Clinical Trial: Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase I/II Evaluation of the Safety, Pharmacokinetics, and Preliminary Effectiveness of Nikkomycin Z in the Treatment of Patients With Uncomplicated Coccidioides Pneumonia
Brief 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.
Detailed Summary:
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.
Sponsor: University of Arizona
Current Primary Outcome: Determine safety and tolerance of nikkomycin Z in relatively healthy subjects following administration of multiple doses. [ Time Frame: four weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Evaluate the multiple dose pharmacokinetics of nikkomycin Z in patients with uncomplicated coccidioidal pneumonia [ Time Frame: 2 weeks ]
Original Secondary Outcome: Same as current
Information By: University of Arizona
Dates:
Date Received: January 31, 2008
Date Started: September 2007
Date Completion:
Last Updated: February 12, 2013
Last Verified: August 2009
