Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Bacteremia; Sepsis

Treatments: Diagnostic Test: Blood culture identification panel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05314816

20-0464

Details and patient eligibility

About

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.

Full 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.

Enrollment: 479 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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479 participants in 3 patient groups

Blood culture identification panel

Experimental group

Description:

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

Treatment:

Diagnostic Test: Blood culture identification panel

Concurrent control

No Intervention group

Description:

Standard blood culture process will be performed concurrently on select positive blood culture specimens during the study period. BCID2 will NOT be performed on these specimens.

Retrospective control

No Intervention group

Description:

Standard blood culture process was performed prior to the study period.