Risk Factors for Multidrug Resistant Bacteria at ICU Admission

Study Overview
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Brief Summary
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The objective of this single-center prospective observational study is to evaluate possible independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by analyzing comorbidities, epidemiological data, and laboratory/microbiological information of the subjects.

Detailed Description
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Background: Infection is one of the main reason for a patient to be admitted to an intensive care unit (ICU) and it's fundamental to use the right antibiotic as soon as possible, possibly needing broad-spectrum antibiotics. However, the main problem is that widening the spectrum of drugs will generate pressure on the hospital microbiota, leading to the development of multi-drug resistant bacteria Purpose: A large number of ICU-admitted patients have infection/sepsis as their major problem, requiring treatment with antibiotics. With knowledge of the presumed risk factors for antibiotic resistance, the assistant physician could use broad-spectrum drugs with greater certainty. Objectives: Our objective will be to evaluate risk factors for infection caused by multi-drug resistant germs upon ICU admission and assess the severity of the disease in comparison to patients infected with susceptible bacteria. Ultimately, we aim to develop and validate a clinical tool to assist physicians in selecting the appropriate antibiotic for their patients Methods: An observational prospective study with a control group will be conducted, including all patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result. Patients with isolation of only susceptible bacteria will be allocated to the control group, while patients with MDR bacteria will be assigned to the study group, referred to as the MDR group. The data to be collected will include sex, age, previous use of antibiotics in the last three months, previous hospital admissions, previous isolation of MDR germs, sensitivity profile of the isolated germs, severity of disease (measured by SAPS 3), presence of sepsis diagnosis at admission, length of stay in the ICU, and 28-day mortality

Official Title
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Risk Factors for Multidrug Resistant Bacteria at ICU Admission

Conditions
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Multi Drug Resistant Bacteria

Intervention / Treatment
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* Diagnostic Test: Identification o Multi Drug Resistant Bacteria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and a microbiological positive result for bacteria Exclusion Criteria: Patients with results considered as contamination according to the institutional protocol. Surgical wound and bloodstream infections. Microbiological isolation of only fungi. Vigilance cultures, such as anal, rectal, nasal, and axillary swabs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multi drug resistant group<br>All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug resistant bacteria isolation : | Diagnostic Test: Identification o Multi Drug Resistant Bacteria<br>* Identification o Multi Drug Resistant Bacteria<br>|
| Multi sensible bacteria group<br>All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug sensible bacteria isolation : | Diagnostic Test: Identification o Multi Drug Resistant Bacteria<br>* Identification o Multi Drug Resistant Bacteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine risk factors for multi-drug resistant germs in ICU admission. | Analysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality between control and case group | Compare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria. | 28 days | 
| Mean LOS of each group | Compare the length of stay in ICU between the control and case groups. | 28 days | 
| Severity between groups using SAPS 3 | Compare the severity of disease between groups using the SAPS 3 score. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, Multi drug Resistant bacteria, Risk Factors, Critical Care, Score