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Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

NCT ID: NCT00190151

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-07-31

Brief Summary

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Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

Detailed Description

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Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

Conditions

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Healthy Volunteers

Keywords

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ciprofloxacin commensal flora resistance Pharmacokinetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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ciprofloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpement

Principal Investigators

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Bruno Fantin

Role: STUDY_CHAIR

Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, France

Xavier Duval

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat Claude Bernard, 48 rue Henri Huchard, 75877 Paris Cedex 18, France

Locations

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Hôpital Bichat Claude Bernard, 46 rue Henri Huchard

Paris, , France

Site Status

Countries

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France

References

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de Lastours V, Maugy E, Mathy V, Chau F, Rossi B, Guerin F, Cattoir V, Fantin B; CIPHARES Study Group. Ecological impact of ciprofloxacin on commensal enterococci in healthy volunteers. J Antimicrob Chemother. 2017 Jun 1;72(6):1574-1580. doi: 10.1093/jac/dkx043.

Reference Type DERIVED
PMID: 28333351 (View on PubMed)

de Lastours V, Cambau E, Guillard T, Marcade G, Chau F, Fantin B. Diversity of individual dynamic patterns of emergence of resistance to quinolones in Escherichia coli from the fecal flora of healthy volunteers exposed to ciprofloxacin. J Infect Dis. 2012 Nov;206(9):1399-406. doi: 10.1093/infdis/jis511. Epub 2012 Aug 28.

Reference Type DERIVED
PMID: 22930806 (View on PubMed)

Fantin B, Duval X, Massias L, Alavoine L, Chau F, Retout S, Andremont A, Mentre F. Ciprofloxacin dosage and emergence of resistance in human commensal bacteria. J Infect Dis. 2009 Aug 1;200(3):390-8. doi: 10.1086/600122.

Reference Type DERIVED
PMID: 19563257 (View on PubMed)

Other Identifiers

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P031007

Identifier Type: -

Identifier Source: org_study_id