Digestive Colonisation by Highly Resistant Bacteria (CODBAHRE) (CODBAHRE)
Identification of New Highly Antibiotic-resistant Bacteria Carriage Risk Factors to Optimize the Detection and Medical Care for Carriers Patients
Studieoversikt
Status
Forhold
Detaljert beskrivelse
CODBAHRE is a french, regional study, involving 9 centers. Recruitment will take place in all the departments of the centers involved under the supervision of the Infection Control Team.
All patients hospitalized more than 24 hours, on a given day are eligible for the protocol, except the patients unable to answer the questionnaire.
After collecting the non-opposition of the patient, patients will be screened by rectal swab and a questionnaire will be completed.
Each sample will be analyzed to detect eXDR carrying patients.
The carrying patients will be followed during 6 months to estimate the proportion of the population which developped a bacterial infection. This information will be collected by a retrospective telephone survey of carrying patients.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Paris, Frankrike
- HEGP
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Hospitalization of more than 24 hours
- Give his no objection
Exclusion Criteria:
- Hospitalization in psychiatry
- Unwilling to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors
Tidsramme: at inclusion
|
Identification of risk factors for digestive colonisation by highly resistant bacteria Lifestyle questionnaire: environment, diet, medical history and result of the rectal swab
|
at inclusion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of multidrug-resistant bacteria will be determined by the number of patients who have been detected at least one multidrug-resistant bacteria referred to the number of patients sampled
Tidsramme: 1 day
|
Number of patient carrying a Multidrug-resistant bacteria in Ile de France
|
1 day
|
|
Prevalence of co-carrying patients of eXDR and ESBL will be determined by the number of patients who carrying eXDR and ESBL referred to the number of patients sampled
Tidsramme: 1 day
|
Estimate the prevalence of "co-carrying patients of eXDR and ESBL in the Ile de France
|
1 day
|
|
Prevalence will be determined by the number of patients who carrying at least one Multidrug-resistant bacteria referred to the number of patients sampled
Tidsramme: 1 day
|
Establish whether there are significant differences between hospital associated with the recruitment of these institutions.
|
1 day
|
|
Proportion of patients carrying "eXDR" who will develop an infection with the same germ referred to the number of eXDR carriers
Tidsramme: 6 months
|
Estimate the proportion of patients colonized by a "eXDR" who will develop an infection with the same germ.
|
6 months
|
|
Cross-transmission rate of eXDR
Tidsramme: 1 day
|
Number of cross transmissions during the study by comparing the eXDR bacteria genotypes in the same unit
|
1 day
|
|
Description of the association between strains (RAPD, infrared Biotyper, genome sequencing).
Tidsramme: 16 months
|
Identify possible links between strains
|
16 months
|
|
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
Tidsramme: 16 months
|
Characterize the resistance and virulence factors of certain strains.
|
16 months
|
|
Comparison of the frequency of positive presence of eXDR bacteria obtained between culture technic and molecular biology technic
Tidsramme: 16 months
|
Comparison culture vs molecular biology technics.
|
16 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Najiby Kassis-Chikhani, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris
- Hovedetterforsker: Jean-Ralph Zahar, PhD, AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny
- Hovedetterforsker: Véronique Moulin, AP-HP, Hôpital Corentin Celton, et Vaugirard
- Hovedetterforsker: Pierre Frange, PhD, AP-HP, Hôpital Necker enfants malades, Paris
- Hovedetterforsker: Christine Lawrence, PhD, AP-HP, Hôpital Raymond Poincaré, Garches
- Hovedetterforsker: Frédéric Barbut, PhD, AP-HP-Hôpital Saint Antoine, Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CODBAHRE
- APHP180561 (Annen identifikator: AP-HP)
- 2019-A01226-51 (Annen identifikator: IDRCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .