Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
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.
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 antifungal therapy for uncomplicated disease are not currently established.
 Current therapies for serious and complicated forms of coccidioidomycosis are only partially
 effective and in themselves are unable to eradicate the fungus from sites of infection,
 commonly resulting in breakthrough infection and/or relapse. Nikkomycin Z is effective in the
 mouse model and results in improved microbiological response over fluconazole.

 The goals of this study include: 1) Evaluating the safety and tolerance of nikkomycin Z
 following administration of multiple doses (50 mg Q 12 h to 750 mg Q 8 h) for two week and 2)
 Evaluating the pharmacokinetics of nikkomycin Z after single and multiple doses in
 relationship to dose. The study will include patients with uncomplicated Coccidioides
 pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response
 based on biomarkers.
Inclusion Criteria:

 -  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 Criteria:

 -  Patients under the age of 18 years or over 50 years

 -  Patients with a 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