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Trial Outcomes & Findings for Duration of Antibiotic Treatment for Early VAP (DATE) Trial (NCT NCT01994980)

NCT ID: NCT01994980

Last Updated: 2023-01-10

Results Overview

Clinical Pulmonary Infection Score (CPIS) score. Scales of this score include Temperature, Blood Leukocytes, Tracheal Secretions, Oxygenation, Pulmonary Radiography, and Culture of Tracheal Aspirate. Each scale can have sub-scores ranging from 0-2, with a total CPIS score ranging from 0-12. In this outcome measure, higher scores mean worse functioning and risk for worse outcomes. Scores for the patients analyzed on this outcome measure were taken daily for 28 days and then averaged across that time point.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Daily for 28 days

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure
Default 4 Days Antibiotic Therapy
Default 4 days antibiotic therapy Default 4 days antibiotic therapy: The intervention for this trial involves a shorter duration of antibiotic therapy. Specifically, a default of 4 vs. 8 days.
Default 8 Days Antibiotic Therapy
Default 8 days of antibiotic therapy
Overall Study
STARTED
7
14
Overall Study
COMPLETED
7
14
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duration of Antibiotic Treatment for Early VAP (DATE) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Default 4 Days Antibiotic Therapy
n=7 Participants
Default 4 days antibiotic therapy Default 4 days antibiotic therapy: The intervention for this trial involves a shorter duration of antibiotic therapy. Specifically, a default of 4 vs. 8 days.
Default 8 Days Antibiotic Therapy
n=14 Participants
Default 8 days antibiotic therapy
Total
n=21 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
13 Participants
n=7 Participants
19 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
8 Participants
n=7 Participants
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
7 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Daily for 28 days

Population: CPIS score was averaged for separately for respective arms the day after treatment to see if there was any statistical difference.

Clinical Pulmonary Infection Score (CPIS) score. Scales of this score include Temperature, Blood Leukocytes, Tracheal Secretions, Oxygenation, Pulmonary Radiography, and Culture of Tracheal Aspirate. Each scale can have sub-scores ranging from 0-2, with a total CPIS score ranging from 0-12. In this outcome measure, higher scores mean worse functioning and risk for worse outcomes. Scores for the patients analyzed on this outcome measure were taken daily for 28 days and then averaged across that time point.

Outcome measures

Outcome measures
Measure
Default 4 Days Antibiotic Therapy
n=7 Participants
Default 4 days antibiotic therapy Default 4 days antibiotic therapy: The intervention for this trial involves a shorter duration of antibiotic therapy. Specifically, a default of 4 vs. 8 days.
Default 8 Days Antibiotic Therapy
n=11 Participants
Default 8 days antibiotic therapy
Clinical Response
2.9 score on a scale
Standard Deviation 1.2
2.9 score on a scale
Standard Deviation 1.5

Adverse Events

Default 4 Days Antibiotic Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Default 8 Days Antibiotic Therapy

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

Dr Fredric Pieracci

Denver Health

Phone: 303-436-4029

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place