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Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904995
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : May 12, 2011
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Fungal Infection
Intervention Drug: Voriconazole
Enrollment 23
Recruitment Details Recruitment Period: 4/2/09 to 8/19/09. All participants registered at The University of Texas M.D. Anderson Cancer Center.
Pre-assignment Details Two of the twenty-three participants registered withdrew prior to their assignment to groups.
Arm/Group Title Group 1 - Oral Group 2 - IV + Oral
Hide Arm/Group Description Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter. Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
Period Title: Overall Study
Started 10 11
Completed 10 11
Not Completed 0 0
Arm/Group Title Group 1 - Oral Group 2 - IV + Oral Total
Hide Arm/Group Description Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter. Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter. Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
52
(25 to 78)
61
(20 to 76)
56
(20 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
7
  70.0%
5
  45.5%
12
  57.1%
Male
3
  30.0%
6
  54.5%
9
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 21 participants
10 11 21
1.Primary Outcome
Title Percentage of Samples With BG Levels > 60pg/ml
Hide Description

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.

Time Frame Up to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.
Arm/Group Title Group 1 - Oral Group 2 - IV + Oral
Hide Arm/Group Description:
Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
Overall Number of Participants Analyzed 10 11
Overall Number of Units Analyzed
Type of Units Analyzed: Blood samples
87 95
Measure Type: Number
Unit of Measure: percent of blood samples
Samples BG levels > 60pg/ml, First Test 4 5
Samples BG levels > 60pg/ml, Following Re-Test 3 3
Time Frame 1 year 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 - Oral Group 2 - IV + Oral
Hide Arm/Group Description Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter. Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
All-Cause Mortality
Group 1 - Oral Group 2 - IV + Oral
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group 1 - Oral Group 2 - IV + Oral
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 - Oral Group 2 - IV + Oral
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jorge Cortes, MD / Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-745-5783
EMail: eharrison@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00904995    
Other Study ID Numbers: 2008-0443
First Submitted: May 18, 2009
First Posted: May 20, 2009
Results First Submitted: April 18, 2011
Results First Posted: May 12, 2011
Last Update Posted: August 7, 2012