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Trial record 52 of 201 for:    aspergillosis

An Observational Study of Fungal Biomarkers (MK-0000-089)

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: NCT00854607
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : August 28, 2012
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Aspergillosis
Intervention Other: No Intervention
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Invasive Aspergillosis
Hide Arm/Group Description Participants who enrolled with a presumptive diagnosis of possible, probable or proven Invasive Aspergillosis (IA) infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
Period Title: Enrollment
Started 116
Completed 116
Not Completed 0
Period Title: 2 Weeks After Start Anti-fungal Therapy
Started 116
Completed 51
Not Completed 65
Reason Not Completed
Diagnosed with Possible IA             65
Arm/Group Title Invasive Aspergillosis
Hide Arm/Group Description Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
56.9  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
18
  35.3%
Male
33
  64.7%
1.Primary Outcome
Title Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD). The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and whose clinical outcome was determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.20  (1.32) -0.09  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments One-Sided P-value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 90%
-0.20 to 0.77
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
-0.09  (1.37) 0.08  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments One-Sided P-value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 90%
-0.65 to 0.30
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.07  (0.26) -0.12  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 90%
-0.06 to 0.44
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.02  (1.06) -0.00  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference Between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.42 to 0.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
-0.24  (1.71) 0.08  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval (2-Sided) 90%
-0.87 to 0.23
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.10  (0.30) -0.09  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 90%
-0.09 to 0.46
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.31  (1.40) -0.16  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.47
Confidence Interval (2-Sided) 90%
-0.01 to 0.96
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.25  (1.40) 0.04  (1.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 90%
-0.41 to 0.83
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.41  (1.61) 0.01  (1.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 90%
-0.27 to 1.08
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.05  (0.14) -0.10  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 90%
-0.02 to 0.32
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.08  (0.17) -0.10  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 90%
-0.03 to 0.38
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 through 6
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.27  (1.53) -0.12  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 90%
-0.13 to 0.91
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 through 6
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
0.49  (1.75) -0.16  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Confidence Interval (2-Sided) 90%
0.09 to 1.22
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 through 6
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
-0.08  (1.40) 0.08  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments One-Sided P-value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 90%
-0.63 to 0.32
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Hide Description After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
Time Frame Weeks 1 through 6
Hide Outcome Measure Data
Hide Analysis Population Description
Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.
Arm/Group Title Non-Responders Responders
Hide Arm/Group Description:
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
Overall Number of Participants Analyzed 16 28
Mean (Standard Deviation)
Unit of Measure: Average Z-Score
-0.19  (1.76) 0.08  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Responders, Responders
Comments Mean Difference between Non-Responders and Responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments One-Sided P-Value
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 90%
-0.83 to 0.29
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All enrolled participants
 
Arm/Group Title Invasive Aspergillosis
Hide Arm/Group Description Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, and were started on standard of care antifungal therapy.
All-Cause Mortality
Invasive Aspergillosis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Invasive Aspergillosis
Affected / at Risk (%)
Total   0/116 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Invasive Aspergillosis
Affected / at Risk (%)
Total   0/116 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00854607     History of Changes
Other Study ID Numbers: 0000-089
2009_553 ( Other Identifier: Merck )
First Submitted: February 27, 2009
First Posted: March 3, 2009
Results First Submitted: July 24, 2012
Results First Posted: August 28, 2012
Last Update Posted: August 21, 2015