Risk Factors for Multidrug Resistant Bacteria at ICU Admission

Multi Drug Resistant Bacteria Clinical Trial

Official title:

Risk Factors for Multidrug Resistant Bacteria at ICU Admission

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05983861
• Other study ID #: 17/2023
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: August 2023
• Source: Hospital Sao Domingos
• Contact: PAULO BEZERRA, MD
• Phone: +55 98988748865
• Email: drpaulobezerra[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multi Drug Resistant Bacteria

Intervention

Diagnostic Test:
• Identification o Multi Drug Resistant Bacteria
Identification o Multi Drug Resistant Bacteria

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
José Raimundo Araujo de Azevedo

References & Publications (7)

Bassetti M, Rello J, Blasi F, Goossens H, Sotgiu G, Tavoschi L, Zasowski EJ, Arber MR, McCool R, Patterson JV, Longshaw CM, Lopes S, Manissero D, Nguyen ST, Tone K, Aliberti S. Systematic review of the impact of appropriate versus inappropriate initial an — View Citation

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, Ce — View Citation

Fernandez-Martinez NF, Carcel-Fernandez S, De la Fuente-Martos C, Ruiz-Montero R, Guzman-Herrador BR, Leon-Lopez R, Gomez FJ, Guzman-Puche J, Martinez-Martinez L, Salcedo-Leal I. Risk Factors for Multidrug-Resistant Gram-Negative Bacteria Carriage upon Ad — View Citation

Kalil AC, Johnson DW, Lisco SJ, Sun J. Early Goal-Directed Therapy for Sepsis: A Novel Solution for Discordant Survival Outcomes in Clinical Trials. Crit Care Med. 2017 Apr;45(4):607-614. doi: 10.1097/CCM.0000000000002235. — View Citation

Liu VX, Fielding-Singh V, Greene JD, Baker JM, Iwashyna TJ, Bhattacharya J, Escobar GJ. The Timing of Early Antibiotics and Hospital Mortality in Sepsis. Am J Respir Crit Care Med. 2017 Oct 1;196(7):856-863. doi: 10.1164/rccm.201609-1848OC. — View Citation

Niederman MS, Baron RM, Bouadma L, Calandra T, Daneman N, DeWaele J, Kollef MH, Lipman J, Nair GB. Initial antimicrobial management of sepsis. Crit Care. 2021 Aug 26;25(1):307. doi: 10.1186/s13054-021-03736-w. — View Citation

Wong D, Wong T, Romney M, Leung V. Comparative effectiveness of beta-lactam versus vancomycin empiric therapy in patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. Ann Clin Microbiol Antimicrob. 2016 Apr 26;15:27. doi: 10.1186/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mean LOS of each group	Compare the length of stay in ICU between the control and case groups.	28 days
Secondary	Severity between groups using SAPS 3	Compare the severity of disease between groups using the SAPS 3 score.	28 days