Multi Drug Resistant OrganismsNCT07134270
Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients
An observational study of Multi Drug Resistant Organisms, run by Valeriu Gheorghita at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Drug Resistant Organisms
- What is being tested?
- MDRO Rectal Screening and 30-Day Telephone Follow-Up
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years
- Admitted to participating wards
- Signed informed consent
Who cannot join
- withdrawal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Emergency and Clinical Hospital Dr. Agrippa Ionescu
Bucharest, Bucharest, 011359
Valeriu Gheorghita, Prof. Univ., +40377720000, secretariat.agrippa@dcti.ro
Ana Dobrin, Dr., +40745325335, dr.ana.dobrin@gmail.com
About this study
Official title: Association Between Digestive MDRO Carriage and Infection Risk in Hospitalized Patients: A Single-Center Prospective Analysis
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.
Read the 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
- Conditions
- Multi Drug Resistant Organisms
- Being tested
- MDRO Rectal Screening, 30-Day Telephone Follow-Up
- Keywords
- MDRO, ESBL, CRE, CRPA, CRAB, VRE, hospital-acquired infections, digestive carriage, antimicrobial resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDRO Rectal ScreeningProcedure or 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-UpOther
Structured phone interview conducted 30 days post-discharge, using a standardized questionnaire assessing new infections, rehospitalizations, antibiotic use, and self-rated health status.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: MDRO Rectal Screening; Other: 30-Day Telephone Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of healthcare-associated infections during hospitalization
Rate of infections in MDRO carriers versus non-carriers.
Measured: Up to 30 days after discharge
Secondary outcomes (5)
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).
Measured: Within 48 hours of hospital admission
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.
Measured: From admission to discharge (up to 28 days)
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
Measured: At enrollment
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
Measured: At enrollment
Charlson Comorbidity Index scores among MDRO carriers
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jan 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Drug Resistant OrganismsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valeriu Gheorghita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valeriu Gheorghita, Emergency and Clinical Hospital "Dr. Agrippa Ionescu"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134270
- Sponsor's protocol ID
- 289334/29.04.2025
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to data protection regulations (GDPR - EU 2016/679) and the ethical requirement to ensure confidentiality of participant-level data. Only aggregated, anonymized results may be published.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Digestive MDRO Carriage and Infection Risk in Hospitalized Patients: A Single-Center Prospective Analysis
- ClinicalTrials.gov ID
- NCT07134270
- Acronym / sponsor ID
- 289334/29.04.2025
- Conditions
- Multi Drug Resistant Organisms
- Keywords
- MDRO, ESBL, CRE, CRPA, CRAB, VRE, hospital-acquired infections, digestive carriage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Valeriu GheorghitaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDRO Carriers | – | Procedure: MDRO Rectal Screening, Other: 30-Day Telephone Follow-UpPatients 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. |
| Non-Carriers | – | Procedure: MDRO Rectal Screening, Other: 30-Day Telephone Follow-UpPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years
- Admitted to participating wards
- Signed informed consent
Key exclusion criteria (1 listed)
- withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDRO Rectal ScreeningRepeated 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. | Procedure or surgery | MDRO Carriers, Non-Carriers |
| 30-Day Telephone Follow-UpStructured phone interview conducted 30 days post-discharge, using a standardized questionnaire assessing new infections, rehospitalizations, antibiotic use, and self-rated health status. | Other | MDRO Carriers, Non-Carriers |
Primary outcome
Incidence of healthcare-associated infections during hospitalization
Time frame: Up to 30 days after discharge
Rate of infections in MDRO carriers versus non-carriers.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to data protection regulations (GDPR - EU 2016/679) and the ethical requirement to ensure confidentiality of participant-level data. Only aggregated, anonymized results may be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi Drug Resistant Organisms, run by Valeriu Gheorghita at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeriu Gheorghita, Prof. Univ. (+40377720000, secretariat.agrippa@dcti.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of healthcare-associated infections during hospitalization (time frame: Up to 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.