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ISRCTN
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ISRCTN26642689
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ClinicalTrials.gov identifier
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Public title
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Impact of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci among healthy volunteers: a randomised, double-blind, placebo-controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To assess the direct impact of antibiotic use at the individual level.
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Lay summary
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Ethics approval
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Approved by the Medical Ethics Committee at the University Hospital of Antwerp, Belgium (reference: 2/29/106).
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Study design
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Randomised double-blind placebo-controlled trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Pharyngeal carriage of macrolide-resistant streptococci
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Participants - inclusion criteria
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Healthy adults (18 years of age or older, non-pregnant, free of any respiratory tract infection and not having been administered any antibiotic at least in the past three months) were recruited after informed consent.
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Participants - exclusion criteria
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1. Less than 18 years
2. Having a respiratory infection
3. Having taken an antibiotic course in the previous three months
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Anticipated start date
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01/07/2002
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Anticipated end date
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30/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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203
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Interventions
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Volunteers were administered either azithromycin (500 mg) once daily for three days, clarithromycin (500 mg) twice daily for seven days, or a placebo.
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Primary outcome measure(s)
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Changes in proportions of Macrolide-Resistant Streptococcal (MRS) carriage in the oropharynx.
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Secondary outcome measure(s)
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Variations in the oropharyngeal carriage of macrolide-resistance genes due to macrolide exposure.
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Sources of funding
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Abbott Pharmaceuticals (Belgium)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17292768
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Contact name
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Prof
Herman
Goossens
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Address
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Dept. of Medical Microbiology
S3.14
Universiteitsplein-1
Campus Drie Eiken
University of Antwerp
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City/town
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Antwerp
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Zip/Postcode
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B-2610
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Country
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Belgium
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Sponsor
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Abbott Pharmaceuticals (Belgium)
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Address
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ABBOTT s.a./n.v.
Parc Scientifique
Rue du Bosquet 2
Ottignies
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City/town
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Louvain-La-Neuve
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Zip/Postcode
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B-1348
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Country
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Belgium
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Date applied
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18/07/2006
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Last edited
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25/09/2009
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Date ISRCTN assigned
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04/09/2006
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