A multicenter, open label trial of azithromycin for the treatment of children with acute otitis media.

Abstract

OBJECTIVE:

In this multicenter, open label trial the investigators evaluated the efficacy and safety of azithromycin suspension administered once daily for 5 days for the treatment of clinically and bacteriologically established acute otitis media.

METHODS:

Two hundred eligible children with acute otitis media from 10 US centers were treated with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days. Tympanocentesis and subsequent culture of middle ear effusion were performed at baseline. Clinical efficacy was evaluated on Days 6, 11 and 30.

RESULTS:

Analysis of clinical efficacy in evaluable patients 11 days after the initiation of therapy showed that the rate of satisfactory responses (cured or improved) ranged from 79.6 to 82.4% in patients infected with Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. Satisfactory clinical response at Day 30 was reported in 70% of evaluable patients, and eradication of S. pneumoniae, H. influenzae and M. catarrhalis was presumed in 64 to 73%. Relapses occurred in 14% of the evaluable patients. Among the treated patients 8.5% reported mild or moderate side effects.

CONCLUSION:

Azithromycin is an effective, safe and well-tolerated treatment for children with acute otitis media.

• Authors: J McCarty
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 15 Issue 9 Suppl Pg. S10-4 (Sep 1996) ISSN: 0891-3668 [Print] United States
• PMID: 8878240 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Anti-Bacterial Agents
• Azithromycin

Topics

• Acute Disease
• Adolescent
• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Azithromycin (administration & dosage, therapeutic use)
• Child
• Child, Preschool
• Drug Administration Schedule
• Female
• Haemophilus Infections (drug therapy)
• Humans
• Male
• Moraxella catarrhalis
• Neisseriaceae Infections (drug therapy)
• Otitis Media (drug therapy, microbiology)
• Pneumococcal Infections (drug therapy)