An Observational Study of Fungal Biomarkers (0000-089 AM3)

This study has been completed.

First Received on February 27, 2009. Last Updated on January 20, 2012 History of Changes

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00854607

Purpose

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

Condition	Intervention
Aspergillosis	Other: No Intervention

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective, Non-Intervention, Observational Assessment of the Correlation Between Circulating Biomarkers of Fungal Bioburden and Clinical Outcome in the Setting of Invasive Aspergillosis

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis Molds

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Relationship between biomarker levels and success of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Biospecimen Description:

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

Enrollment:	114
Study Start Date:	May 2009
Study Completion Date:	August 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Observational	Other: No Intervention Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Participants will be selected through collaborations with clinicians.

Criteria

Inclusion Criteria:

Patient is 16 or older
Female patient 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 patients of child bearing potential must have a negative pregnancy test
Male patient is surgically sterilized, agrees to use an adequate method of contraception, or agrees to abstain from heterosexual activity for the duration of the study
Patient has possible, probable, or confirmed invasive aspergillosis
patient has had a CT or MRI 72 hours prior to initiation of anti-fungal therapy

Exclusion Criteria:

Patient has had hemodialysis using cellulose membrane within 2 weeks of study start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854607

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00854607 History of Changes
Other Study ID Numbers:	2009_553, MK-0000-089
Study First Received:	February 27, 2009
Last Updated:	January 20, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Aspergillosis
Mycoses

ClinicalTrials.gov processed this record on February 09, 2012