NCT05314816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 14, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

March 29, 2022

Results QC Date

February 6, 2024

Last Update Submit

June 13, 2024

Conditions

BacteremiaSepsis

Keywords

bacteremiasepsisantimicrobial resistanceBCID2multiplex PCRpediatric

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Time to Organism Identification

    14 days

  • Time to Effective Antimicrobial Therapy

    14 days

  • All-cause Mortality

    30 days

  • Length of Hospital Stay

    30 days

  • Intensive Care Unit Days

    30 days

Study Arms (3)

Blood culture identification panel

EXPERIMENTAL

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

Diagnostic Test: Blood culture identification panel

Concurrent control

NO INTERVENTION

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

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

Interventions

Blood culture identification panelDIAGNOSTIC_TEST

multiplex PCR panel to be performed on positive blood cultures

Also known as: BCID2, BioFire BCID2 Panel, BioFire FilmArray
Blood culture identification panel

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Roosevelt

Guatemala City, Guatemala

Location

Related Publications (1)

  • Graff KE, Galvez N, Lamb MM, Cortes R, Sanchez Villeda EA, Calvimontes DM, Melgar MA, Olson D, Asturias EJ, Dominguez SR. Evaluating the Clinical Impact of the BCID2 Panel and Antimicrobial Stewardship in Pediatric Bloodstream Infections: A Pragmatic Trial in Guatemala. Pediatr Infect Dis J. 2025 Nov 1;44(11):1051-1058. doi: 10.1097/INF.0000000000004937. Epub 2025 Aug 1.

    PMID: 40880253DERIVED

MeSH Terms

Conditions

BacteremiaSepsis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Kelly Graff
Organization
Medical College of Wisconsin
kegraff@mcw.edu
414-266-4123

Study Officials

  • Samuel Dominguez, MD, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

April 7, 2022

Primary Completion

November 11, 2022

Study Completion

November 28, 2022

Last Updated

June 14, 2024

Results First Posted

June 14, 2024

Record last verified: 2024-06

Locations

GU(1)