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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-10-31

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Keywords

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Healthy volunteers Antibiotic exposure Resistance selection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Macrolides (azithromycin or clarithromycin)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Herman Goossens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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Depatment of Medical Microbiology, Universiteit Antwerpen

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H. Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study. Lancet. 2007 Feb 10;369(9560):482-90. doi: 10.1016/S0140-6736(07)60235-9.

Reference Type DERIVED

PMID: 17292768 (View on PubMed)

Other Identifiers

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UA-Med Micro-2002

Identifier Type: -

Identifier Source: org_study_id