ColonizationNCT00520715
Epidemiology of Fluoroquinolone Resistance in Human Commensal Flora in Patients Hospitalised in Medical Wards
An observational study of Colonization and Multi Drug Resistant Bacteria, run by Association Pour le Recherche en Infectiologie et en Médecine Interne at 1 site in France.
Trial summary
Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonization, Multi Drug Resistant Bacteria, Hospitalized Patients
- How many people
- 640 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Dec 2007
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adults patients at hospital admission hospital stay >24 hours informed consent required
Who may be able to join
- all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France.
- patient agreement
Who cannot join
- Age < 18
- patient refusal or incapable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards
Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.
- Keywords
- fluoroquinolone resistance, commensal flora, carriage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients at hospital admission | Patients at hospital admission in medical wards on our tertiray care hospital (Hôpital Beaujon, Clichy, France). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonizationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour le Recherche en Infectiologie et en Médecine Interne
- Sponsor type
- University, hospital or other
- Collaborators
- Pr Bruno Fantin
- Responsible party
- Principal investigator, Dr Victoire de Lastours, Association Pour le Recherche en Infectiologie et en Médecine Interne
- Investigators
- Victoire de Lastours, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520715
- Sponsor's protocol ID
- FQ/EPI
- Status last verified
- Jun 2015
- First submitted
- 11 Jul 2007
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
de Lastours V, Chau F, Tubach F, Pasquet B, Ruppe E, Fantin B. Independent behavior of commensal flora for carriage of fluoroquinolone-resistant bacteria in patients at admission. Antimicrob Agents Chemother. 2010 Dec;54(12):5193-200. doi: 10.1128/AAC.00823-10. Epub 2010 Sep 27.
PubMed 20876373
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards
- ClinicalTrials.gov ID
- NCT00520715
- Acronym / sponsor ID
- FQ/EPI
- Keywords
- fluoroquinolone resistance, commensal flora, carriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Association Pour le Recherche en Infectiologie et en Médecine InterneUniversity, hospital or other
- Collaborators
- Pr Bruno Fantin
- Study start
- Jun 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Aug 2007 (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.
Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at hospital admission | – | –Patients at hospital admission in medical wards on our tertiray care hospital (Hôpital Beaujon, Clichy, France). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults patients at hospital admission hospital stay >24 hours informed consent required
Key inclusion criteria (2 listed)
- all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France.
- patient agreement
Key exclusion criteria (2 listed)
- Age < 18
- patient refusal or incapable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Derived from this study: PubMed 20876373de Lastours V, Chau F, Tubach F, Pasquet B, Ruppe E, Fantin B. Independent behavior of commensal flora for carriage of fluoroquinolone-resistant bacteria in patients at admission. Antimicrob Agents Chemother. 2010 Dec;54(12):5193-200. doi: 10.1128/AAC.00823-10. Epub 2010 Sep 27.
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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.
Victoire de Lastours, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonization and Multi Drug Resistant Bacteria, run by Association Pour le Recherche en Infectiologie et en Médecine Interne 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jun 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00520715, which also lists 1 linked publication.
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 23 Jun 2015.