Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit

Официальное название

Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae (ESBLE) in a Geriatric Unit: an Interventional Prospective Noninferiority Non-randomized Double-blind Controlled Before and After Study

Обзор

This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study. The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.

Подробное описание

Healthcare-associated infections (HAIs) are one of the main causes of morbidity and mortality worldwide. Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have become microorganisms frequently found in HAIs, which reduces the therapeutic possibilities.

Вмешательства

• Другое Discontinuation of contact precautions for ESBLE
  Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE

Первичные конечные точки

• Incidence density of acquired ESBLE [Срок оценки: during 6 month period]

Вторичные конечные точки (5)

• Incidence density of acquired ESBLE by species during 6 month period [Срок оценки: during 6 month period]
• The rate of compliance with hand hygiene in health care providers [Срок оценки: Up to 3 months per health department]
• Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers [Срок оценки: Up to 3 months per health department]
• The rate of compliance with personal protective equipment [Срок оценки: Up to 3 months per health department]
• Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS) [Срок оценки: on the day of discharge of the geriatric unit, on average on the 11th day]

Критерии участия

Критерии включения

• Adult patient (> 65 years old)
• Patient hospitalized in geriatrics during the study period
• Free and informed consent obtained from the patient (or his trusted person or legal representative) within 48 hours of its admission at the geriatric unit
• Patient affiliated to a social security scheme

Non Inclusion Criteria:

• Patient requiring contact precaution for an indication other than ESBLE (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC) on admission
• Patient under legal protection
• Person deprived of liberty

Критерии исключения

• Patient requiring contact precaution for an indication other than ESBL during the patient stay (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC)
• Patient's stay period less than 4 days

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHR Metz-Thionville/Hôpital Bel Air — Metz

Идентификаторы

NCT: NCT05475574 · 2021-05-CHRMT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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