Status:
TERMINATED
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Coccidioidomycosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin...
Detailed Description
Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority of these illnesses occur as a result of endemic exposure in Arizona and California. The benefits of antifu...
Eligibility Criteria
Inclusion
- Age \>= 18 years and \<= 50 years
- Male or Female (if female, must have a negative pregnancy test and agree to use an acceptable contraception method)
- Able to understand study and give written informed consent
- Have a respiratory illness with at least one of the following: Cough, chest pain dyspnea or tachypnea, sputum production, or fever/chills/night sweats
- Have a new or suspected new pulmonary infiltrate on Chest X-ray
- Have a positive coccidioidal serology by EIA or immunodiffusion
Exclusion
- Patients under the age of 18 years or over 50 years
- Patients with a prior history of confirmed coccidioidal infection
- Laboratory diagnosis of another etiology for the inclusion-defining illness
- Inability to comprehend study and provide informed consent
- History of or current evidence of major organ disease
- Concomitant use of prednisone and other corticosteroids not permitted
- Concomitant immunosuppressive therapy is not permitted
- Concomitant antibacterial therapy is not permitted
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00614666
Start Date
September 1 2007
End Date
September 1 2009
Last Update
April 16 2025
Active Locations (1)
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1
Clinical & Translational Research Center - University of Arizona
Tucson, Arizona, United States, 85721