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

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ClinicalTrials.gov Identifier: NCT00354952
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : July 20, 2006
Sponsor:
Collaborator:
Abbott
Information provided by:
Universiteit Antwerpen

Tracking Information
First Submitted Date  ICMJE July 19, 2006
First Posted Date  ICMJE July 20, 2006
Last Update Posted Date July 20, 2006
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
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
 (submitted: July 19, 2006)
Variations in the carriage of macrolide-resistance genes due to macrolide exposure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Macrolides (azithromycin or clarithromycin)
Study Arms  ICMJE Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 19, 2006)
203
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2003
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354952
Other Study ID Numbers  ICMJE UA-Med Micro-2002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Universiteit Antwerpen
Collaborators  ICMJE Abbott
Investigators  ICMJE
Principal Investigator: Herman Goossens, MD, PhD Universiteit Antwerpen
PRS Account Universiteit Antwerpen
Verification Date November 2003

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