GRAM NEGATIVES STUDY

NCT07749508 | Recruiting FDA Drug

• 1 other identifier: GEIPC 01-24
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Multi-resistant Gram-negative Bacteria Cause Infection

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From ICU admission until hospital discharge or death, assessed up to hospital discharge.

Study Arms (2)

Arm of colonized patients

All the patients entering the ICU colonized by a microorganism

Drug: Standard of care therapy

Control Arm

All the patients entering the ICU not colonized by a microorganism

Drug: Standard of care therapy

Interventions

Standard of care therapy DRUG

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.

Arm of colonized patients; Control Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients entering in ICU

You may qualify if:

• Patients aged ≥18 years
• Have given informed consent.

You may not qualify if:

• Patients who do not agree to participate in the study
• Admission to the ICU \< 24 hours

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Montserrat Aguirregabiria, Principal Investigator

CONTACT

034687428599; montseara17@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 6, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)