Bacteremia, Sepsis
Conditions
Keywords
bacteremia, sepsis, antimicrobial resistance, BCID2, multiplex PCR, pediatric
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTBlood culture identification panel
multiplex PCR panel to be performed on positive blood cultures
Sponsors
BioFire Diagnostics, LLC
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Optimal Antimicrobial Therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 30 days | — |
| Intensive Care Unit Days | 30 days | Days in the ICU |
| Time to Organism Identification | 14 days | Calculated from the time of blood culture draw to the time of organism identification. |
| Time to Effective Antimicrobial Therapy | 14 days | 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. |
| All-cause Mortality | 30 days | 30 day mortality |
Countries
Guatemala
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 135 |
| 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. | 219 |
| Retrospective Control Standard blood culture process was performed prior to the study period. | 98 |
| Total | 452 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 | 1 |
| Overall Study | Protocol Violation | 13 | 8 | 0 |
Baseline characteristics
| Characteristic | Blood Culture Identification Panel | Concurrent Control | Retrospective Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 135 Participants | 219 Participants | 98 Participants | 452 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1 months | 1 months | 0 months | 0.9 months |
| Antecedent medical conditions No antecedent medical conditions | 70 Participants | 114 Participants | 25 Participants | 209 Participants |
| Antecedent medical conditions One or more medical condition | 65 Participants | 105 Participants | 73 Participants | 243 Participants |
| Central line | 67 Participants | 132 Participants | 70 Participants | 269 Participants |
| ICU stay | 68 Participants | 133 Participants | 73 Participants | 274 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Guatemala | 135 participants | 219 participants | 98 participants | 452 participants |
| Sex: Female, Male Female | 61 Participants | 99 Participants | 36 Participants | 196 Participants |
| Sex: Female, Male Male | 74 Participants | 120 Participants | 62 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 135 | 30 / 219 | 18 / 98 |
| other Total, other adverse events | 0 / 135 | 0 / 219 | 0 / 98 |
| serious Total, serious adverse events | 0 / 135 | 0 / 219 | 0 / 98 |
Outcome results
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.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Culture Identification Panel | Time to Optimal Antimicrobial Therapy | 31.1 hours |
| Concurrent Control | Time to Optimal Antimicrobial Therapy | 117.7 hours |
| Retrospective Control | Time to Optimal Antimicrobial Therapy | 90.0 hours |
Secondary
All-cause Mortality
30 day mortality
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Culture Identification Panel | All-cause Mortality | 14 Participants |
| Concurrent Control | All-cause Mortality | 30 Participants |
| Retrospective Control | All-cause Mortality | 18 Participants |
Secondary
Intensive Care Unit Days
Days in the ICU
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Culture Identification Panel | Intensive Care Unit Days | 14.3 days |
| Concurrent Control | Intensive Care Unit Days | 14.8 days |
| Retrospective Control | Intensive Care Unit Days | 9.0 days |
Secondary
Length of Hospital Stay
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Culture Identification Panel | Length of Hospital Stay | 17 days |
| Concurrent Control | Length of Hospital Stay | 20 days |
| Retrospective Control | Length of Hospital Stay | 17 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.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Culture Identification Panel | Time to Effective Antimicrobial Therapy | 0 hours |
| Concurrent Control | Time to Effective Antimicrobial Therapy | 0.2 hours |
| Retrospective Control | Time to Effective Antimicrobial Therapy | 3.0 hours |
Secondary
Time to Organism Identification
Calculated from the time of blood culture draw to the time of organism identification.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Culture Identification Panel | Time to Organism Identification | 22.6 hours |
| Concurrent Control | Time to Organism Identification | 79.8 hours |
| Retrospective Control | Time to Organism Identification | 76.8 hours |