Selection of Antibiotic Resistance by Azithromycin and Cl... | NCT00354952

Studies
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora

NCT00354952

Sponsor

Universiteit Antwerpen

Status

Completed

Last Update Posted

Jul 20, 2006Estimated

Enrollment

203

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Macrolides (azithromycin or clarithromycin)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Oct 2003

First Submitted Date

Jul 19, 2006

First Submission Date that Met QC Criteria

Jul 19, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2006

Last Update Posted Date

Jul 20, 2006Estimated

Name	Class
Abbott	INDUSTRY

Description Module

Brief Summary

Detailed Description

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. 203 healthy cohorts were treated with azithromycin, clarithromycin, or a placebo in a randomised, double-blind trial. Pharyngeal swabs were collected pre- (day 0) and post-antibiotic administration (days 8, 14, 28, 42, 180) and proportions of macrolide-resistant streptococci (MRS) were determined at each time-point.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

203

Name	Type	Description	Arm Group Labels	Other Names
Macrolides (azithromycin or clarithromycin)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Secondary Outcomes

Measure	Description	Time Frame
Variations in the carriage of macrolide-resistance genes due to macrolide exposure.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Herman Goossens, MD, PhD	Universiteit Antwerpen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Depatment of Medical Microbiology, Universiteit Antwerpen		Antwerp	Antwerp	B-2610	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17292768	Derived	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.

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D061065	Polyketides
D047028	Macrocyclic Compounds

ID	Term
D018942	Macrolides
D017963	Azithromycin
D017291	Clarithromycin