An observational study in Multi Drug Resistant Bacteria, sponsored by José Raimundo Araujo de Azevedo. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by José Raimundo Araujo de Azevedo · Observational
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.
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
6,702 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's planned enrollment of 400 is above the median of 240 across 2,144 observational studies indexed under Infections.
Browse Infections studies →José Raimundo Araujo de Azevedo is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Adult patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result.
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Exclusion Criteria:
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
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
Identification o Multi Drug Resistant Bacteria
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.
Time frame: 28 days
Mortality between control and case group
Compare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria.
Time frame: 28 days
Mean LOS of each group
Compare the length of stay in ICU between the control and case groups.
Time frame: 28 days
Severity between groups using SAPS 3
Compare the severity of disease between groups using the SAPS 3 score.
Time frame: 28 days
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2023; primary completion for Aug 2024, 11 months later.
Of 789 non-industry observational studies under Infections, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 11 months is below that.
Counting every sponsor, half of 875 studies reached it within 25 months; a quarter within 12 and three quarters within 53.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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José Raimundo Araujo de Azevedo