Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
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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 |
- Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
- 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 |
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 |
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| Belgium | |
| Depatment of Medical Microbiology, Universiteit Antwerpen | |
| Antwerp, Belgium, B-2610 | |
| 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 May 23, 2013