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Risk Factors for Multidrug Resistant Bacteria at ICU Admission

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ClinicalTrials.gov Identifier: NCT05983861
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Multi Drug Resistant Bacteria Diagnostic Test: Identification o Multi Drug Resistant Bacteria

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

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Multidrug Resistant Bacteria at ICU Admission
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort Intervention/treatment
Multi drug resistant group
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
Identification o Multi Drug Resistant Bacteria
Multi sensible bacteria group
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


Outcome Measures
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Primary Outcome Measures :
  1. Determine risk factors for multi-drug resistant germs in ICU admission. [ Time Frame: 28 days ]
    Analysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance.


Secondary Outcome Measures :
  1. Mortality between control and case group [ Time Frame: 28 days ]
    Compare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria.

  2. Mean LOS of each group [ Time Frame: 28 days ]
    Compare the length of stay in ICU between the control and case groups.

  3. Severity between groups using SAPS 3 [ Time Frame: 28 days ]
    Compare the severity of disease between groups using the SAPS 3 score.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05983861


Contacts
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Contact: PAULO BEZERRA, MD +55 98988748865 drpaulobezerra@gmail.com
Contact: PEDRO FROTA, MD +55 98999769456 pedrohfrota@gmail.com

Sponsors and Collaborators
José Raimundo Araujo de Azevedo
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.

Other Publications:

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Responsible Party: José Raimundo Araujo de Azevedo, ICU Assistent Physician, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT05983861    
Other Study ID Numbers: 17/2023
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
Infection
Multi drug Resistant bacteria
Risk Factors
Critical Care
Score