Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients

Valeriu Gheorghita

Status: Not yet enrolling

Conditions: Multi Drug Resistant Organisms

Treatments: Other: 30-Day Telephone Follow-Up; Procedure: MDRO Rectal Screening

Study type: Observational

Funder types: Other

Identifiers

NCT07134270

289334/29.04.2025

Details and patient eligibility

About

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.

Full description

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;

Assessment of conversion from negative to positive carriage during hospitalization;

Characterization of clinical and epidemiologic profiles associated with MDRO carriage;

Identification of etiologic patterns and resistance mechanisms.

A structured follow-up by telephone will be conducted 30 days after discharge, including a standardized questionnaire assessing new infections, rehospitalizations, antibiotic use, and perceived health status.

Collected microbiological data may be correlated with molecular characterization (e.g., resistance genes, phylogenetic analysis) through collaboration with the "Cantacuzino" National Institute for Research and Development in Military Medicine.

All procedures comply with the Declaration of Helsinki and GDPR regulations. Participation is voluntary, and patients may withdraw at any time without consequences for their medical care

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years

Admitted to participating wards

Signed informed consent

Exclusion criteria

• withdrawal

Trial design

400 participants in 2 patient groups

MDRO Carriers

Description:

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.

Treatment:

Procedure: MDRO Rectal Screening

Other: 30-Day Telephone Follow-Up

Non-Carriers

Description:

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.

Treatment:

Procedure: MDRO Rectal Screening

Other: 30-Day Telephone Follow-Up