Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bacteremia, Sepsis

Intervention / Treatment
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* Diagnostic Test: Blood culture identification panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood culture identification panel<br>BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens. | Diagnostic Test: Blood culture identification panel<br>* multiplex PCR panel to be performed on positive blood cultures<br>* Other names: BioFire FilmArray;|
| No Intervention: Concurrent control<br>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<br>Standard blood culture process was performed prior to the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacteremia, sepsis, antimicrobial resistance, BCID2, multiplex PCR, pediatric