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 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/07/2006
- Registration date
- 04/09/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Herman Goossens
Scientific
Scientific
Dept. of Medical Microbiology
S3.14
Universiteitsplein-1
Campus Drie Eiken
University of Antwerp
Antwerp
B-2610
Belgium
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Azithromycin and clarithromycin |
| Primary outcome measure | 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 study start date | 01/07/2002 |
| Completion date | 30/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Dept. of Medical Microbiology
Antwerp
B-2610
Belgium
B-2610
Belgium
Sponsor information
Abbott Pharmaceuticals (Belgium)
Industry
Industry
ABBOTT s.a./n.v.
Parc Scientifique
Rue du Bosquet 2
Ottignies
Louvain-La-Neuve
B-1348
Belgium
"ROR" |
https://ror.org/04x0p4p48 |
|---|
Funders
Funder type
Industry
Abbott Pharmaceuticals (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/02/2007 | Yes | No |
