Microbiological efficacy of 3-day treatment with azithromycin 1.5% eye-drops for purulent bacterial conjunctivitis.

Abstract

PURPOSE:

Antibacterial efficacy of topically applied azithromycin 1.5% was compared with tobramycin 0.3% in a multicenter, randomized, investigator-masked study for the treatment of purulent bacterial conjunctivitis.

METHODS:

A total of 1043 adults and children received either azithromycin twice daily for 3 days (n=524) or tobramycin every 2 hours while awake for 2 days, then four times daily for 5 days (n=519). Conjunctival swabbing was taken at days 0, 3, and 9, using alginate swabs resuspended in a dissolution-transport medium, providing rapid and reproducible results. Cagle's criteria were used to define the pathogenicity level for each isolated bacterium.

RESULTS:

In the per-protocol set, the rate of bacteriologic resolution was 85.2% for azithromycin versus 83.8% for tobramycin on day 3, and 92.8% for azithromycin versus 94.6% for tobramycin on day 9. Azithromycin was demonstrated to be noninferior to tobramycin according to the 10% noninferiority margin. Although some bacteria were categorized as resistant to tested antibiotics, eradication was observed (for azithromycin: Acinetobacter, Enterobacteriaceae, Pseudomonas), highlighting the specific pharmacokinetics/pharmacodynamics of the ocular route.

CONCLUSIONS:

In total, topical therapy with azithromycin 1.5% administered only twice daily for 3 days effectively eradicates most pathogenic bacteria associated with bacterial conjunctivitis. These microbiologic results are in accordance with the observed clinical outcome. This new anti-infective product has the advantage of a short treatment course which could lead to an improvement in patient compliance.

• Authors: F Denis, C Chaumeil, P Goldschmidt, L Delval, P Pouliquen, I Cochereau, D Chainier, B De Barbeyrac
• Journal: European journal of ophthalmology (Eur J Ophthalmol) 2008 Nov-Dec Vol. 18 Issue 6 Pg. 858-68 ISSN: 1120-6721 [Print] United States
• PMID: 18988154 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Ophthalmic Solutions
• Azithromycin
• Tobramycin

Topics

• Administration, Topical
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Azithromycin (administration & dosage, therapeutic use)
• Bacteria (drug effects, isolation & purification)
• Child
• Child, Preschool
• Conjunctiva (microbiology)
• Conjunctivitis, Bacterial (drug therapy, microbiology)
• Double-Blind Method
• Drug Resistance, Bacterial
• Female
• Humans
• Infant
• Infant, Newborn
• Male
• Microbial Sensitivity Tests
• Middle Aged
• Ophthalmic Solutions (administration & dosage, therapeutic use)
• Time Factors
• Tobramycin (administration & dosage, therapeutic use)
• Young Adult