GRAM NEGATIVES STUDY
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFundacion SEIMC-GESIDA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years
Have given informed consent.
Disqualifiers
Patients who do not agree to participate in the study
Admission to the ICU < 24 hours
Trial population
All the patients entering in ICU
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard of care therapy
DrugThis 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.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Arm of colonized patients1 intervention
Group B: Control Arm1 intervention
Trial outcomes
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.
Time frame
From ICU admission until hospital discharge or death, assessed up to hospital discharge.Sponsors and contacts
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Source ClinicalTrials.gov