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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN26642689
• Date of registration: 04/09/2006
• Primary sponsor: Abbott Pharmaceuticals (Belgium)
• Public title: Impact of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci among healthy volunteers: a randomised, double-blind, placebo-controlled trial N/A
• Date of first enrolment: Jul 1 2002
• Target sample size: 203
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN26642689
• Study type: Interventional
• Study design: Randomised double-blind placebo-controlled trial

Countries of recruitment

Belgium

Contacts

• Name: Herman Goossens

Key inclusion & exclusion criteria

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.
Exclusion criteria: 1. Less than 18 years
2. Having a respiratory infection
3. Having taken an antibiotic course in the previous three months

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Pharyngeal carriage of macrolide-resistant streptococci

Intervention(s)

Volunteers were administered either azithromycin (500 mg) once daily for three days, clarithromycin (500 mg) twice daily for seven days, or a placebo.

Primary Outcome(s)

Changes in proportions of Macrolide-Resistant Streptococcal (MRS) carriage in the oropharynx.

Secondary Outcome(s)

Variations in the oropharyngeal carriage of macrolide-resistance genes due to macrolide exposure.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Abbott Pharmaceuticals (Belgium)

Secondary Sponsor(s)

N/A