Trial Outcomes & Findings for Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala (NCT NCT05314816)
NCT ID: NCT05314816
Last Updated: 2024-06-14
Results Overview
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.
COMPLETED
NA
479 participants
14 days
2024-06-14
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
Retrospective Control
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
159
|
221
|
99
|
|
Overall Study
Analyzed in Concurrent Control Group
|
6
|
0
|
0
|
|
Overall Study
COMPLETED
|
141
|
213
|
98
|
|
Overall Study
NOT COMPLETED
|
18
|
8
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
Retrospective Control
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
1
|
|
Overall Study
Protocol Violation
|
13
|
8
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
135 Participants
n=135 Participants
|
219 Participants
n=219 Participants
|
98 Participants
n=98 Participants
|
452 Participants
n=452 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=135 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=452 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=135 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=452 Participants
|
|
Age, Continuous
|
1 months
n=135 Participants
|
1 months
n=219 Participants
|
0 months
n=98 Participants
|
0.9 months
n=452 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=135 Participants
|
99 Participants
n=219 Participants
|
36 Participants
n=98 Participants
|
196 Participants
n=452 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=135 Participants
|
120 Participants
n=219 Participants
|
62 Participants
n=98 Participants
|
256 Participants
n=452 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Guatemala
|
135 participants
n=135 Participants
|
219 participants
n=219 Participants
|
98 participants
n=98 Participants
|
452 participants
n=452 Participants
|
|
Antecedent medical conditions
No antecedent medical conditions
|
70 Participants
n=135 Participants
|
114 Participants
n=219 Participants
|
25 Participants
n=98 Participants
|
209 Participants
n=452 Participants
|
|
Antecedent medical conditions
One or more medical condition
|
65 Participants
n=135 Participants
|
105 Participants
n=219 Participants
|
73 Participants
n=98 Participants
|
243 Participants
n=452 Participants
|
|
Central line
|
67 Participants
n=135 Participants
|
132 Participants
n=219 Participants
|
70 Participants
n=98 Participants
|
269 Participants
n=452 Participants
|
|
ICU stay
|
68 Participants
n=135 Participants
|
133 Participants
n=219 Participants
|
73 Participants
n=98 Participants
|
274 Participants
n=452 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Time to Optimal Antimicrobial Therapy
|
31.1 hours
Interval 0.0 to 150.0
|
117.7 hours
Interval 0.0 to 248.4
|
90.0 hours
Interval 4.3 to 158.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 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.
Calculated from the time of blood culture draw to the time of organism identification.
Outcome measures
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Time to Organism Identification
|
22.6 hours
Interval 20.3 to 28.0
|
79.8 hours
Interval 61.7 to 104.5
|
76.8 hours
Interval 66.9 to 91.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Time to Effective Antimicrobial Therapy
|
0 hours
Interval 0.0 to 33.9
|
0.2 hours
Interval 0.0 to 120.2
|
3.0 hours
Interval 0.0 to 89.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
30 day mortality
Outcome measures
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
All-cause Mortality
|
14 Participants
|
30 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
Outcome measures
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Length of Hospital Stay
|
17 days
Interval 11.0 to 30.0
|
20 days
Interval 11.0 to 30.0
|
17 days
Interval 10.0 to 30.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
Days in the ICU
Outcome measures
| Measure |
Blood Culture Identification Panel
n=135 Participants
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
|
Concurrent Control
n=219 Participants
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
n=98 Participants
Standard blood culture process was performed prior to the study period.
|
|---|---|---|---|
|
Intensive Care Unit Days
|
14.3 days
Interval 7.5 to 26.2
|
14.8 days
Interval 8.5 to 28.0
|
9.0 days
Interval 6.0 to 15.5
|
Adverse Events
Blood Culture Identification Panel
Concurrent Control
Retrospective Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place