NCT05983861

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 2, 2023

Last Update Submit

August 2, 2023

Conditions

Multi Drug Resistant Bacteria

Keywords

InfectionMulti drug Resistant bacteriaRisk FactorsCritical CareScore

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Mortality between control and case group

    28 days

  • Mean LOS of each group

    28 days

  • Severity between groups using SAPS 3

    28 days

Study Arms (2)

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

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

Interventions

Identification o Multi Drug Resistant BacteriaDIAGNOSTIC_TEST

Identification o Multi Drug Resistant Bacteria

Multi drug resistant groupMulti sensible bacteria group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and a microbiological positive result for bacteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 34446092BACKGROUND

  • 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.

    PMID: 34605781RESULT

  • 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 antibiotic therapy on outcomes of patients with severe bacterial infections. Int J Antimicrob Agents. 2020 Dec;56(6):106184. doi: 10.1016/j.ijantimicag.2020.106184. Epub 2020 Oct 9.

    PMID: 33045353RESULT

  • 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.

    PMID: 28067711RESULT

  • 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.

    PMID: 28345952RESULT

  • 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/s12941-016-0143-3.

    PMID: 27112143RESULT

  • 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 Admission to the Intensive Care Unit. Int J Environ Res Public Health. 2022 Jan 18;19(3):1039. doi: 10.3390/ijerph19031039.

    PMID: 35162062RESULT

MeSH Terms

Conditions

Infections

Central Study Contacts

PAULO BEZERRA, MD

CONTACT

+55 98988748865drpaulobezerra@gmail.com

PEDRO FROTA, MD

CONTACT

+55 98999769456pedrohfrota@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ICU Assistent Physician

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 9, 2023

Study Start

September 1, 2023

Primary Completion

August 31, 2024

Study Completion

January 31, 2025

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share