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Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients

ConditionMulti Drug Resistant Organisms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorValeriu Gheorghita

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years

Disqualifiers

withdrawal

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MDRO Rectal Screening

    Procedure/Surgery

    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.

  • 30-Day Telephone Follow-Up

    Other intervention

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: MDRO Carriers2 interventions
Group B: Non-Carriers2 interventions

Trial outcomes

Primary outcomes

1

Incidence of healthcare-associated infections during hospitalization

Rate of infections in MDRO carriers versus non-carriers.

Time frame
Up to 30 days after discharge

Secondary outcomes

1

Prevalence of MDRO Digestive Carriage at Admission

Proportion of participants testing positive for digestive colonization with multidrug-resistant organisms (MDRO) via rectal swab at baseline (admission or within 14 days prior). MDROs include ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant Pseudomonas aeruginosa (CRPA), Acinetobacter baumannii (CRAB), and vancomycin-resistant Enterococcus (VRE).

Time frame
Within 48 hours of hospital admission
2

Rate of Conversion from Negative to Positive MDRO Carriage During Hospitalization

Proportion of participants who initially tested negative for MDRO digestive carriage at admission but later became positive on subsequent screening during hospitalization. Conversion will be assessed through weekly rectal swabs and swab at discharge.

Time frame
From admission to discharge (up to 28 days)
3

Distribution of demographic and hospitalization-related characteristics among MDRO carriers

Age, sex, and number of hospitalizations in the last 6 months among participants colonized with MDRO at enrollment

Time frame
At enrollment
4

Prevalence of recent antibiotic use among MDRO carriers

Proportion of MDRO carriers who received antibiotic treatment (at least 72 h) in the last 6 months, stratified by antibiotic class and duration

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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Valeriu Gheorghita

Lead sponsor

Emergency and Clinical Hospital "Dr. Agrippa Ionescu"

Sponsor institution

Source ClinicalTrials.gov
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