Condition category
Infections and Infestations
Date applied
18/07/2006
Date assigned
04/09/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Herman Goossens

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Abbott Pharmaceuticals (Belgium)

Sponsor details

ABBOTT s.a./n.v.
Parc Scientifique
Rue du Bosquet 2
Ottignies
Louvain-La-Neuve
B-1348
Belgium

Sponsor type

Industry

Website

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

  1. 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.

Additional files

Editorial Notes