Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)
Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).
調査の概要
詳細な説明
Methicillin-resistant Staphylococcus aureus (MRSA) strains have become endemic pathogens in acute and chronic healthcare facilities in Belgium. MRSA infection is causing increased public concern as it carries a significant risk of morbidity, mortality and has been linked to substantial excess healthcare costs.
Efficient control of MRSA transmission within healthcare facilities critically depends on screening for and isolation of MRSA carriers among admitted patients. Active surveillance cultures for MRSA are now part of clinical practice recommendations both in Europe and the USA. Indeed, studies have indicated that up to 70 % of the patient reservoir for MRSA among hospitalized patients can only be detected by active sampling of muco-cutaneous colonization sites. There is an urgent public health need for early and reliable detection of carriers of MRSA among patients admitted to healthcare facilities, to inform patient isolation and decontamination procedures, and thereby more effectively control cross-infection
The general objectives of this intervention study to be conducted in two large Belgian hospitals are to measure the impact of rapid (< 3 h) PCR detection of MRSA carriage upon patient admission on shortening the delay to implement contact isolation precautions for carriers and reducing nosocomial MRSA transmission to patients admitted in the same wards.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Brugge、ベルギー、B-8000
- Algemeen Ziekenhuis Sint-Jan AV
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Brussels、ベルギー、B-1070
- ULB Hôpital Erasme
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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
説明
Inclusion Criteria:
All patients admitted for more than 48h to a ward in which evaluation in the previous baseline period met the following:
- > 80 % compliance with admission and discharge conventional culture screening, for the pooled admissions to all study wards;
- > 80 % compliance with additional MRSA contact isolation procedures, based on a sample of 50 patient care contact observations per hospital in all study wards;
- pooled incidence of nosocomial MRSA acquisition ≥ 1.5 new cases /100 at risk admissions in the study wards.
Exclusion Criteria:
- Patients staying 48h or less in the study wards
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Rapid PCR screen
Rapid PCR screen test for detection of MRSA carriers upon hospital admission
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In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission.
To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.
他の名前：
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アクティブコンパレータ：Conventional culture
Conventional culture screen for detection of MRSA carriers upon hospital admission
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In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission.
To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.
他の名前：
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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 |
時間枠 |
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To determine if a ≥ 50 % reduction of incidence of nosocomial MRSA acquisition can be observed after replacing culture by PCR for universal MRSA screening of patients upon admission to high incidence units in two acute care hospitals
時間枠：5-10 months
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5-10 months
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二次結果の測定
結果測定 |
時間枠 |
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Median time required for detection of MRSA carriage after admission
時間枠：5-10 months
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5-10 months
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Median time required for starting isolation of MRSA carriers
時間枠：5-10 months
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5-10 months
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Number of patient-days of MRSA carrier stay in non-isolated conditions
時間枠：5-10 months
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5-10 months
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MRSA nosocomial infection rate
時間枠：5-10 months
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5-10 months
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MRSA cross-transmission rate
時間枠：5-10 months
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5-10 months
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Sensitivity and specificity of PCR vs conventional MRSA screening by culture
時間枠：10 months
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10 months
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協力者と研究者
捜査官
- 主任研究者：Marc J Struelens, MD, PhD、Erasme University Hospital
出版物と役立つリンク
一般刊行物
- Struelens MJ, Denis O. Rapid molecular detection of methicillin-resistant Staphylococcus aureus: a cost-effective tool for infection control in critical care? Crit Care. 2006;10(2):128. doi: 10.1186/cc4855.
- Roisin S, Laurent C, Denis O, Dramaix M, Nonhoff C, Hallin M, Byl B, Struelens MJ. Impact of rapid molecular screening at hospital admission on nosocomial transmission of methicillin-resistant Staphylococcus aureus: cluster randomised trial. PLoS One. 2014 May 16;9(5):e96310. doi: 10.1371/journal.pone.0096310. eCollection 2014.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- Erasme-ULB-P2008/201
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