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Randomized, open label, multicenter trial of cefixime compared with amoxicillin for treatment of acute otitis media
1Scottsdale Pediatric Center, AZ.
Insights
Cefixime offers a safe and effective treatment for acute otitis media with effusion in children, comparable to amoxicillin. Its once-daily dosing may improve adherence and convenience for pediatric patients.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Acute otitis media with effusion (AOME) is a common pediatric condition requiring effective antibiotic treatment.
- Current treatment guidelines often involve amoxicillin, but adherence can be challenging due to multiple daily doses.
Purpose of the Study:
- To evaluate the safety and efficacy of cefixime, a third-generation cephalosporin, for treating AOME in children.
- To compare cefixime's efficacy and safety profile against amoxicillin in a pediatric population.
Main Methods:
- A multicenter, randomized clinical trial involving 120 children with AOME.
- Patients received either a 10-day course of cefixime (8 mg/kg daily) or amoxicillin (40 mg/kg/day in three divided doses).
- Tympanocentesis was performed pre-therapy for pathogen identification; efficacy was assessed based on clinical response and bacteriologic eradication.
Main Results:
- High clinical cure/improvement rates were observed: 93% for cefixime and 94% for amoxicillin.
- Bacteriologic eradication rates were also comparable: 94% for cefixime and 95% for amoxicillin.
- Cefixime showed a higher incidence of gastrointestinal disturbances (22%) and rash (15%) compared to amoxicillin (8% and 2%, respectively), but rarely necessitated treatment discontinuation.
Conclusions:
- Once-daily cefixime is a safe and effective alternative to amoxicillin for treating pediatric AOME.
- Cefixime's once-daily dosing regimen presents a potential advantage for improving patient adherence and simplifying treatment.
Abstract:
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.