Healthy VolunteersNCT00190151
Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
A study testing ciprofloxacin in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ciprofloxacin
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Healthy Volunteers
- Being tested
- ciprofloxacin
- Keywords
- ciprofloxacin, commensal flora, resistance, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of bacterial resistance in commensal flora
Secondary outcomes (1)
Pharmacokinetic/pharmacodynamic relationship
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2005
- Study completionJul 2005
Why it stopped: terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Fantin, Study chair, Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, FranceXavier Duval, Principal investigator, Hôpital Bichat Claude Bernard, 48 rue Henri Huchard, 75877 Paris Cedex 18, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190151
- Sponsor's protocol ID
- P031007
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
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 28333351de 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 22930806Fantin 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
- ClinicalTrials.gov ID
- NCT00190151
- Acronym / sponsor ID
- P031007
- Conditions
- Healthy Volunteers
- Keywords
- ciprofloxacin, commensal flora, resistance, Pharmacokinetic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofloxacin | Drug | – |
Primary outcome
Occurrence of bacterial resistance in commensal flora
1 secondary outcome
Pharmacokinetic/pharmacodynamic relationship
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Derived from this study: PubMed 28333351de 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.
- Derived from this study: PubMed 22930806de 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.
- Derived from this study: PubMed 19563257Fantin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofloxacin in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of bacterial resistance in commensal flora. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00190151, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.