- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04085380
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Paris, Frankrike
- HEGP
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Hospitalization of more than 24 hours
- Give his no objection
Exclusion Criteria:
- Hospitalization in psychiatry
- Unwilling to participate
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Risk factors
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
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Estimate the proportion of patients colonized by a "eXDR" who will develop an infection with the same germ.
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6 months
|
|
Cross-transmission rate of eXDR
Tidsram: 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).
Tidsram: 16 months
|
Identify possible links between strains
|
16 months
|
|
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
Tidsram: 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
Tidsram: 16 months
|
Comparison culture vs molecular biology technics.
|
16 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Najiby Kassis-Chikhani, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris
- Huvudutredare: Jean-Ralph Zahar, PhD, AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny
- Huvudutredare: Véronique Moulin, AP-HP, Hôpital Corentin Celton, et Vaugirard
- Huvudutredare: Pierre Frange, PhD, AP-HP, Hôpital Necker enfants malades, Paris
- Huvudutredare: Christine Lawrence, PhD, AP-HP, Hôpital Raymond Poincaré, Garches
- Huvudutredare: Frédéric Barbut, PhD, AP-HP-Hôpital Saint Antoine, Paris
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CODBAHRE
- APHP180561 (Annan identifierare: AP-HP)
- 2019-A01226-51 (Annan identifierare: IDRCB)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
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