin. Gastrointestinal disturbance and rash were significantly more common in children treated with cefixime (22 and 15%, respectively) than in those taking amoxicillin (8 and 2%, respectively), but in only one case was it necessary to discontinue medication because of these adverse effects (rash). Results of this study demonstrate that cefixime given once daily is as safe and effective as amoxicillin in the treatment of acute otitis media with effusion in children and has the possible advantage of less frequent dosing.

Topics: Acute Disease; Amoxicillin; Cefixime; Cefotaxime; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Infant; Male; Otitis Media with Effusion; Random Allocation

Topics: Acute Disease; Cefaclor; Cefixime; Cefotaxime; Cephalexin; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media with Effusion; Patient Compliance

Topics: Acute Disease; Cefixime; Cefotaxime; Cephalosporins; Child, Preschool; Ear, Middle; Humans; Infant; Otitis Media with Effusion

One hundred and four effusions from 66 children with CSOM were cultured for aerobic and anaerobic bacteria. Fifty percent of all effusions yielded bacterial growth and Gram negative organisms constituted 69.2% of those isolates. H. influenza was the most commonly isolated organism (36.5%) followed by B. catarrhalis and Str. pneumoniae. All B. catarrhalis, Staph. aureus and pseudomonas isolates were resistant to ampicillin while cefotaxime was active against all the isolated Gram positive and Gram negative bacteria. Considering B-lactamase production, all the isolated Staph. aureus were BLPs while in case of Gram negative bacteria, not all the ampicillin resistant strains were BLPs.

Topics: Ampicillin Resistance; Bacteria; Bacterial Infections; Cefotaxime; Child; Child, Preschool; Developing Countries; Egypt; Female; Humans; Infant; Male; Otitis Media with Effusion

There is concern that third-generation cephalosporins may not be effective in the treatment of acute otitis media due to Streptococcus pneumoniae. Using the chinchilla animal model, we compared two third-generation cephalosporins, cefixime (Suprax) and ceftibuten (investigational), with ampicillin and saline controls in an investigator-blinded, randomized trial. Whereas the saline controls performed worse than all other groups, no significant differences were detected among the three antibiotics regarding the time required to sterilize the middle ear cleft, or the prevalence of positive cultures after 10 days of therapy. The statistical power of the comparisons of cefixime and ceftibuten with ampicillin were 98% and 67%, respectively. The results of this in vivo animal study fail to support the contention that the two third-generation cephalosporins investigated are not effective in the treatment of pneumococcal acute otitis media. Caution is advised when extrapolating these results to the general clinical setting.

Topics: Acoustic Impedance Tests; Acute Disease; Ampicillin; Animals; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Chinchilla; Drug Evaluation, Preclinical; Otitis Media with Effusion; Pneumococcal Infections

This study considers the efficacity of the ambulatory aerosol therapy in chronic cases of the ENT area. A nebulizer, air-jet type, of 4 microns MMAD, was the device employed, and an ample spectre antibiotic (cefotaxime) a mucolytic (N-acetyl-cysteine) plus a corticoid (methyl-prednisolone) the associated drugs. The antibiotic was discarded when otitis were the problem. The results have been favourable in 75 percent of the cases whilst negative in the resting 24 percent of the treated subjects.

Topics: Acetylcysteine; Aerosols; Ambulatory Care; Cefotaxime; Drug Evaluation; Humans; Methylprednisolone; Otitis Media with Effusion; Paranasal Sinus Diseases; Time Factors

The efficacy of a new third-generation cephalosporin, cefixime, in the treatment of acute otitis media resulting from infection with ampicillin-resistant, beta-lactamase-producing nontypable Haemophilus influenzae, was evaluated using the chinchilla animal model. The results showed that cefixime, administered in moderately low doses (8 mg/kg of body weight, two times per day), readily penetrated the chinchilla middle ear and rapidly sterilized the effusion. The data also suggest that the effusions were resolved more quickly in the cefixime-treated group compared with a group of animals treated with ampicillin or an untreated control group. No adverse side effects were noted in the cefixime-treated animals. The results of this study warrant the testing of cefixime for acute otitis media in the clinical setting.

Topics: Ampicillin; Animals; beta-Lactamases; Cefixime; Cefotaxime; Chinchilla; Haemophilus Infections; Haemophilus influenzae; Otitis Media with Effusion

The ability of cefixime or amoxicillin to eradicate causative pathogens was evaluated in 140 infants and children with acute otitis media with effusion. When pretherapy and on-therapy bacteriologic cultures were used, success was defined as elimination of pathogens regardless of clinical improvement. Parent compliance with administration instructions was closely monitored. Cefixime was administered daily or twice daily and because results on the two dosage regimens did not differ, data were combined for analysis. Results suggested that cefixime was somewhat more effective than amoxicillin for acute otitis media with effusion caused by Haemophilus influenzae but less effective for infections caused by Streptococcus pneumoniae. The study agents were equally effective against Branhamella catarrhalis.

Topics: Acute Disease; Amoxicillin; Bacteria; Cefixime; Cefotaxime; Humans; Microbial Sensitivity Tests; Otitis Media with Effusion; Patient Compliance

Cefotaxime levels were measured in the middle ears of 12 children, after operations for insertion of a transtympanic aerator for serous or relapsing otitis. Mean auricular cefotaxime levels were 4,3 and 5,1 mcg/ml on the right and left respectively. Mean serum level one hour after 25 mg/kg i.m. was 14,5 mcg/ml. In can be concluded that cefotaxime penetrates effectively into the middle ear. Its use should be reserved for difficult or menacing cases of otitis, but its bacteriological activity with regard to Haemophilus influenzae and certain enterobacteria is of value in cases where ampicillins may be ineffective due to resistance of strains.

Topics: Biological Availability; Cefotaxime; Child; Child, Preschool; Ear, Middle; Female; Humans; Infant; Male; Otitis Media with Effusion; Recurrence; Time Factors

Topics: Cefotaxime; Child; Haemophilus Infections; Haemophilus influenzae; Humans; Otitis Media; Otitis Media with Effusion