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TerminatedNCT00190151Updated Sep 18, 2012

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

An interventional study of ciprofloxacin in Healthy Volunteers, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-18.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Why this study was terminated
terminated
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • ciprofloxacin
  • commensal flora
  • resistance
  • Pharmacokinetic
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
48 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Occurrence of bacterial resistance in commensal flora

Secondary outcomes

  1. Pharmacokinetic/pharmacodynamic relationship

07

Study locations

1 site
  • Hôpital Bichat Claude Bernard, 46 rue Henri Huchard
    Paris, 75877, France
08

References and documents

Publications

  • 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. PubMed 28333351 ↗
  • 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. PubMed 22930806 ↗
  • 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. PubMed 19563257 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00190151
Lead sponsor
Assistance Publique - Hôpitaux de Paris
First posted
Sep 19, 2005
Start date
Sep 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Sep 18, 2012

Study contacts

Bruno Fantin
study chair · Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, France
Xavier Duval
principal investigator · Hôpital Bichat Claude Bernard, 48 rue Henri Huchard, 75877 Paris Cedex 18, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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