NCT00354952

Brief Summary

Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2002

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
Last Updated

July 20, 2006

Status Verified

November 1, 2003

First QC Date

July 19, 2006

Last Update Submit

July 19, 2006

Conditions

Healthy Volunteers

Keywords

Healthy volunteersAntibiotic exposureResistance selection

Outcome Measures

Primary Outcomes (1)

  • Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Secondary Outcomes (1)

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

Interventions

Macrolides (azithromycin or clarithromycin)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults (≥ 18 years of age)
  • non-pregnant
  • free of any respiratory tract infection
  • not having been administered any antibiotic at least in the past three months

You may not qualify if:

  • \<18 years of age
  • pregnant
  • having a respiratory tract infection
  • having been administered any antibiotic at least in the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depatment of Medical Microbiology, Universiteit Antwerpen

Antwerp, Antwerp, B-2610, Belgium

Location

Related Publications (1)

  • 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 Feb 10;369(9560):482-90. doi: 10.1016/S0140-6736(07)60235-9.

    PMID: 17292768DERIVED

MeSH Terms

Interventions

MacrolidesAzithromycinClarithromycin

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic CompoundsErythromycin

Study Officials

  • Herman Goossens, MD, PhD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

July 1, 2002

Study Completion

October 1, 2003

Last Updated

July 20, 2006

Record last verified: 2003-11

Locations

BE(1)