Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

December 5, 2022 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Guatemala City, Guatemala
        • Hospital Roosevelt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood culture identification panel
BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens.
Diagnostic test: Blood culture identification panel
multiplex PCR panel to be performed on positive blood cultures
Other Names:
  • BCID2
  • BioFire BCID2 Panel
  • BioFire FilmArray
No Intervention: Concurrent control
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.
No Intervention: Retrospective control
Standard blood culture process was performed prior to the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to optimal antimicrobial therapy
Time Frame: 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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days
30 days
Time to organism identification
Time Frame: 14 days
Calculated from the time of blood culture draw to the time of organism identification.
14 days
Time to effective antimicrobial therapy
Time Frame: 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.
14 days
Length of hospital stay
Time Frame: 30 days
30 days
Intensive care unit days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

BioFire Diagnostics, LLC

Investigators

  • Principal Investigator: Samuel Dominguez, MD, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

November 28, 2022

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0464

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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