Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314816
• Other study ID #: 20-0464
• Status: Completed
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: November 28, 2022

Study information

• Verified date: June 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: November 28, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Sepsis

Intervention

Diagnostic Test:
• Blood culture identification panel
multiplex PCR panel to be performed on positive blood cultures

Locations

Country	Name	City	State
Guatemala	Hospital Roosevelt	Guatemala City

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	BioFire Diagnostics, LLC

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Optimal Antimicrobial Therapy	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.	14 days
Secondary	Time to Organism Identification	Calculated from the time of blood culture draw to the time of organism identification.	14 days
Secondary	Time to Effective Antimicrobial Therapy	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.	14 days
Secondary	All-cause Mortality	30 day mortality	30 days
Secondary	Length of Hospital Stay		30 days
Secondary	Intensive Care Unit Days	Days in the ICU	30 days