Trial Outcomes & Findings for Negative Beta Glucan in ICU Patients (NCT NCT01734525)
NCT ID: NCT01734525
Last Updated: 2019-07-08
Results Overview
The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
85 participants
Primary outcome timeframe
30 days
Results posted on
2019-07-08
Participant Flow
Participant milestones
| Measure |
Anidulafungin
Patients at risk will receive therapy with anidulafungin
Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
|
|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Negative Beta Glucan in ICU Patients
Baseline characteristics by cohort
| Measure |
Anidulafungin
n=85 Participants
Patients at risk will receive therapy with anidulafungin
Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
Outcome measures
| Measure |
Anidulafungin
n=21 Participants
Patients at risk will receive therapy with anidulafungin
Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
|
|---|---|
|
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
No candidemia
|
21 Participants
|
|
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
Candidemia
|
0 Participants
|
Adverse Events
One Arm
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