Intervention in the CPE Surveillance Algorithm and Isolation Re-evaluation With the Addition of PCR vs. Culture-based Protocol: Real-life Time Differences
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Time from surveillance swab request to isolation implementation or discontinuation (hours)
研究概览
简要总结
Purpose:
Carbapenemase-producing Enterobacterales (CPE) are a growing cause of healthcare-associated infections, linked to high morbidity, mortality, and cost. Current screening methods rely mainly on culture, which can take up to 48 hours and delay infection control actions.
This study aims to evaluate the real-life impact of implementing a rapid PCR-based algorithm for CPE detection compared with the standard culture-based protocol, focusing on time differences in isolation and de-isolation decisions in hospitalized patients.
Design:
A quasi-experimental, before-and-after, retrospective study conducted at Hospital Italiano de Buenos Aires (HIBA).
Primary Outcome:
Time (in hours) between rectal swab request and change in isolation status (application or removal of isolation label) before and after PCR implementation.
Population:
Adult patients (≥18 years) admitted between October 2023-April 2024 (pre-intervention) and October 2024-April 2025 (post-intervention), who had contact isolation initiated or discontinued based on CPE surveillance results.
Rationale:
The introduction of rapid molecular testing could reduce operational delays and unnecessary isolation days, optimizing resource use in a setting with high CPE endemicity.
详细描述
Background:
Carbapenemase-producing Enterobacterales (CPE) are critical-priority pathogens associated with increased morbidity, mortality, and healthcare costs. Screening and isolation are recommended infection control measures, yet delays inherent to culture-based methods can hinder timely decision-making and overuse limited isolation rooms.
Objective:
To compare the time to initiation and discontinuation of contact isolation-from swab request to result availability and isolation status update-before and after implementing a rapid PCR-based diagnostic protocol for CPE identification.
Design and Setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged ≥18 years
- •Patients screened for carbapenemase-producing Enterobacterales (CPE) carriage by perianal swab within the first 5 days of hospital admission
- •Patients newly identified as CPE-colonized, leading to initiation of contact isolation
- •Patients found to be decolonized, leading to discontinuation of contact isolation
- •Patients with indication for active surveillance at hospital admission:
- •Transfer from another healthcare facility
- •Hospitalization in another healthcare center within the previous month
- •Patients undergoing active surveillance during hospitalization:
- •First surveillance swab in high-risk neutropenic patients (HAR flag)
- •First surveillance swab in immunosuppressed units, such as hematopoietic stem-cell transplant wards
- •Patients evaluated for discontinuation of contact precautions who meet all of the following:
- •Prior CPE-positive surveillance sample
- •At least 3 months since the last positive result and last hospitalization
- •No systemic antibiotic exposure during that period
排除标准
- •Lost samples
- •Insufficient samples
- •Invalid laboratory test results requiring repeat sampling
研究组 & 干预措施
Pre-intervention period
The baseline phase preceding the implementation of the rapid PCR-based algorithm. During this period, the institutional workflow for carbapenemase-producing Enterobacterales (CPE) surveillance and isolation reevaluation relied exclusively on culture-based methods. Patients evaluated for CPE carriage or decolonization were tested using CHROMagar™ KPC and phenotypic confirmation methods (including MALDI-TOF and NG-Test CARBA 5 when indicated). Discontinuation of isolation required either three negative cultures or two negative cultures plus one PCR performed at least three months after the last positive result. No modification of staffing, alert systems, or isolation criteria occurred during this period.
Post-intervention period
The implementation phase beginning November 6, 2024, when the rapid PCR-based diagnostic algorithm for carbapenemase-producing Enterobacterales (CPE) was incorporated into the existing infection control workflow. Real-time PCR was performed using the BD MAX™ System to detect bla_KPC, bla_NDM, bla_VIM/IMP, and bla_OXA-48-like genes directly from rectal swabs. The infection control team coordinated sample requests, result communication, and isolation/de-isolation actions. The new algorithm prioritized PCR testing for surveillance and discontinuation of isolation in patients not receiving antibiotics, replacing culture-based testing in those scenarios.
干预措施: Rapid PCR-based algorithm for CPE detection (Diagnostic Test)
结局指标
主要结局
Time from surveillance swab request to isolation implementation or discontinuation (hours)
时间窗: From the date and time of electronic request for perianal swab collection until the date and time of isolation status update in the EHR, assessed up to 168 hours (7 days).
Primary Outcome Measure 1\. Operational time from surveillance swab request to isolation status change (hours) Description: Time elapsed between the electronic request for perianal surveillance swab (clinical suspicion) and the implementation or discontinuation of the carbapenemase-producing Enterobacterales (EPC) isolation logo in the electronic health record (EHR). Unit of Measure: Hours
次要结局
- Sample collection delay (hours)(From the date and time of electronic request for perianal swab collection until laboratory check-in of the sample, assessed up to 72 hours.)
- Laboratory processing delay (hours)(From the date and time of laboratory check-in until the date and time of final laboratory result, assessed up to 96 hours.)
- Action delay after laboratory result (hours)(From the date and time of final laboratory result until the date and time of isolation status update in the EHR, assessed up to 72 hours.)
研究者
EMILIO FELIPE HUAIER ARRIAZU
Emilio Felipe Huaier Arriazu, MD. Principal Investigator, Infection Control Committee
Hospital Italiano de Buenos Aires