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Completed

NCT Number: NCT00354952

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Depatment of Medical Microbiology, Universiteit Antwerpen

Antwerp, B-2610, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macrolides (azithromycin or clarithromycin)

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Abbott

Registry information

Official study title

Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2002
Study completion
2003
First posted
Jul 20, 2006
Registry last updated
Jul 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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