Multi-resistant Gram-negative Bacteria Cause InfectionMR-GEIPCNCT07749508
GRAM NEGATIVES STUDY
An observational study of Multi-resistant Gram-negative Bacteria Cause Infection, run by Fundacion SEIMC-GESIDA at 1 site in Spain.
Trial summary
This is a prospective, observational, multicenter study whose main objective is to develop a predictive model of mortality in critically ill patients colonized by multidrug-resistant Gram-negative bacteria (MDR-GNB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multi-resistant Gram-negative Bacteria Cause Infection
- How many people
- 1,500 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2026to 31 May 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients entering in ICU
Who may be able to join
- Patients aged ≥18 years
- Have given informed consent.
Who cannot join
- Patients who do not agree to participate in the study
- Admission to the ICU < 24 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Montserrat Aguirregabiria, Principal Investigator, 034687428599, montseara17@gmail.com
About this study
Official title: Design of a Predictive Model of Mortality in Critically Ill Patients Colonized by Multiresistant Gram-negative Bacteria. MR-GEIPC STUDY
This is a prospective, observational, multicenter study whose main objective is to develop a predictive model of mortality in critically ill patients colonized by multidrug-resistant Gram-negative bacteria (MDR-GNB).
Secondary objectives include: determining the characteristics of patients colonized by MRGB who require admission or acquire colonization during their stay in an intensive care unit (ICU); studying the infectious complications they develop, their etiology, clinical impact, and prognosis.
Read the detailed description
This is a prospective, observational, multicenter study whose main objective is to develop a predictive model of mortality in critically ill patients colonized by multidrug-resistant Gram-negative bacteria (MDR-GNB).
Secondary objectives include: determining the characteristics of patients colonized by MRGB who require admission or acquire colonization during their stay in an intensive care unit (ICU); studying the infectious complications they develop, their etiology, clinical impact, and prognosis.
During the first month of data collection, all patients admitted to the ICU will be included regardless of their carrier status. Non-colonized patients will act as a "control group" and will allow us to evaluate the differences between the 'colonized' and "non-colonized" populations in the future.
Patients with positive samples for extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, carbapenemases, Pseudomonas aeruginosa, and multidrug-resistant Acinetobacter baumannii will be included in the study.
Data will be collected on the infectious complications they develop (a maximum of two per patient): bacteremia, ventilator-associated pneumonia, urinary catheter-associated infection, sepsis with an abdominal focus, and skin and soft tissue infections. (Priority will be given to recording the first two due to their greater clinical impact on critically ill patients).
The severity, need for artificial support treatment, and etiology of each infection will be analyzed. Data from the antibiogram will be collected, with special interest in sensitivities to carbapenems and new antibiotics available (ceftazidime-avibactam, ceftolozane-tazobactam, meropenem-vaborbactam, imipenem-relebactam, and cefiderocol). The adequacy and timeliness of the prescribed antimicrobial treatment will be analyzed. Clinical cure of the episode, recurrence, and the emergence of resistance to new antibiotics will be evaluated.
From the second month onwards, only patients colonized by multidrug-resistant Gram-negative bacteria upon admission, or those who acquire it during their stay in the ICU, will be included. A colonized patient will be considered to be one with at least one positive microbiological surveillance culture according to the RZ protocol, regardless of location. Colonization will be considered if any sample from the epidemiological study is positive upon admission to the ICU or if they acquire colonization during their stay. Colonization will be considered based on the results of the first study performed upon admission to the ICU or during the ICU stay, in cases where it is acquired during the stay in the unit. The main infectious complications that these patients develop, their etiology, and clinical impact will be recorded.
- Being tested
- Standard of care therapy
- Keywords
- Intensive Care Unit, Critical Patients, Multidrug Resistant Bacteria, Fungical infections, Viral infections, Gram-negative colonization, Focus of infection, Sequential Organ Failure Assessment, Gram-Negatives, Increment score, Charlson index, Glasgow coma scale
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care therapyDrug
This is an observational study. Patients receive standard of care therapy as part of routine clinical practice according to the physician's discretion. No experimental intervention is assigned by the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm of colonized patients | All the patients entering the ICU colonized by a microorganism Receives: Drug: Standard of care therapy | |
| Control Arm | All the patients entering the ICU not colonized by a microorganism Receives: Drug: Standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital all-cause mortality
Development and validation of a predictive model for in-hospital mortality in patients colonized by multidrug-resistant Gram-negative bacteria admitted to intensive care units.
