Viewing Study NCT00354952



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Study NCT ID: NCT00354952
Status: COMPLETED
Last Update Posted: 2006-07-20
First Post: 2006-07-19

Brief Title: Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
Sponsor: Universiteit Antwerpen
Organization: Universiteit Antwerpen

Study Overview

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
Status: COMPLETED
Status Verified Date: 2003-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None