Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00854607
Other study ID # 0000-089
Secondary ID 2009_553
Status Completed
Phase N/A
First received February 27, 2009
Last updated August 4, 2015
Start date March 2009
Est. completion date August 2011

Study information

Verified date August 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No Intervention
Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Neofytos D, Railkar R, Mullane KM, Fredricks DN, Granwehr B, Marr KA, Almyroudis NG, Kontoyiannis DP, Maertens J, Fox R, Douglas C, Iannone R, Kauh E, Shire N. Correlation between Circulating Fungal Biomarkers and Clinical Outcome in Invasive Aspergillosi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-ß-D-glucan (ßDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and ßDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and ßDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and ßDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and ßDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and ßDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of %CFB of Fungal Biomarkers GM and ßDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Weeks 1 and 2 No
Secondary Average of the Z-scores of the TWA of Fungal Biomarkers GM and ßDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Week 1 No
Secondary Average of the Z-scores of the TWA of Fungal Biomarkers GM and ßDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Week 1 No
Secondary Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and ßDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Week 1 No
Secondary Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and ßDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Week 1 No
Secondary Average of the Z-scores of the TWA of Fungal Biomarkers GM and ßDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Weeks 1 through 6 No
Secondary Average of the Z-scores of the TWA of Fungal Biomarkers GM and ßDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Weeks 1 through 6 No
Secondary Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and ßDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6. 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 ßDG. 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. Weeks 1 through 6 No
Secondary Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and ßDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12. 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 ßDG. 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. Weeks 1 through 6 No
See also
  Status Clinical Trial Phase
Suspended NCT01887457 - Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy Phase 2
Completed NCT00940017 - A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects Phase 4
Enrolling by invitation NCT01617759 - Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis
Terminated NCT03905447 - The Effect of Early Treatment of PC945 on Aspergillus Fumigatus Lung Infection in Lung Transplant Patients. Phase 2
Recruiting NCT04744454 - Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
Completed NCT02715570 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of PC945 Phase 1
Withdrawn NCT01622595 - UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients N/A
Completed NCT00001937 - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients Phase 3
Completed NCT04935463 - Mucormycosis in COVID-19
Withdrawn NCT01188759 - Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects Phase 3
Completed NCT00473252 - Surveillance of Fungal Infections During Construction Activity N/A
Completed NCT00037206 - A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA). Phase 2/Phase 3
Completed NCT04818853 - COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
Completed NCT00412893 - Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis Phase 3
Recruiting NCT06135597 - Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection
Terminated NCT02646800 - Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp Phase 4
Completed NCT00388167 - Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection Phase 4
Completed NCT05065658 - Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
Completed NCT00005912 - Voriconazole to Prevent Systemic Fungal Infections in Children Phase 1
Completed NCT04431804 - THYME AND CARVACROLL Nanoparticle Effect on Fungi