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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aspergillosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Invasive Aspergillosis

Observational

No Intervention

Intervention Type OTHER

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

Interventions

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No Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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