Overview
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Status:
Terminated
Terminated
Trial end date:
2009-09-01
2009-09-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of ArizonaCollaborator:
FDA Office of Orphan Products DevelopmentTreatments:
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