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

Tracking Information

First Received Date ^ICMJE

July 19, 2006

Last Updated Date

July 19, 2006

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: Macrolides (azithromycin or clarithromycin)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

203

Completion Date

October 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00354952

Responsible Party

Study ID Numbers ^ICMJE

UA-Med Micro-2002

Study Sponsor ^ICMJE

Universiteit Antwerpen

Collaborators ^ICMJE

Abbott

Investigators ^ICMJE

Principal Investigator:

Herman Goossens, MD, PhD

Universiteit Antwerpen

Information Provided By

Universiteit Antwerpen

Verification Date

November 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP