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A multicenter, open label trial of azithromycin vs. amoxicillin/ clavulanate for the management of acute otitis media in children.
Pediatr Infect Dis J 1996; 15(9 Suppl):S15-9PI

Abstract

OBJECTIVE

This randomized, open label study compared the efficacy and safety of a 5-day course of once daily azithromycin to those of a 10-day course of three times daily amoxicillin/ clavulanate.

METHODS

One hundred sixty-nine children with confirmed acute bacterial otitis media were randomized to treatment with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days or 40 mg/kg/ day of amoxicillin/clavulanate suspension in three divided doses for 10 days. Clinical efficacy and safety were evaluated on Days 11 and 30.

RESULTS

Analysis of evaluable patients 11 days after the start of treatment demonstrated that 87.8% of patients treated with azithromycin and 100.0% of the patients treated with amoxicillin/ clavulanate were cured or improved. Presumed bacteriologic eradication of the baseline pathogens Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes was comparable in the two groups: 87.8% in patients treated with azithromycin; and 100.0% in patients receiving amoxicillin/clavulanate. At Day 30, 82.2% of patients treated with azithromycin and 80.0% of patients treated with amoxicillin/clavulanate were cured or improved. Presumed bacteriologic eradication of the base-line pathogens was similar in the two groups: 82.2% in patients treated with azithromycin; and 81.1% in patients receiving amoxicillin/clavulanate. Relapses occurred in 5.1% of patients receiving azithromycin and 21.1% of patients taking amoxicillin/clavulanate (P = 0.047). Treatment-related side effects occurred in 3.5% of the azithromycin patients compared with 31.0% of amoxicillin/clavulanate patients (P < 0.001).

CONCLUSIONS

Azithromycin was comparable to amoxicillin/clavulanate in achieving clinical cure or improvement and presumed eradication of baseline pathogens in pediatric patients with acute otitis media. Azithromycin was significantly better tolerated and was associated with fewer relapses than seen after amoxicillin/clavulanate therapy.

Authors+Show Affiliations

Department of Pediatrics, Emory Medical School, Atlanta, GA, USA.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8878241

Citation

Aronovitz, G. "A Multicenter, Open Label Trial of Azithromycin Vs. Amoxicillin/ Clavulanate for the Management of Acute Otitis Media in Children." The Pediatric Infectious Disease Journal, vol. 15, no. 9 Suppl, 1996, pp. S15-9.
Aronovitz G. A multicenter, open label trial of azithromycin vs. amoxicillin/ clavulanate for the management of acute otitis media in children. Pediatr Infect Dis J. 1996;15(9 Suppl):S15-9.
Aronovitz, G. (1996). A multicenter, open label trial of azithromycin vs. amoxicillin/ clavulanate for the management of acute otitis media in children. The Pediatric Infectious Disease Journal, 15(9 Suppl), pp. S15-9.
Aronovitz G. A Multicenter, Open Label Trial of Azithromycin Vs. Amoxicillin/ Clavulanate for the Management of Acute Otitis Media in Children. Pediatr Infect Dis J. 1996;15(9 Suppl):S15-9. PubMed PMID: 8878241.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, open label trial of azithromycin vs. amoxicillin/ clavulanate for the management of acute otitis media in children. A1 - Aronovitz,G, PY - 1996/9/1/pubmed PY - 1996/9/1/medline PY - 1996/9/1/entrez SP - S15 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 15 IS - 9 Suppl N2 - OBJECTIVE: This randomized, open label study compared the efficacy and safety of a 5-day course of once daily azithromycin to those of a 10-day course of three times daily amoxicillin/ clavulanate. METHODS: One hundred sixty-nine children with confirmed acute bacterial otitis media were randomized to treatment with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days or 40 mg/kg/ day of amoxicillin/clavulanate suspension in three divided doses for 10 days. Clinical efficacy and safety were evaluated on Days 11 and 30. RESULTS: Analysis of evaluable patients 11 days after the start of treatment demonstrated that 87.8% of patients treated with azithromycin and 100.0% of the patients treated with amoxicillin/ clavulanate were cured or improved. Presumed bacteriologic eradication of the baseline pathogens Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes was comparable in the two groups: 87.8% in patients treated with azithromycin; and 100.0% in patients receiving amoxicillin/clavulanate. At Day 30, 82.2% of patients treated with azithromycin and 80.0% of patients treated with amoxicillin/clavulanate were cured or improved. Presumed bacteriologic eradication of the base-line pathogens was similar in the two groups: 82.2% in patients treated with azithromycin; and 81.1% in patients receiving amoxicillin/clavulanate. Relapses occurred in 5.1% of patients receiving azithromycin and 21.1% of patients taking amoxicillin/clavulanate (P = 0.047). Treatment-related side effects occurred in 3.5% of the azithromycin patients compared with 31.0% of amoxicillin/clavulanate patients (P < 0.001). CONCLUSIONS: Azithromycin was comparable to amoxicillin/clavulanate in achieving clinical cure or improvement and presumed eradication of baseline pathogens in pediatric patients with acute otitis media. Azithromycin was significantly better tolerated and was associated with fewer relapses than seen after amoxicillin/clavulanate therapy. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/8878241/A_multicenter_open_label_trial_of_azithromycin_vs__amoxicillin/_clavulanate_for_the_management_of_acute_otitis_media_in_children_ L2 - http://Insights.ovid.com/pubmed?pmid=8878241 DB - PRIME DP - Unbound Medicine ER -