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

Healthy Volunteers Clinical Trial

Official title:

Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354952
• Other study ID #: UA-Med Micro-2002
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: July 19, 2006
• Start date: July 2002
• Est. completion date: October 2003

Study information

• Verified date: November 2003
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Macrolides (azithromycin or clarithromycin)

Locations

Country	Name	City	State
Belgium	Depatment of Medical Microbiology, Universiteit Antwerpen	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Abbott

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
Secondary	Variations in the carriage of macrolide-resistance genes due to macrolide exposure.