Impact of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci among healthy volunteers: a randomised, double-blind, placebo-controlled trial

ISRCTN	ISRCTN26642689
DOI	https://doi.org/10.1186/ISRCTN26642689
Protocol serial number	N/A
Sponsor	Abbott Pharmaceuticals (Belgium)
Funder	Abbott Pharmaceuticals (Belgium)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Herman Goossens
Scientific

Dept. of Medical Microbiology
S3.14
Universiteitsplein-1
Campus Drie Eiken
University of Antwerp
Antwerp
B-2610
Belgium

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To assess the direct impact of antibiotic use at the individual level.
Ethics approval(s)	Approved by the Medical Ethics Committee at the University Hospital of Antwerp, Belgium (reference: 2/29/106).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Azithromycin and clarithromycin
Primary outcome measure(s)	Changes in proportions of Macrolide-Resistant Streptococcal (MRS) carriage in the oropharynx.
Key secondary outcome measure(s)	Variations in the oropharyngeal carriage of macrolide-resistance genes due to macrolide exposure.
Completion date	30/10/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	203
Key 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.
Key exclusion criteria	1. Less than 18 years 2. Having a respiratory infection 3. Having taken an antibiotic course in the previous three months
Date of first enrolment	01/07/2002
Date of final enrolment	30/10/2003

Dept. of Medical Microbiology

Antwerp
B-2610
Belgium

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/02/2007		Yes	No