cefuroxime-axetil and Otitis-Media-with-Effusion

Disappearance of middle ear effusion is one of the most important outcomes in the treatment of acute otitis media (AOM).. To evaluate the duration of effusion in AOM treated by antimicrobials and to find factors influencing it.. Parents of 90 children with AOM monitored daily the disappearance of effusion with tympanometry. The children were randomly allocated to be treated with either oral amoxicillin or cefuroxime-axetil for 10 d. Daily monitoring lasted for 14 d or until the tympanogram was normal (curve A or C) in both ears. Pneumatic otoscopy was carried out every 2 wk.. Normal tympanograms were obtained after a median time of 7.5 d (range 1-58 d) among 75 successfully monitored patients. In two-thirds (69%) of them, effusion resolved in 14 d. The median duration of effusion did not differ significantly between the two treatment groups (8 vs 7 days, p=0.7). The children who had unilateral AOM cured more rapidly than those with bilateral AOM (5 vs 19 d, p<0.001). In logistic regression analysis adjusted for age, bilaterality explained treatment failure at 2 wk with an odds ratio of 28.1 (95% CI 4.6-169.5, p<0.001).. The choice of antimicrobials did not influence the duration of middle ear effusion, which was much shorter than had been thought previously. Children with unilateral AOM were cured much more quickly than those with bilateral AOM.

Topics: Acoustic Impedance Tests; Amoxicillin; Anti-Bacterial Agents; Cefuroxime; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Time Factors; Treatment Outcome

Otitis media is a common infection of childhood. Increasing antibiotic resistance rates among the principal causative pathogens, Streptococcus pneumoniae and Haemophilus influenzae, are associated with failure of first line agents.. This open, randomized, multicenter study compared the clinical efficacy of a short 5-day course of cefuroxime axetil (CAE) suspension with that of amoxicillin/clavulanate (A/CA) suspension for 8 or 10 days.. Children age 6 to 36 months with acute otitis media with effusion, diagnosed by tympanocentesis and microbiologic culture, were randomized to receive CAE (30 mg/kg/day in two divided doses for 5 days) or A/CA 40 mg/kg/day in three divided doses for 10 days (A/CA-10). In French centers A/CA was given at 80 mg/kg/day in three divided doses for 8 days (A/CA-8). Patients were assessed 1 to 4 days after completing the course (posttreatment) and followed up at 21 to 28 days after completing the course.. Of the 716 patients randomized, 252 were treated with CAE, 255 with A/CA-10 and 209 with A/CA-8. In the clinically evaluable population, the proportions of patients with clinical cure at posttreatment were 175 of 203 (86%), 181 of 205 (88%) and 145 of 164 (88%) in the CAE, A/CA-10 and A/CA-8 groups, respectively, demonstrating equivalence among the three treatments. For patients <18 months old, clinical cures were 111 of 134 (83%), 116 of 131 (89%) and 83 of 99 (84%) in the CAE, A/CA-10 and A/CA-8 groups, respectively; equivalence was also demonstrated. At follow-up, 130 of 175 (74%) CAE, 121 of 172 (70%) A/CA-10, and 112 of 142 (79%) A/CA-8 had maintained cure. A total of 837 pretreatment pathogens were isolated from middle ear fluid in 73% (522 of 716) patients, the majority of isolates were S. pneumoniae (30%) and H. influenzae (27%). The most common adverse events were gastrointestinal, the incidence of drug-related diarrhea being higher in the A/CA-10 group (18%) than in either the CAE or A/CA-8 groups (10%).. A 5-day course of CAE, given twice daily, was shown to be equivalent to the two regimens of A/CA for treatment of acute otitis media with effusion in children.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefuroxime; Cephalosporins; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Treatment Outcome

