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

Sponsors and Collaborators:	Universiteit Antwerpen Abbott
Information provided by:	Universiteit Antwerpen
ClinicalTrials.gov Identifier:	NCT00354952

Purpose

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.

Condition	Intervention
Healthy Volunteers	Drug: Macrolides (azithromycin or clarithromycin)

MedlinePlus related topics: Antibiotics

Drug Information available for: Azithromycin Clarithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	203
Study Start Date:	July 2002
Estimated Study Completion Date:	October 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354952

Locations

Belgium
Depatment of Medical Microbiology, Universiteit Antwerpen
Antwerp, Belgium, B-2610

Sponsors and Collaborators

Universiteit Antwerpen

Abbott

Investigators

Principal Investigator:

Herman Goossens, MD, PhD

Universiteit Antwerpen

More Information

Publications indexed to this study:

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.

Study ID Numbers:	UA-Med Micro-2002
Study First Received:	July 19, 2006
Last Updated:	July 19, 2006
ClinicalTrials.gov Identifier:	NCT00354952
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Universiteit Antwerpen:

Healthy volunteers
Antibiotic exposure
Resistance selection

Study placed in the following topic categories:

Clarithromycin
Azithromycin
Healthy

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009