Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Coccidioidomycosis
In brief
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 Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.
Key facts
- Study ID
- NCT00614666
- Run by
- University of Arizona
- People needed
- 6
- Starts
- 2007-09-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2025-04-16
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical & Translational Research Center - University of Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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