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Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

Primary Purpose

Bacteremia, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
Blood culture identification panel
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bacteremia focused on measuring bacteremia, sepsis, antimicrobial resistance, BCID2, multiplex PCR, pediatric

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Roosevelt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Blood culture identification panel

Concurrent control

Retrospective control

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to organism identification
Calculated from the time of blood culture draw to the time of organism identification.
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.
All-cause mortality
Length of hospital stay
Intensive care unit days

Full Information

First Posted
March 29, 2022
Last Updated
December 5, 2022
Sponsor
University of Colorado, Denver
Collaborators
BioFire Diagnostics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05314816
Brief Title
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
Official Title
Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures in Pediatric Patients in Guatemala
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
BioFire Diagnostics, LLC

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia, Sepsis
Keywords
bacteremia, sepsis, antimicrobial resistance, BCID2, multiplex PCR, pediatric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood culture identification panel
Arm Type
Experimental
Arm Description
BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens.
Arm Title
Concurrent control
Arm Type
No Intervention
Arm 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.
Arm Title
Retrospective control
Arm Type
No Intervention
Arm Description
Standard blood culture process was performed prior to the study period.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood culture identification panel
Other Intervention Name(s)
BCID2, BioFire BCID2 Panel, BioFire FilmArray
Intervention Description
multiplex PCR panel to be performed on positive blood cultures
Primary Outcome Measure Information:
Title
Time to optimal antimicrobial therapy
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time to organism identification
Description
Calculated from the time of blood culture draw to the time of organism identification.
Time Frame
14 days
Title
Time to effective antimicrobial therapy
Description
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.
Time Frame
14 days
Title
All-cause mortality
Time Frame
30 days
Title
Length of hospital stay
Time Frame
30 days
Title
Intensive care unit days
Time Frame
30 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Dominguez, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Roosevelt
City
Guatemala City
Country
Guatemala

12. IPD Sharing Statement

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Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

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