Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients

NCT07134270 | Recruiting DMC

• 1 other identifier: 289334/29.04.2025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multi Drug Resistant Organisms

Keywords

MDRO; ESBL; CRE; CRPA; CRAB; VRE; hospital-acquired infections; digestive carriage; antimicrobial resistance

Outcome Measures

Primary Outcomes (1)

• Incidence of healthcare-associated infections during hospitalization

  Rate of infections in MDRO carriers versus non-carriers.

  Up to 30 days after discharge

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

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

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.

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

Interventions

MDRO Rectal Screening PROCEDURE

Repeated rectal swab collection for screening digestive colonization with multidrug-resistant organisms (MDRO), performed at admission (or within 14 days prior), on day 7, weekly during hospitalization, and at discharge.

MDRO Carriers; Non-Carriers

30-Day Telephone Follow-Up OTHER

Structured phone interview conducted 30 days post-discharge, using a standardized questionnaire assessing new infections, rehospitalizations, antibiotic use, and self-rated health status.

MDRO Carriers; Non-Carriers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) admitted to medical and surgical departments of the Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu" in Bucharest, Romania, including Internal Medicine, Infectious Diseases, Hematology, Oncology, General Surgery, and Intensive Care Unit. Participants are enrolled consecutively and undergo screening for digestive MDRO carriage during hospitalization.

You may qualify if:

• years
• Admitted to participating wards
• Signed informed consent

You may not qualify if:

• withdrawal

Sponsors & Collaborators

• Valeriu Gheorghita: lead

Study Sites (1)

Emergency and Clinical Hospital Dr. Agrippa Ionescu

Bucharest, Bucharest, 011359, Romania

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

rectal swabs

Central Study Contacts

Valeriu Gheorghita, Prof. Univ.

CONTACT

+40377720000; secretariat.agrippa@dcti.ro

Ana Dobrin, Dr.

CONTACT

+40745325335; dr.ana.dobrin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Univ. Dr.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)