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


CONCLUSIONS
Azithromycin is an effective, safe and well-tolerated treatment for children with acute otitis media.
McCarty
J
J
California Medical Research Group, Fresno, USA.
D000208:Acute Disease; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006192:Haemophilus Infections / Q000188:drug therapy; D006801:Humans; D008297:Male; D001936:Moraxella catarrhalis; D016870:Neisseriaceae Infections / Q000188:drug therapy; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D011008:Pneumococcal Infections / Q000188:drug therapy
D000900:Anti-Bacterial Agents; D017963:Azithromycin