Antibiotic concentrations in serum and middle ear effusion (MEE) are important in determining treatment success in acute otitis media, but studies to measure concentration levels are often performed in chronically infected patients where there is little inflammation. In this open, single-center study, 26 patients with acute otitis media were enrolled to assess antibiotic penetration in inflamed ears. Of the 26 patients, 4 were non-evaluable, 6 formed a control group and the others were randomized into three groups. Each of the three groups was given a single oral dose of cefuroxime axetil suspension, 15 mg/kg. Food was administered approximately 20 minutes before the drug in order to maximize drug absorption. Cefuroxime concentrations in serum and MEE were assessed at 2-3 (group 1), 3-4 (group 2) and 4-5 (group 3) hours following dosing. Sampling of MEE was performed with tympanocentesis under local anesthesia and the drug was assayed by HPLC-mass spectrometry. The serum concentrations of cefuroxime were found to be above the minimal inhibitory concentration (MIC) for penicillin-sensitive Streptococcus pneumoniae for 100% of the dosing interval and 42% of the time for intermediate-resistant strains. For both Haemophilus influenzae and Moraxella catarrhalis, serum cefuroxime levels were above the MIC for 42% of the time between doses. This study indicates that cefuroxime axetil penetrates the inflamed middle ear effectively in acute otitis media after oral dosing. Serum levels were maintained above the MICs of important bacterial pathogens in otitis media for more than 5 hours after dosing, which is equivalent to 42% of the dosing interval. Thus, the important statistic of 40-50% of time above MIC, required for beta-lactam antibiotics to produce the maximal bacteriological cure rate of 80-85%, is achieved.

Topics: Acute Disease; Administration, Oral; Cefuroxime; Cephalosporins; Child, Preschool; Drug Monitoring; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media with Effusion; Suspensions; Time Factors

This trial compared the efficacy and safety of a 10-day treatment course of cefaclor and cefuroxime axetil in the treatment of acute otitis media with effusion in children who failed therapy with amoxicillin. This was an investigator-blind, randomized, parallel treatment group study. To be included, patients must have received treatment with a standard clinical regimen of amoxicillin for at least 48 hours and not more than 10 days, with the last dose within 72 hours of randomization. Patients who met the entry criteria were randomly assigned to one of two antibiotic treatment groups. Cefaclor and cefuroxime axetil suspensions were administered twice daily for a total daily dose of 40 mg/kg and 30 mg/kg, respectively. Physical examination, pneumatic otoscopy and tympanogram were performed to evaluate efficacy to therapy. Therapeutic equivalence was established by ruling out a difference (cefaclor minus cefuroxime axetil) of 15% in percentages of clinical success (cure plus improvement). Safety evaluation was performed by assessment of clinical adverse events. In the intent-to-treat analysis post-therapy (1-6 days after completion of therapy), 96 of 104 (92.3%) cefaclor-treated patients had clinical success compared to 90 of 101 (89.1%) cefuroxime axetil patients. The 95% confidence limits on the difference between proportions of favorable outcomes (cefaclor minus cefuroxime axetil) was from -4.8% to +11.2%. At termination of the study (day 10-16 after completion of therapy), 86 of 104 (82.7%) cefaclor patients and 84 of 101 (83.2%) cefuroxime axetil patients had favorable clinical outcomes (95% confidence interval: -10.8% to +9.9%). Thirty-two (30.8%) of the 104 patients in the cefaclor treatment group reported at least one adverse event, with rhinitis reported in 9 (8.7%) patients and cough increased in 7 (6.7%) patients. Thirty-six (35.6%) of the 101 patients in the cefuroxime axetil treatment group reported at least one event, with diarrhea reported in 11 (10.9%) of patients and rhinitis in 10 (9.9%) patients. Cefaclor and cefuroxime axetil were equally effective in the treatment of patients with acute otitis media with effusion who had failed therapy with amoxicillin. Significantly fewer patients treated with cefaclor reported diarrhea, which is the most frequently reported adverse event in children treated with antibiotics for this disease.

Topics: Administration, Oral; Amoxicillin; Cefaclor; Cefuroxime; Cephalosporins; Child, Preschool; Female; Humans; Male; Otitis Media with Effusion; Penicillin Resistance; Penicillins; Single-Blind Method; Treatment Outcome

Two hundred sixty-three pediatric patients from the ages of 3 months to 11 years were enrolled in a randomized, investigator-blinded, multicenter study comparing the clinical and bacteriological efficacies and safety of cefuroxime axetil suspension (CAE) with those of amoxicillin-clavulanate suspension (AMX-CL) in the treatment of acute otitis media with effusion. Patients received CAE at 30 mg/kg of body weight per day (n = 165) in two divided doses or AMX-CL at 40 mg/kg/day (n = 98) in three divided doses for 10 days. The primary pathogens among 200 isolates from pretreatment cultures of middle ear fluid were identified as follows: Haemophilus influenzae (39%), over a third of which were beta-lactamase positive; Streptococcus pneumoniae (34%); and Moraxella catarrhalis (16%). Pathogens were eradicated or presumed to be eradicated from 81% (95 of 118) and 76% (50 of 66) of bacteriologically evaluable patients in the CAE and AMX-CL groups, respectively. A satisfactory clinical response (cure or improvement with or without resolution of effusion) occurred in 113 (77%) of 146 clinically evaluable patients in the CAE group and in 66 (74%) of 89 evaluable patients in the AMX-CL group. Clinical failure or recurrence (within 2 weeks following the completion of treatment) occurred in 22 and 26% of CAE- and AMX-CL-treated patients, respectively. Drug-related adverse events occurred in 18% of CAE-treated patients, whereas they occurred in 39% of AMX-CL-treated patients (P < 0.001); diarrhea or loose stools was the most commonly reported adverse event (CAE, 12%; AMX-CL, 31%; P < 0.001). These results indicate that CAE given twice daily is as effective as AMX-CL given three times daily in the treatment of acute otitis media with effusion in pediatric patients, but CAE was associated with significantly fewer drug-related adverse events.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefuroxime; Child; Child, Preschool; Clavulanic Acids; Female; Humans; Infant; Male; Otitis Media with Effusion; Prodrugs; Suspensions

