Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004808
Status:
COMPLETED
Last Update Posted:
2006-06-09
First Post:
2000-02-24
Brief Title:
Phase II Pilot Study of Fluconazole for Histoplasmosis Blastomycosis and Sporotrichosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Identify a preferred oral fluconazole dose regimen for patients with non-acute histoplasmosis or blastomycosis or ulcerocutaneous or deep sporotrichosis
II Study the safety and efficacy of fluconazole in these patients
II Study the safety and efficacy of fluconazole in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are stratified by participating institution and type of infection
Patients with blastomycosis are randomly assigned to moderate- versus high-dose oral fluconazole Based on clinical response the dose is increased at 1 and 2 months for patients in the moderate-dose group Patients in the high-dose group receive a fixed dose of fluconazole
Patients with histoplasmosis and sporotrichosis are nonrandomly treated with moderate-dose fluconazole
Therapy is administered daily for 3 months beyond stabilization of infection maximum 24 months or for a total of 6 months if the infection stabilizes within 3 months Fluconazole may be administered intravenously maximum 7 days if the oral dose is not tolerated
Concurrent systemic or intrathecal antifungals immunostimulants and lymphocyte replacement are prohibited Investigational agents or approved agents given for investigational indications are also not permitted on study
Patients are followed at 3 6 and 12 months
Patients with blastomycosis are randomly assigned to moderate- versus high-dose oral fluconazole Based on clinical response the dose is increased at 1 and 2 months for patients in the moderate-dose group Patients in the high-dose group receive a fixed dose of fluconazole
Patients with histoplasmosis and sporotrichosis are nonrandomly treated with moderate-dose fluconazole
Therapy is administered daily for 3 months beyond stabilization of infection maximum 24 months or for a total of 6 months if the infection stabilizes within 3 months Fluconazole may be administered intravenously maximum 7 days if the oral dose is not tolerated
Concurrent systemic or intrathecal antifungals immunostimulants and lymphocyte replacement are prohibited Investigational agents or approved agents given for investigational indications are also not permitted on study
Patients are followed at 3 6 and 12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID-MSG-13 | None | None | None |