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

NCT00854607 | Completed Results

• 2 other identifiers: 0000-0892009_553
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Weeks 1 and 2

Secondary Outcomes (14)

• 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.

  Weeks 1 and 2

• 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.

  Weeks 1 and 2

• 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.

  Weeks 1 and 2

• 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.

  Weeks 1 and 2

• 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.

  Weeks 1 and 2

Study Arms (1)

Invasive Aspergillosis

Observational

Other: No Intervention

Interventions

No Intervention OTHER

Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.

Invasive Aspergillosis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected through collaborations with clinicians.

You may qualify if:

• 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

You may not qualify if:

• Has had hemodialysis using cellulose membrane within 2 weeks of study start

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 Aspergillosis. PLoS One. 2015 Jun 24;10(6):e0129022. doi: 10.1371/journal.pone.0129022. eCollection 2015.

  PMID: 26107507 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected for 12 weeks to evaluate levels of fungal biomarkers.

MeSH Terms

Conditions

Aspergillosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 3, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 21, 2015
• Results First Posted: August 28, 2012

Record last verified: 2015-08