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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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Macrolides (azithromycin or clarithromycin) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
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 Start Date : July 2002
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Secondary Outcome Measures :
  1. Variations in the carriage of macrolide-resistance genes due to macrolide exposure.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354952


Locations
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Belgium
Depatment of Medical Microbiology, Universiteit Antwerpen
Antwerp, Belgium, B-2610
Sponsors and Collaborators
Universiteit Antwerpen
Abbott
Investigators
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Principal Investigator: Herman Goossens, MD, PhD Universiteit Antwerpen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00354952     History of Changes
Other Study ID Numbers: UA-Med Micro-2002
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: July 20, 2006
Last Verified: November 2003
Keywords provided by Universiteit Antwerpen:
Healthy volunteers
Antibiotic exposure
Resistance selection
Additional relevant MeSH terms:
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Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors