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Completed

NCT Number: NCT05314816

Rapid Blood Culture Identification Panel 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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Roosevelt

Guatemala City, Guatemala

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood culture identification panel

Diagnostic Test

multiplex PCR panel to be performed on positive blood cultures

Other names: BCID2, BioFire BCID2 Panel, BioFire FilmArray

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to Organism Identification

    Time frame: 14 days

    Calculated from the time of blood culture draw to the time of organism identification.

  2. 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.

  3. All-cause Mortality

    Time frame: 30 days

    30 day mortality

  4. Length of Hospital Stay

    Time frame: 30 days

  5. Intensive Care Unit Days

    Time frame: 30 days

    Days in the ICU

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • BioFire Diagnostics, LLC

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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