Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: FDA Office of Orphan Products Development
• Treatments: Nikkomycin

Criteria

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