Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

Not Applicable

Completed

• Conditions: Bacteremia; Sepsis
• Interventions: Diagnostic Test: Blood culture identification panel

• Registration Number: NCT05314816
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in Guatemala City.

Detailed Description

A retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in Guatemala City. These will serve as retrospective controls. The prospective portion of this study will implement the BioFire FilmArray blood culture identification panel (BCID2). Laboratory technicians will perform BCID2 simultaneously with standard culture after it flags positive on the automated blood culture system. BCID2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. Those specimens that become positive overnight will not have the BCID2 performed and will serve as concurrent controls. Physicians will be notified of panel results for the BCID2 intervention group and standard culture results per current laboratory protocol. This study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups.

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Study Start: 2022-04-07
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-28
• Results First Submitted: 2024-02-06
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Results First Posted: 2024-06-14
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

Inclusion Criteria

• Age <18 years of age
• First positive blood culture during the hospitalization

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Exclusion Criteria

• Non-blood specimens
• Repeat positive blood cultures from the same admission
• Patients who expire prior to positive culture
• Outpatient blood cultures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood culture identification panel	Blood culture identification panel	BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens.

Primary Outcome Measures

Name	Time	Method
Time to Optimal Antimicrobial Therapy	14 days	Calculated from the time of blood culture draw to the time that optimal antimicrobial therapy is started. Optimal antimicrobial therapy is defined based on pre-determined organism-antimicrobial guidelines.

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	30 days	30 day mortality
Time to Effective Antimicrobial Therapy	14 days	Calculated from the time of blood culture draw to the time that the effective therapy is started. Effective therapy is determined based on susceptibilities of the organism.
Intensive Care Unit Days	30 days	Days in the ICU
Time to Organism Identification	14 days	Calculated from the time of blood culture draw to the time of organism identification.
Length of Hospital Stay	30 days

Trial Locations

Locations (1)

Hospital Roosevelt; 🇬🇹 Guatemala City, Guatemala