Cefuroxime axetil was evaluated for clinical efficacy and tolerance in the treatment of acute otitis media in children. Fifty-five children, 5.0 to 10.8 years, were randomly assigned to receive 250mg cefuroxime axetil every 12 hours or 50mg/kg/day amoxicillin in three divided doses. Both treatment schemes lasted for 10 days. Acute otitis media was diagnosed by the presence of erythema and/or opacity with bulging of the tympanic membrane. A tympanogram was obtained upon enrollment to the study, as well as within 2 days after completion of therapy. Fifty-one children completed the treatment protocol. The cure rate was 74.1% for cefuroxime axetil and 75.0% for amoxicillin. Clinical improvement was noted in 25.9% of children treated with cefuroxime axetil and in 25.0% of those treated with amoxicillin. There was no clinical failure in the two treatment groups. None of the children experienced relapse of acute otitis media during the month following completion of therapy. The findings indicate that cefuroxime axetil given twice daily has comparable efficacy to amoxicillin given three times daily in the treatment of children with acute otitis media.

Topics: Acute Disease; Amoxicillin; Cefuroxime; Child; Child, Preschool; Female; Humans; Male; Otitis Media; Otitis Media with Effusion; Prodrugs; Prospective Studies

Cefuroxime axetil and cefaclor were compared for efficacy in the treatment of acute otitis media with effusion. Sixty-four pediatric outpatients had tympanocentesis for culture, and then were randomized to a ten-day course of treatment with cefuroxime axetil or cefaclor. Streptococcus pneumoniae and Haemophilus influenzae were isolated from 25 (39%) and 23 (36%) patients, respectively. Treatment was beneficial in 26 (90%) of the patients who received cefuroxime axetil, and in 16 (76%) of the cefaclor-treated patients. Treatment failed in five (24%) of the cefaclor-treated patients, and in only three (10%) patients who received cefuroxime axetil. Haemophilus influenzae was the initial causative pathogen in a disproportionate number of treatment failures. This study demonstrates the efficacy of cefuroxime axetil in the treatment of otitis media.

Topics: Acute Disease; Cefaclor; Cefuroxime; Cephalosporins; Child; Child, Preschool; Clinical Trials as Topic; Drug Administration Schedule; Drug Evaluation; Female; Humans; Infant; Male; Otitis Media with Effusion; Pharmaceutical Preparations; Prodrugs; Random Allocation

Antimicrobial agents play an important role in the treatment of patients with acute otitis media and otitis media with effusion (OME). The study was undertaken to determine the concentrations of cefuroxime in the blood and middle ear effusions (MEE) of children between 6 and 12 years of age with acute otitis media and chronic OME after a single oral dose administration of cefuroxime axetil, the ester prodrug of cefuroxime. Cefuroxime axetil (250 mg) was administered 2 to 6 hours before either myringotomy for acute otitis media or myringotomy and tube insertion for chronic OME. Blood samples and middle ear aspirates were obtained from 31 children and the samples were analyzed by high performance liquid chromatography. Cefuroxime was recovered in measurable concentrations in all serum samples and in 15 (79%) of the 19 MEE specimens analyzed. No correlation was seen between cefuroxime MEE concentrations and effusion type, bacteriology or serum concentrations. This study shows that cefuroxime does penetrate into MEE when OME is present and that therapeutic concentrations can be achieved in some patients.

Topics: Acute Disease; Administration, Oral; Cefuroxime; Child; Chronic Disease; Exudates and Transudates; Female; Humans; Male; Otitis Media; Otitis Media with Effusion; Prodrugs