Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT00354952
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.

Detailed Description

Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level. 203 healthy cohorts were treated with azithromycin, clarithromycin, or a placebo in a randomised, double-blind trial. Pharyngeal swabs were collected pre- (day 0) and post-antibiotic administration (days 8, 14, 28, 42, 180) and proportions of macrolide-resistant streptococci (MRS) were determined at each time-point.

Study Timeline

• Study Start: 2002-07
• Study Completion: 2003-10
• Status Verified: 2003-11
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Last Update Submitted: 2006-07-19
• Study First Posted: 2006-07-20
• Last Update Posted: 2006-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• healthy adults (≥ 18 years of age)
• non-pregnant
• free of any respiratory tract infection
• not having been administered any antibiotic at least in the past three months

Exclusion Criteria

• <18 years of age
• pregnant
• having a respiratory tract infection
• having been administered any antibiotic at least in the past three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Secondary Outcome Measures

Name	Time	Method
Variations in the carriage of macrolide-resistance genes due to macrolide exposure.

Trial Locations

Locations (1)

Depatment of Medical Microbiology, Universiteit Antwerpen; 🇧🇪 Antwerp, Belgium