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

Pediatr Infect Dis J. 1996 Sep;15(9 Suppl):S10-4. doi: 10.1097/00006454-199609009-00002.

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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Acute Disease
  • Adolescent
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Azithromycin / administration & dosage
  • Azithromycin / 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*
  • Otitis Media / microbiology
  • Pneumococcal Infections / drug therapy

Substances

  • Anti-Bacterial Agents
  • Azithromycin