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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT00354952
First received: July 19, 2006
Last updated: NA
Last verified: November 2003
History: No changes posted

July 19, 2006
July 19, 2006
July 2002
Not Provided
Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
Same as current
No Changes Posted
Variations in the carriage of macrolide-resistance genes due to macrolide exposure.
Same as current
Not Provided
Not Provided
 
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Healthy Volunteers
Drug: Macrolides (azithromycin or clarithromycin)
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
October 2003
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00354952
UA-Med Micro-2002
Not Provided
Not Provided
Universiteit Antwerpen
Abbott
Principal Investigator: Herman Goossens, MD, PhD Universiteit Antwerpen
Universiteit Antwerpen
November 2003

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