BacteremiaNCT05314816
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
A study testing Blood culture identification panel in people with Bacteremia and Sepsis, run by University of Colorado, Denver at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bacteremia, Sepsis
- What is being tested?
- Blood culture identification panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 1 siteGuatemala
- Study dates
- 7 Apr 2022to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age <18 years of age
- First positive blood culture during the hospitalization
Who cannot join
- Non-blood specimens
- Repeat positive blood cultures from the same admission
- Patients who expire prior to positive culture
- Outpatient blood cultures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures 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.
Read the detailed description
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
- Bacteremia, Sepsis
- Being tested
- Blood culture identification panel
- Keywords
- bacteremia, sepsis, antimicrobial resistance, BCID2, multiplex PCR, pediatric
- Medical subject headings
- Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood culture identification panelDiagnostic test
Also called BCID2, BioFire BCID2 Panel, BioFire FilmArray
multiplex PCR panel to be performed on positive blood cultures
| Study group | Role | What they receive |
|---|---|---|
| Blood culture identification panel | Experimental | BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (5)
Time to Organism Identification
Calculated from the time of blood culture draw to the time of organism identification.
Measured: 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.
Measured: 14 days
All-cause Mortality
30 day mortality
Measured: 30 days
Length of Hospital Stay
Measured: 30 days
Intensive Care Unit Days
Days in the ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start7 Apr 2022
- Primary completion11 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Responsible party
- Sponsor
- Investigators
- Samuel Dominguez, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314816
- Sponsor's protocol ID
- 20-0464
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2022
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40880253
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures in Pediatric Patients in Guatemala
- ClinicalTrials.gov ID
- NCT05314816
- Acronym / sponsor ID
- 20-0464
- Conditions
- Bacteremia, Sepsis
- Keywords
- bacteremia, sepsis, antimicrobial resistance, BCID2, multiplex PCR, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood culture identification panel | Experimental | Diagnostic Test: Blood culture identification panelBioFire 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age <18 years of age
- First positive blood culture during the hospitalization
Key exclusion criteria (4 listed)
- Non-blood specimens
- Repeat positive blood cultures from the same admission
- Patients who expire prior to positive culture
- Outpatient blood cultures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood culture identification panelAlso: BCID2, BioFire BCID2 Panel, BioFire FilmArraymultiplex PCR panel to be performed on positive blood cultures | Diagnostic test | Blood culture identification panel |
Primary outcome
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.
5 secondary outcomes
Time to Organism Identification
Time frame: 14 days
Time to Effective Antimicrobial Therapy
Time frame: 14 days
All-cause Mortality
Time frame: 30 days
Length of Hospital Stay
Time frame: 30 days
Intensive Care Unit Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40880253Graff 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Dominguez, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood culture identification panel in people with Bacteremia and Sepsis, run by University of Colorado, Denver at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Optimal Antimicrobial Therapy (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.