Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To assess the direct impact of antibiotic use at the individual level.
Ethics approval
Approved by the Medical Ethics Committee at the University Hospital of Antwerp, Belgium (reference: 2/29/106).
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pharyngeal carriage of macrolide-resistant streptococci
Intervention
Volunteers were administered either azithromycin (500 mg) once daily for three days, clarithromycin (500 mg) twice daily for seven days, or a placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Azithromycin and clarithromycin
Primary outcome measures
Changes in proportions of Macrolide-Resistant Streptococcal (MRS) carriage in the oropharynx.
Secondary outcome measures
Variations in the oropharyngeal carriage of macrolide-resistance genes due to macrolide exposure.
Overall trial start date
01/07/2002
Overall trial end date
30/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
203
Participant exclusion criteria
1. Less than 18 years
2. Having a respiratory infection
3. Having taken an antibiotic course in the previous three months
Recruitment start date
01/07/2002
Recruitment end date
30/10/2003
Locations
Countries of recruitment
Belgium
Trial participating centre
Dept. of Medical Microbiology
Antwerp
B-2610
Belgium
Funders
Funder type
Industry
Funder name
Abbott Pharmaceuticals (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17292768
Publication citations
-
Results
Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H, Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study., Lancet, 2007, 369, 9560, 482-490, doi: 10.1016/S0140-6736(07)60235-9.