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临床试验/NCT07134270
NCT07134270招募中不适用

Association Between Digestive MDRO Carriage and Infection Risk in Hospitalized Patients: A Single-Center Prospective Analysis

Valeriu Gheorghita2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
2
主要终点
Incidence of healthcare-associated infections during hospitalization

研究概览

简要总结

This study aims to evaluate the impact of digestive carriage of multidrug-resistant organisms (MDRO) on the risk of healthcare-associated infections in hospitalized adult patients. Patients will be screened at admission, weekly, and at discharge, with a 30-day post-discharge follow-up. The findings will support infection prevention and control strategies in Romanian hospitals.

详细描述

This is a prospective, observational cohort study conducted at the Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu" in Bucharest, Romania. The study aims to assess the epidemiology and clinical impact of digestive colonization with multidrug-resistant organisms (MDRO) in hospitalized adult patients. MDROs of interest include extended-spectrum beta-lactamase-producing Enterobacterales (ESBL), carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant non-fermenting Gram-negative bacilli (Pseudomonas aeruginosa, Acinetobacter baumannii), and vancomycin-resistant Enterococcus spp. (VRE).

Eligible participants are ≥18 years old and admitted to one of the following hospital departments: General Surgery, Internal Medicine, Infectious Diseases, Hematology, Oncology, or Intensive Care Unit (ICU). A minimum of 400 patients will be enrolled and followed during hospitalization and up to 30 days post-discharge.

Upon enrollment, patients will undergo rectal swab screening for MDRO carriage at baseline (within 14 days prior to or at admission), on day 7 of hospitalization, weekly thereafter, and at discharge. Data on comorbidities (including Charlson Comorbidity Index), prior hospitalizations or surgeries, recent antibiotic exposure, and potential epidemiologic risk factors (e.g., travel to endemic areas) will be collected.

The primary objective is to assess the cumulative risk of developing healthcare-associated infections (HAIs) during hospitalization in patients with digestive carriage of MDRO compared to those without. Secondary objectives include:

Estimation of the MDRO carriage prevalence at admission;

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to participating wards
  • Signed informed consent

排除标准

  • withdrawal

研究组 & 干预措施

MDRO Carriers

Patients with confirmed digestive (rectal) carriage of multidrug-resistant organisms (MDRO), detected through rectal swab at admission. These include ESBL-producing Enterobacterales, CRE, CRPA, CRAB, and VRE.

干预措施: MDRO Rectal Screening (Procedure)

MDRO Carriers

Patients with confirmed digestive (rectal) carriage of multidrug-resistant organisms (MDRO), detected through rectal swab at admission. These include ESBL-producing Enterobacterales, CRE, CRPA, CRAB, and VRE.

干预措施: 30-Day Telephone Follow-Up (Other)

Non-Carriers

Patients with negative screening for MDRO carriage at admission. These individuals serve as the control cohort for assessing infection risk in the absence of digestive colonization at admission.

干预措施: MDRO Rectal Screening (Procedure)

Non-Carriers

Patients with negative screening for MDRO carriage at admission. These individuals serve as the control cohort for assessing infection risk in the absence of digestive colonization at admission.

干预措施: 30-Day Telephone Follow-Up (Other)

结局指标

主要结局

Incidence of healthcare-associated infections during hospitalization

时间窗: Up to 30 days after discharge

Rate of infections in MDRO carriers versus non-carriers.

次要结局

  • Prevalence of MDRO Digestive Carriage at Admission(Within 48 hours of hospital admission)
  • Rate of Conversion from Negative to Positive MDRO Carriage During Hospitalization(From admission to discharge (up to 28 days))
  • Distribution of demographic and hospitalization-related characteristics among MDRO carriers(At enrollment)
  • Prevalence of recent antibiotic use among MDRO carriers(At enrollment)
  • Charlson Comorbidity Index scores among MDRO carriers(At enrollment)

研究者

发起方
Valeriu Gheorghita
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Valeriu Gheorghita

Prof. Univ. Dr.

Emergency and Clinical Hospital "Dr. Agrippa Ionescu"

研究点 (2)

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