Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs in Patients With Hematological Diseases in China (CROSS)
Carbapenem-resistant Organisms (CRO) Screening From Rectal Swabs and the Relationship Between Colonization and Infection in Patients With Hematological Diseases in China
Carbapenem-resistant Organisms (CRO) include Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB). Due to the high fatality rate of CRO infection, and its potential for wide spread, it is currently one of the issues that seriously affect the global public health safety. In 2019, CDC of the United States listed CRE and CRAB as the highest level of "antibiotic-resistant bacteria with urgent threat", while CRPA was listed as "antibiotic-resistant bacteria with serious threat".
Previous studies show that in China, patients with hematological disease are at high-risk of CRE colonization and infection, but there still lack the data of colonization rate of CRPA and CRAB in patients with hematological disease. Intestinal flora is not only an important micro-ecological environment for the human body, but also an important place for the habitation of multidrug-resistant bacteria. The colonization of these bacteria can not only lead to the spread of bacteria in hospital, but also may lead to the translocation infection of carriers. Patients with hematological diseases are often in a state of neutropenia after chemotherapy. At the same time, chemotherapy drugs and various factors can cause intestinal mucosa damage, which is prone to induce intestinal microflora translocation, causing serious infections such as sepsis, and posing a serious threat to the prognosis of patients. Early detection of CRO carriers is not only beneficial to the control of nosocomial infection, but also beneficial to early precise anti-infection treatments, reducing the probability of infection and improving the prognosis of infected patients.
Our study is designed to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases, and the risk factors of intestinal CRO colonization in patients with hematological diseases and its correlation with subsequent infections. 5000 patients diagnosed with hematological diseases will be enrolled, and rectal swabs or feces will be collected to detect the CRE intestinal colonization. Subsequently, the last 6 months clinical data of CRO-colonized patients and matched non CRO-colonized patients (1:1) will be collected. Then, the randomly selected 200 CRO-colonized patients and matched 200 non CRO-colonized patients (1:1) are followed up for 12 months, a total of 400 patients will be enrolled. Every month, rectal swabs and relevant clinical data will be collected.
調査の概要
状態
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Yingzhi Fang, MD
- 電話番号:+86 571 86006811
- メール:fyz4817@126.com
研究場所
-
-
Zhejiang
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Hangzhou、Zhejiang、中国、310016
- 募集
- Sir Run Run Shaw Hospital
-
コンタクト:
- Ying-zhi Fang
- 電話番号:+86 571 86006987
-
主任研究者:
- Yun-song Yu, M.D.
-
-
参加基準
適格基準
就学可能な年齢
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:
- On a certain day in each chosed hospital, all the inpatients diagnosed with hematological malignancies diseases will be enrolled
Exclusion Criteria:
- Patients or their legal representatives refused to enter the study
- Patients died because of hematological malignancies diseases.
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
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
|---|
|
patients with hematological diseases
to clarify the intestinal carriage rate of carbapenem-resistant Organisms (CRO) in patients with hematological diseases
|
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 |
|---|---|---|
|
CRO intestinal colonization incidence
時間枠:1 year since enrollment
|
Positive culture any of these three organsisms: Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Pseudomonas aeruginosa (CRPA) and Carbapenem-resistant Acinetobacter baumannii (CRAB)
|
1 year since enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bloodstream infection incidence
時間枠:1 year after enrollment
|
Blood postive culture of the same organisms found in the rectal swabs
|
1 year after enrollment
|
協力者と研究者
捜査官
- 主任研究者:Yunsong YU, MD、Zhejiang University school of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- SRRSH-CROSS
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?
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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