Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine how safe, effective, and well tolerated a new investigational antifungal drug, SUBA-itraconazole, is for patients who have been previously treated with fluconazole and have had either an insufficient response to treatment with fluconazole or a negative reaction to fluconazole preventing their further treatment with it.


Clinical Trial Description

This is a prospective, multi-center, open-label study involving subjects with proven or probable coccidioidomycosis refractory to fluconazole therapy following >40 days of treatment or subjects with proven or probable coccidioidomycosis who are intolerant to fluconazole. The availability "Super Bioavailability" (SUBA) itraconazole 65 mg capsules with twice-daily dosing options with improved pharmacokinetics and lack of food or acidity requirements offers a substantial opportunity to improve the treatment of subjects with coccidioidomycosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04809649
Study type Interventional
Source University of California, Davis
Contact
Status Withdrawn
Phase Phase 2
Start date May 15, 2021
Completion date September 2022

See also
  Status Clinical Trial Phase
Completed NCT04208321 - Safety and Pharmacokinetics of VT-1598 Phase 1
Terminated NCT00614666 - Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment Phase 1/Phase 2
Recruiting NCT02190266 - Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
Completed NCT00796809 - Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis N/A
Withdrawn NCT02908334 - Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis Phase 2
Completed NCT00423267 - POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED) Phase 3
Completed NCT00690092 - A Multi-center Study of Spherule-Derived Coccidioidin Phase 3
Completed NCT03908632 - An Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis in Persons Aged > / = 14 Years Presenting With Community Acquired Pneumonia (CAP) in Endemic Areas (SAnds-PPC)
Terminated NCT02663674 - Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever) Phase 4
Terminated NCT03618992 - Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment N/A
Completed NCT03059992 - Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment Phase 3
Completed NCT00002325 - A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common N/A