NCT05314816

Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures in Pediatric Patients in Guatemala

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacteremia
• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood culture identification panel	multiplex PCR panel to be performed on positive blood cultures

Timeline

• Start date: 2022-04-07
• Primary completion: 2022-11-11
• Completion: 2022-11-28
• First posted: 2022-04-06
• Last updated: 2024-06-14
• Results posted: 2024-06-14

Locations

1 site across 1 country: Guatemala

Regulatory

• FDA-regulated device study