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| Name | Class |
|---|---|
| BioFire Diagnostics, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood culture identification panel | Experimental | BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood culture identification panel | Diagnostic Test | multiplex PCR panel to be performed on positive blood cultures |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Dominguez, MD, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Roosevelt | Guatemala City | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40880253 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Culture Identification Panel | BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens. Blood culture identification panel: multiplex PCR panel to be performed on positive blood cultures |
| FG001 | 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. |
| FG002 | Retrospective Control | Standard blood culture process was performed prior to the study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Culture Identification Panel | BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens. Blood culture identification panel: multiplex PCR panel to be performed on positive blood cultures |
| BG001 | Concurrent Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis. | Posted | Median | Inter-Quartile Range | hours | 14 days |
|
30 days
452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Culture Identification Panel | BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens. Blood culture identification panel: multiplex PCR panel to be performed on positive blood cultures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Graff | Medical College of Wisconsin | 414-266-4123 | kegraff@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2022 | Feb 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2023 | Feb 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
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| 14 days |
| All-cause Mortality | 30 day mortality | 30 days |
| Length of Hospital Stay | 30 days |
| Intensive Care Unit Days | Days in the ICU | 30 days |
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. |
| BG002 | Retrospective Control | Standard blood culture process was performed prior to the study period. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Antecedent medical conditions | Count of Participants | Participants |
|
| Central line | Count of Participants | Participants |
|
| ICU stay | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Retrospective Control | Standard blood culture process was performed prior to the study period. |
|
|
| Secondary | Time to Organism Identification | Calculated from the time of blood culture draw to the time of organism identification. | 452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis. | Posted | Median | Inter-Quartile Range | hours | 14 days |
|
|
|
| Secondary | 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. | 452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis. | Posted | Median | Inter-Quartile Range | hours | 14 days |
|
|
|
| Secondary | All-cause Mortality | 30 day mortality | 452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Length of Hospital Stay | 452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis. | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
| Secondary | Intensive Care Unit Days | Days in the ICU | 452 patients completed the study and were analyzed. Note that 6 patients were originally enrolled in the BCID group, but ultimately analyzed in the concurrent control group as they did not receive the intervention as allocated. These 6 patients crossed over from the BCID group into the concurrent control group for the analysis, leaving 135 in the BCID and 219 in the concurrent control group for the analysis. | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
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| 14 |
| 135 |
| 0 |
| 135 |
| 0 |
| 135 |
| EG001 | 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. | 30 | 219 | 0 | 219 | 0 | 219 |
| EG002 | Retrospective Control | Standard blood culture process was performed prior to the study period. | 18 | 98 | 0 | 98 | 0 | 98 |
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| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
|
|