Trial Outcomes & Findings for Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes (NCT NCT06069206)
NCT ID: NCT06069206
Last Updated: 2026-02-27
Results Overview
The time between randomization and the start time for the last dose of intravenous vancomycin received by the patient within 14 days of randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
Baseline to 14 days
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Usual Care
Patients will receive blood cultures and will not receive direct-from-blood testing.
|
Direct-from-blood Testing
In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria® Panel.
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
251
|
|
Overall Study
COMPLETED
|
249
|
251
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
43 patients did not have a complete blood count with differential at the time of enrollment.
Baseline characteristics by cohort
| Measure |
Usual Care
n=249 Participants
Patients will receive blood cultures and will not receive direct-from-blood testing.
|
Direct-from-blood Testing
n=251 Participants
In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria® Panel.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=249 Participants
|
57 years
n=251 Participants
|
57 years
n=500 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=249 Participants
|
110 Participants
n=251 Participants
|
224 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=249 Participants
|
141 Participants
n=251 Participants
|
276 Participants
n=500 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=249 Participants
|
4 Participants
n=251 Participants
|
5 Participants
n=500 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=249 Participants
|
0 Participants
n=251 Participants
|
0 Participants
n=500 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=249 Participants
|
0 Participants
n=251 Participants
|
0 Participants
n=500 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=249 Participants
|
48 Participants
n=251 Participants
|
89 Participants
n=500 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=249 Participants
|
175 Participants
n=251 Participants
|
354 Participants
n=500 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=249 Participants
|
0 Participants
n=251 Participants
|
0 Participants
n=500 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=249 Participants
|
24 Participants
n=251 Participants
|
52 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=249 Participants
|
10 Participants
n=251 Participants
|
26 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=249 Participants
|
229 Participants
n=251 Participants
|
453 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=249 Participants
|
12 Participants
n=251 Participants
|
21 Participants
n=500 Participants
|
|
Body Mass Index
|
27 kg/m²
n=249 Participants
|
26 kg/m²
n=251 Participants
|
26.5 kg/m²
n=500 Participants
|
|
Sepsis
|
77 Participants
n=249 Participants
|
103 Participants
n=251 Participants
|
180 Participants
n=500 Participants
|
|
SOFA score ≥ 2
|
47 Participants
n=249 Participants
|
31 Participants
n=251 Participants
|
78 Participants
n=500 Participants
|
|
Suspected source of infection
Lung
|
46 Participants
n=249 Participants
|
69 Participants
n=251 Participants
|
115 Participants
n=500 Participants
|
|
Suspected source of infection
Intra-abdominal
|
39 Participants
n=249 Participants
|
24 Participants
n=251 Participants
|
63 Participants
n=500 Participants
|
|
Suspected source of infection
Genitourinary
|
17 Participants
n=249 Participants
|
20 Participants
n=251 Participants
|
37 Participants
n=500 Participants
|
|
Suspected source of infection
Skin/soft tissue
|
53 Participants
n=249 Participants
|
55 Participants
n=251 Participants
|
108 Participants
n=500 Participants
|
|
Suspected source of infection
Other
|
31 Participants
n=249 Participants
|
36 Participants
n=251 Participants
|
67 Participants
n=500 Participants
|
|
Suspected source of infection
Unknown
|
63 Participants
n=249 Participants
|
47 Participants
n=251 Participants
|
110 Participants
n=500 Participants
|
|
Transplant recipient
|
21 Participants
n=249 Participants
|
22 Participants
n=251 Participants
|
43 Participants
n=500 Participants
|
|
Neutropenia
|
10 Participants
n=223 Participants • 43 patients did not have a complete blood count with differential at the time of enrollment.
|
12 Participants
n=234 Participants • 43 patients did not have a complete blood count with differential at the time of enrollment.
|
22 Participants
n=457 Participants • 43 patients did not have a complete blood count with differential at the time of enrollment.
|
|
Chronic kidney disease
|
55 Participants
n=249 Participants
|
45 Participants
n=251 Participants
|
100 Participants
n=500 Participants
|
|
End-stage kidney disease on Kidney Replacement Therapy
|
22 Participants
n=249 Participants
|
10 Participants
n=251 Participants
|
32 Participants
n=500 Participants
|
|
Baseline creatinine
Pre-illness
|
0.76 mg/dL
n=249 Participants
|
0.75 mg/dL
n=251 Participants
|
0.76 mg/dL
n=500 Participants
|
|
Baseline creatinine
Peri-enrollment
|
1.05 mg/dL
n=249 Participants
|
1.07 mg/dL
n=251 Participants
|
1.06 mg/dL
n=500 Participants
|
|
Charlson Comorbidity Index
|
4 Index
n=241 Participants • Charlson Comorbidity Index data is missing for 18 patients (10 patients in the direct-from-blood-test group, 8 patients in the usual care group).
|
4 Index
n=241 Participants • Charlson Comorbidity Index data is missing for 18 patients (10 patients in the direct-from-blood-test group, 8 patients in the usual care group).
|
4 Index
n=482 Participants • Charlson Comorbidity Index data is missing for 18 patients (10 patients in the direct-from-blood-test group, 8 patients in the usual care group).
|
|
Minutes from hospital presentation to enrollment
|
26.5 Minutes
n=249 Participants • Minutes from hospital presentation to enrollment was missing for one participant in the direct-from-blood test group.
|
37.8 Minutes
n=250 Participants • Minutes from hospital presentation to enrollment was missing for one participant in the direct-from-blood test group.
|
33 Minutes
n=499 Participants • Minutes from hospital presentation to enrollment was missing for one participant in the direct-from-blood test group.
|
|
Admission to ICU during index encounter
|
70 Participants
n=249 Participants
|
73 Participants
n=251 Participants
|
143 Participants
n=500 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14 daysThe time between randomization and the start time for the last dose of intravenous vancomycin received by the patient within 14 days of randomization.
Outcome measures
| Measure |
Usual Care
n=249 Participants
Patients will receive blood cultures and will not receive direct-from-blood testing.
|
Direct-from-blood Testing
n=251 Participants
In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria® Panel.
|
|---|---|---|
|
Time to Last Dose of Intravenous Vancomycin
|
19.0 time in hours
Interval 0.9 to 64.8
|
12.5 time in hours
Interval 0.79 to 57.8
|
SECONDARY outcome
Timeframe: Baseline to 14 daysThe time between randomization and start time of the last dose of systemic anti-pseudomonal beta-lactam antibiotic received by the patient within 14 days of randomization.
Outcome measures
| Measure |
Usual Care
n=249 Participants
Patients will receive blood cultures and will not receive direct-from-blood testing.
|
Direct-from-blood Testing
n=251 Participants
In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria® Panel.
|
|---|---|---|
|
Time to Last Dose of Systemic Anti-pseudomonal Beta-lactam Antibiotic
|
1.7 time in days
Interval 0.05 to 3.8
|
1.6 time in days
Interval 0.04 to 3.6
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Direct-from-blood Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matthew Semler, MD, MSCI
Vanderbilt University Medical Center
Phone: 615-835-9870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place