Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
Information source: Universiteit Antwerpen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Macrolides (azithromycin or clarithromycin) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Universiteit Antwerpen Official(s) and/or principal investigator(s):
Herman Goossens, MD, PhD, Principal Investigator, Affiliation: Universiteit Antwerpen
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.
Clinical Details
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
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
Secondary outcome: Variations in the carriage of macrolide-resistance genes due to macrolide exposure.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Depatment of Medical Microbiology, Universiteit Antwerpen, Antwerp B-2610, Belgium
Additional Information
Starting date: July 2002
Ending date: October 2003
Last updated: July 19, 2006
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