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
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Universiteit Antwerpen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00354952     History of Changes
Other Study ID Numbers: UA-Med Micro-2002
Study First Received: July 19, 2006
Last Updated: July 19, 2006
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Universiteit Antwerpen:
Healthy volunteers
Antibiotic exposure
Resistance selection

Additional relevant MeSH terms:
Anti-Bacterial Agents
Azithromycin
Clarithromycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014