N/A
N=116
An Observational Study of Fungal Biomarkers (MK-0000-089)
Aspergillosis
Bottom Line
View on ClinicalTrials.gov: NCT00854607 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: 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. — 0.20; -0.09 Average Z-Score — p=0.166
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.20; -0.09 | 0.166 |
| SECONDARY 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. |
-0.09; 0.08 | 0.269 |
| SECONDARY 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. |
0.07; -0.12 | 0.101 |
| SECONDARY 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. |
0.02; -0.00 | 0.457 |
| SECONDARY 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. |
-0.24; 0.08 | 0.168 |
| SECONDARY 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. |
0.10; -0.09 | 0.127 |
| SECONDARY 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. |
0.31; -0.16 | 0.054 |
| SECONDARY 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. |
0.25; 0.04 | 0.285 |
| SECONDARY 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. |
0.41; 0.01 | 0.159 |
| SECONDARY 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. |
0.05; -0.10 | 0.071 |
| SECONDARY 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. |
0.08; -0.10 | 0.078 |
| SECONDARY 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. |
0.27; -0.12 | 0.109 |
| SECONDARY 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. |
0.49; -0.16 | 0.030 sig |
| SECONDARY 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. |
-0.08; 0.08 | 0.293 |
| SECONDARY 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. |
-0.19; 0.08 | 0.213 |
Summary
The purpose of this study is to evaluate the relationship between fungal biomarker levels during anti-fungal therapy and the success of treatment for fungal infection. The primary hypothesis is that over the initial two weeks of anti-fungal therapy, fungal biomarkers from participants with invasive aspergillosis (IA) will be lower for those with a successful clinical outcome compared to those with a failed clinical outcome.
Eligibility Criteria
Inclusion Criteria
- Is 16 years of age or older
- Female is either post-menopausal, surgically sterilized, willing to use 2 adequate methods of birth control, or agrees to abstain from heterosexual activity throughout the study
- Female of child bearing potential must have a negative pregnancy test
- Male is surgically sterilized, agrees to use an adequate method of contraception, or agrees to abstain from heterosexual activity for the duration of the study
- Has possible, probable, or confirmed invasive aspergillosis (IA)
- Has had a computed tomography (CT) or magnetic resonance imaging (MRI) scan 72 hours prior to initiation of anti-fungal therapy
Exclusion Criteria
- Has had hemodialysis using cellulose membrane within 2 weeks of study start
Data sourced from ClinicalTrials.gov (NCT00854607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.