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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Aspergillosis

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00854607

0000-089

2009_553 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

116 participants in 1 patient group

Invasive Aspergillosis

Description:

Observational

Treatment:

Other: No Intervention