Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

479 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2022-11-28

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.

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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.

Conditions

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Bacteremia Sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood culture identification panel

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

Group Type EXPERIMENTAL

Blood culture identification panel

Intervention Type DIAGNOSTIC_TEST

multiplex PCR panel to be performed on positive blood cultures

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Retrospective control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Blood culture identification panel

multiplex PCR panel to be performed on positive blood cultures

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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BCID2 BioFire BCID2 Panel BioFire FilmArray

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No