Trial Outcomes & Findings for Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis (NCT NCT00904995)
NCT ID: NCT00904995
Last Updated: 2012-08-07
Results Overview
Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI). Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity.
COMPLETED
PHASE3
23 participants
Up to 42 days
2012-08-07
Participant Flow
Recruitment Period: 4/2/09 to 8/19/09. All participants registered at The University of Texas M.D. Anderson Cancer Center.
Two of the twenty-three participants registered withdrew prior to their assignment to groups.
Participant milestones
| Measure |
Group 1 - Oral
Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
|
Group 2 - IV + Oral
Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
Baseline characteristics by cohort
| Measure |
Group 1 - Oral
n=10 Participants
Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
|
Group 2 - IV + Oral
n=11 Participants
Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52 years
n=5 Participants
|
61 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.
Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI). Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity.
Outcome measures
| Measure |
Group 1 - Oral
n=87 Blood samples
Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
|
Group 2 - IV + Oral
n=95 Blood samples
Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
|
|---|---|---|
|
Percentage of Samples With BG Levels > 60pg/ml
Samples BG levels > 60pg/ml, First Test
|
4 percent of blood samples
|
5 percent of blood samples
|
|
Percentage of Samples With BG Levels > 60pg/ml
Samples BG levels > 60pg/ml, Following Re-Test
|
3 percent of blood samples
|
3 percent of blood samples
|
Adverse Events
Group 1 - Oral
Group 2 - IV + Oral
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jorge Cortes, MD / Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place