Overview

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