Multi Drug Resistant Organisms
Conditions
Keywords
MDRO, ESBL, CRE, CRPA, CRAB, VRE, hospital-acquired infections, digestive carriage, antimicrobial resistance
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.
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
PROCEDUREMDRO 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.
OTHER30-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.
Sponsors
Valeriu Gheorghita
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years Admitted to participating wards Signed informed consent
Exclusion criteria
* withdrawal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of healthcare-associated infections during hospitalization | Up to 30 days after discharge | Rate of infections in MDRO carriers versus non-carriers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of MDRO Digestive Carriage at Admission | 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). |
| Rate of Conversion from Negative to Positive MDRO Carriage During Hospitalization | 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. |
| Distribution of demographic and hospitalization-related characteristics among MDRO carriers | At enrollment | Age, sex, and number of hospitalizations in the last 6 months among participants colonized with MDRO at enrollment |
| Prevalence of recent antibiotic use among MDRO carriers | 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 |
| Charlson Comorbidity Index scores among MDRO carriers | 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. |
Countries
Romania
Contacts
CONTACTValeriu Gheorghita, Prof. Univ.
CONTACTAna Dobrin, Dr.
Outcome results
None listed