An observational study in Multi-resistant Gram-negative Bacteria Cause Infection, sponsored by Fundacion SEIMC-GESIDA. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Fundacion SEIMC-GESIDA · Observational
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.
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.
656 studies on the registry are indexed under Virus Diseases; 85 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 442 across 167 observational studies indexed under Virus Diseases.
Browse Virus Diseases studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All the patients entering in ICU
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All the patients entering the ICU colonized by a microorganism
Drug: Standard of care therapy
All the patients entering the ICU not colonized by a microorganism
Drug: Standard of care therapy
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.
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.
Time frame: From ICU admission until hospital discharge or death, assessed up to hospital discharge.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for May 2027, 14 months after the start.
Of 73 non-industry observational studies under Virus Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 108. This study's planned 14 months is below that.
Counting every sponsor, half of 80 studies reached it within 24 months; a quarter within 8 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
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Fundacion SEIMC-GESIDA