Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MDRO Rectal Screening, 30-Day Telephone Follow-Up.
- Who it may be relevant to
- Registry conditions: Multi Drug Resistant Organisms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Digestive MDRO Carriage and Infection Risk in Hospitalized Patients: A Single-Center Prospective Analysis
Overview
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.
Detailed 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
Interventions
- Procedure MDRO Rectal Screening
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. - Other 30-Day Telephone Follow-Up
Structured phone interview conducted 30 days post-discharge, using a standardized questionnaire assessing new infections, rehospitalizations, antibiotic use, and self-rated health status.
Primary outcome measures
- Incidence of healthcare-associated infections during hospitalization [Time frame: Up to 30 days after discharge]
Secondary outcome measures (5)
- Prevalence of MDRO Digestive Carriage at Admission [Time frame: Within 48 hours of hospital admission]
- Rate of Conversion from Negative to Positive MDRO Carriage During Hospitalization [Time frame: From admission to discharge (up to 28 days)]
- Distribution of demographic and hospitalization-related characteristics among MDRO carriers [Time frame: At enrollment]
- Prevalence of recent antibiotic use among MDRO carriers [Time frame: At enrollment]
- Charlson Comorbidity Index scores among MDRO carriers [Time frame: At enrollment]
Eligibility criteria
Inclusion criteria
- 18 years
Admitted to participating wards
Signed informed consent
Exclusion criteria
- withdrawal
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Romania · 1 center
- Emergency and Clinical Hospital Dr. Agrippa Ionescu — Bucharest
Identifiers
NCT: NCT07134270 · 289334/29.04.2025