Measured: From ICU admission until hospital discharge or death, assessed up to hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start2 Mar 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-resistant Gram-negative Bacteria Cause InfectionStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749508
- Sponsor's protocol ID
- GEIPC 01-24
- Acronym
- MR-GEIPC
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Predictive Model of Mortality in Critically Ill Patients Colonized by Multiresistant Gram-negative Bacteria. MR-GEIPC STUDY
- ClinicalTrials.gov ID
- NCT07749508
- Acronym / sponsor ID
- MR-GEIPC / GEIPC 01-24
- Keywords
- Intensive Care Unit, Critical Patients, Multidrug Resistant Bacteria, Fungical infections, Viral infections, Gram-negative colonization, Focus of infection, Sequential Organ Failure Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Aug 2026 (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 is a prospective, observational, multicenter study whose main objective is to develop a predictive model of mortality in critically ill patients colonized by multidrug-resistant Gram-negative bacteria (MDR-GNB).
Secondary objectives include: determining the characteristics of patients colonized by MRGB who require admission or acquire colonization during their stay in an intensive care unit (ICU); studying the infectious complications they develop, their etiology, clinical impact, and prognosis.
Detailed description
This is a prospective, observational, multicenter study whose main objective is to develop a predictive model of mortality in critically ill patients colonized by multidrug-resistant Gram-negative bacteria (MDR-GNB).
Secondary objectives include: determining the characteristics of patients colonized by MRGB who require admission or acquire colonization during their stay in an intensive care unit (ICU); studying the infectious complications they develop, their etiology, clinical impact, and prognosis.
During the first month of data collection, all patients admitted to the ICU will be included regardless of their carrier status. Non-colonized patients will act as a "control group" and will allow us to evaluate the differences between the 'colonized' and "non-colonized" populations in the future.
Patients with positive samples for extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, carbapenemases, Pseudomonas aeruginosa, and multidrug-resistant Acinetobacter baumannii will be included in the study.
Data will be collected on the infectious complications they develop (a maximum of two per patient): bacteremia, ventilator-associated pneumonia, urinary catheter-associated infection, sepsis with an abdominal focus, and skin and soft tissue infections. (Priority will be given to recording the first two due to their greater clinical impact on critically ill patients).
The severity, need for artificial support treatment, and etiology of each infection will be analyzed. Data from the antibiogram will be collected, with special interest in sensitivities to carbapenems and new antibiotics available (ceftazidime-avibactam, ceftolozane-tazobactam, meropenem-vaborbactam, imipenem-relebactam, and cefiderocol). The adequacy and timeliness of the prescribed antimicrobial treatment will be analyzed. Clinical cure of the episode, recurrence, and the emergence of resistance to new antibiotics will be evaluated.
From the second month onwards, only patients colonized by multidrug-resistant Gram-negative bacteria upon admission, or those who acquire it during their stay in the ICU, will be included. A colonized patient will be considered to be one with at least one positive microbiological surveillance culture according to the RZ protocol, regardless of location. Colonization will be considered if any sample from the epidemiological study is positive upon admission to the ICU or if they acquire colonization during their stay. Colonization will be considered based on the results of the first study performed upon admission to the ICU or during the ICU stay, in cases where it is acquired during the stay in the unit. The main infectious complications that these patients develop, their etiology, and clinical impact will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm of colonized patients | – | Drug: Standard of care therapyAll the patients entering the ICU colonized by a microorganism |
| Control Arm | – | Drug: Standard of care therapyAll the patients entering the ICU not colonized by a microorganism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients entering in ICU
Key inclusion criteria (2 listed)
- Patients aged ≥18 years
- Have given informed consent.
Key exclusion criteria (2 listed)
- Patients who do not agree to participate in the study
- Admission to the ICU < 24 hours
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 |
|---|---|---|
| Standard of care therapyThis is an observational study. Patients receive standard of care therapy as part of routine clinical practice according to the physician's discretion. No experimental intervention is assigned by the protocol. | Drug | Arm of colonized patients, Control Arm |
Primary outcome
In-hospital all-cause mortality
Time frame: From ICU admission until hospital discharge or death, assessed up to hospital discharge.
Development and validation of a predictive model for in-hospital mortality in patients colonized by multidrug-resistant Gram-negative bacteria admitted to intensive care units.
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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-resistant Gram-negative Bacteria Cause Infection, run by Fundacion SEIMC-GESIDA at 1 site in Spain.
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 2 inclusion and 2 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 6 Aug 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 Spain. 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 Montserrat Aguirregabiria, Principal Investigator (034687428599, montseara17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital all-cause mortality (time frame: From ICU admission until hospital discharge or death, assessed up to hospital 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 6 Aug 2026.