Trial Outcomes & Findings for Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea (NCT NCT03809117)
NCT ID: NCT03809117
Last Updated: 2022-12-20
Results Overview
Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
30 Days post ED Discharge
Results posted on
2022-12-20
Participant Flow
Participant milestones
| Measure |
Experimental
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Control
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
Baseline characteristics by cohort
| Measure |
Experimental
n=38 Participants
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Control
n=36 Participants
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
33 years
n=7 Participants
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian, Native American, Other, Unknown
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 Days post ED DischargeOptimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.
Outcome measures
| Measure |
Experimental
n=38 Participants
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Control
n=36 Participants
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
|---|---|---|
|
Number of Participants With Optimal Antibiotic Chosen
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 Days post ED DischargeTime from patient arrival to time when patient is officially discharged or admitted
Outcome measures
| Measure |
Experimental
n=38 Participants
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Control
n=36 Participants
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
|---|---|---|
|
ED Length of Stay
|
7.68 hours
Interval 6.43 to 10.67
|
8.15 hours
Interval 5.9 to 11.23
|
SECONDARY outcome
Timeframe: 30 Days post ED DischargeOutcome measures
| Measure |
Experimental
n=38 Participants
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Control
n=36 Participants
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
|---|---|---|
|
Hospital Admission Rate
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 Days post ED DischargeOutcome measures
| Measure |
Experimental
n=38 Participants
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
Control
n=36 Participants
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
|
|---|---|---|
|
Rate of Abdominal/Pelvic CT Scans
|
8 Participants
|
8 Participants
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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