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Risk Factors for Multidrug Resistant Bacteria at ICU Admission

Risk Factors for Multidrug Resistant Bacteria at ICU Admission

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05983861
Enrollment
400
Registered
2023-08-09
Start date
2023-09-01
Completion date
2025-01-31
Last updated
2023-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multi Drug Resistant Bacteria

Keywords

Infection, Multi drug Resistant bacteria, Risk Factors, Critical Care, Score

Brief summary

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

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

Interventions

DIAGNOSTIC_TESTIdentification o Multi Drug Resistant Bacteria

Identification o Multi Drug Resistant Bacteria

Sponsors

José Raimundo Araujo de Azevedo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Determine risk factors for multi-drug resistant germs in ICU admission.28 daysAnalysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance.

Secondary

MeasureTime frameDescription
Mortality between control and case group28 daysCompare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria.
Mean LOS of each group28 daysCompare the length of stay in ICU between the control and case groups.
Severity between groups using SAPS 328 daysCompare the severity of disease between groups using the SAPS 3 score.

Contacts

Primary ContactPAULO BEZERRA, MD
drpaulobezerra@gmail.com+55 98988748865
Backup ContactPEDRO FROTA, MD
pedrohfrota@gmail.com+55 98999769456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026