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Continuous twice daily or once daily amoxicillin prophylaxis compared with placebo for children with recurrent acute
1Department of Pediatrics, University of Colorado School of Medicine, Denver, USA.
Insights
Amoxicillin prophylaxis did not prevent new acute otitis media (AOM) episodes, with no difference between once-daily or twice-daily dosing versus placebo. Routine amoxicillin use for AOM prevention is discouraged due to lack of effectiveness and risk of antibiotic resistance.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Recurrent acute otitis media (AOM) is a common childhood illness.
- Antibiotic prophylaxis is sometimes used to prevent AOM, but its effectiveness and optimal dosing are debated.
Purpose of the Study:
- To compare the efficacy of continuous amoxicillin administration, given once daily (qd) or twice daily (bid), versus placebo in preventing new episodes of AOM in children.
- To evaluate the impact of dosing frequency on amoxicillin's prophylactic effect against AOM.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted with 158 children aged 3 months to 6 years with a history of recurrent AOM.
- Participants received either amoxicillin (20 mg/kg/day) bid, amoxicillin qd, or placebo qd.
- Children were monitored monthly and for symptoms of upper respiratory infections, with study termination upon development of two new AOM episodes.
Main Results:
- The incidence density (ID) of new AOM episodes was similar across all three groups (amoxicillin qd, amoxicillin bid, and placebo).
- The proportion of children remaining otitis-free was comparable: 63% for placebo, 64% for once-daily amoxicillin, and 61% for twice-daily amoxicillin.
- No significant differences in AOM incidence were observed when stratified by age or season.
Conclusions:
- Amoxicillin prophylaxis, whether administered once or twice daily, demonstrated no significant benefit over placebo in preventing new AOM episodes.
- The study suggests discouraging routine amoxicillin prophylaxis for AOM due to its lack of effectiveness and the potential to promote antibiotic resistance.
- Findings highlight the need for careful consideration of antibiotic use in managing recurrent AOM.
Objective:
To determine the effectiveness of amoxicillin administered continuously twice daily vs. once daily vs. placebo to prevent new episodes of acute otitis media (AOM).
Design:
Randomized, double blind, placebo-controlled clinical trial at a hospital-based general pediatric clinic and a private pediatric practice, both in Denver, CO.
Participants:
One hundred ninety-four children (age 3 months through 6 years) were enrolled with 3 documented AOM episodes within the prior 6 months, without ventilating tubes or associated anatomic defects, immunodeficiency disorders or allergy to penicillin. Thirty-six were noncompliant and were excluded from the study, leaving 158 evaluable subjects.
Interventions:
The amoxicillin dosage was 20 mg/kg/day either bid or qd. After randomization to placebo twice daily (bid), amoxicillin once daily (qd)/placebo qd or amoxicillin bid, patients were followed monthly and were also seen for upper respiratory infection symptoms during enrollment in the trial. Development of two new AOM episodes terminated the patients from the study.
Measurements/Main Results:
Incidence density (ID) measurements were calculated for all study subjects and were stratified by age and season. Overall study subjects in all 3 arms of the trial had 7243 days at risk during which time they developed 56 new AOM episodes for a annual ID of 2.82. There were no significant differences in the IDs between amoxicillin qd vs. bid or amoxicillin (bid or qd) vs. placebo. After stratifying by age and season of enrollment, there were no significant differences in ID rates among the 3 groups. The proportion of subjects remaining otitis-free was 63% for the placebo group, 64% for once daily amoxicillin and 61% for twice daily amoxicillin.
Conclusion:
While once-a-day dosing was equivalent to twice-a-day dosing for amoxicillin prophylaxis, there was no benefit of amoxicillin prophylaxis compared with a placebo control in preventing new AOM episodes. Because of the potential of excessive antibiotic use to promote the acquisition of resistant pneumococci and the lack of effectiveness in this trial, routine use of amoxicillin prophylaxis should be discouraged.