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NCT Number: NCT07134270

Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency and Clinical Hospital Dr. Agrippa Ionescu

Bucharest, 011359, Romania

Location status: Recruiting

Location contact

Adrian Tulin, Associated Professor

SUB_INVESTIGATOR

Alin Baciu, Dr

SUB_INVESTIGATOR

Amalia Loredana Călinoiu, Dr

SUB_INVESTIGATOR

Ana Dobrin, Dr

SUB_INVESTIGATOR

Ana Dobrin, Dr.

CONTACT

[email protected]

+40745325335

Ana Dobrotă, Dr

SUB_INVESTIGATOR

Andrei Alexandru Muntean, Assistant Professor

SUB_INVESTIGATOR

Cornelia Nițipir, Prof. Univ.

SUB_INVESTIGATOR

Indira Rădoi, Dr

SUB_INVESTIGATOR

Irina Florentina Talpoși, Dr

SUB_INVESTIGATOR

Maria Adelina Radu, Assistant Lecturer

SUB_INVESTIGATOR

Maria Cristina Orlov-Slavu, Assistant Professor

SUB_INVESTIGATOR

Maria Cristina Văcăroiu, Dr

SUB_INVESTIGATOR

Robert Ciupan, Dr

SUB_INVESTIGATOR

Silvia Chiran, Dr

SUB_INVESTIGATOR

Simona Crintea, Dr

SUB_INVESTIGATOR

Tiberiu Sebastian Holban, Dr

SUB_INVESTIGATOR

Valeriu Gheorghita, Prof. Univ.

CONTACT

[email protected]

+40377720000

Violeta Melinte, Assistant Professor

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years

Admitted to participating wards

Signed informed consent

Exclusion criteria

  • withdrawal

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of healthcare-associated infections during hospitalization

    Time frame: Up to 30 days after discharge

    Rate of infections in MDRO carriers versus non-carriers.

Secondary outcomes

  1. Prevalence of MDRO Digestive Carriage at Admission

    Time frame: Within 48 hours of hospital 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).

  2. Rate of Conversion from Negative to Positive MDRO Carriage During Hospitalization

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

    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.

  3. Distribution of demographic and hospitalization-related characteristics among MDRO carriers

    Time frame: At enrollment

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

  4. Prevalence of recent antibiotic use among MDRO carriers

    Time frame: At enrollment

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

  5. Charlson Comorbidity Index scores among MDRO carriers

    Time frame: At enrollment

    The Charlson Comorbidity Index (CCI) will be used to assess the burden of comorbidities at enrollment among participants with digestive MDRO carriage. The CCI score is calculated based on the presence of predefined conditions (e.g., diabetes, cancer, chronic heart failure), each assigned a weight, resulting in a total score ranging from 0 to 33.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Dobrin, Dr.

CONTACT

[email protected]

+40745325335

Valeriu Gheorghita, Prof. Univ.

CONTACT

[email protected]

+40377720000

Sponsors and collaborators

Lead sponsor

Valeriu Gheorghita

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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