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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Paris、フランス
- HEGP
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Hospitalization of more than 24 hours
- Give his no objection
Exclusion Criteria:
- Hospitalization in psychiatry
- Unwilling to participate
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Risk factors
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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).
時間枠：16 months
|
Identify possible links between strains
|
16 months
|
|
Description of resistance and virulence characteristics between strains (RAPD, infrared Biotyper, genome sequencing).
時間枠：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
時間枠：16 months
|
Comparison culture vs molecular biology technics.
|
16 months
|
協力者と研究者
捜査官
- 主任研究者：Najiby Kassis-Chikhani, PhD、AP-HP, Hôpital Européen Georges Pompidou, Paris
- 主任研究者：Jean-Ralph Zahar, PhD、AP-HP, Hôpitaux Avicenne, Jean Verdier, et René Muret, Bobigny
- 主任研究者：Véronique Moulin、AP-HP, Hôpital Corentin Celton, et Vaugirard
- 主任研究者：Pierre Frange, PhD、AP-HP, Hôpital Necker enfants malades, Paris
- 主任研究者：Christine Lawrence, PhD、AP-HP, Hôpital Raymond Poincaré, Garches
- 主任研究者：Frédéric Barbut, PhD、AP-HP-Hôpital Saint Antoine, Paris
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CODBAHRE
- APHP180561 (その他の識別子：AP-HP)
- 2019-A01226-51 (その他の識別子：IDRCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有時間枠
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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