Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004811
Status:
COMPLETED
Last Update Posted:
2006-06-09
First Post:
2000-02-24
Brief Title:
Phase III Study of Itraconazole for Blastomycosis Histoplasmosis 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 Evaluate the tolerance of patients with blastomycosis histoplasmosis and sporotrichosis to different doses of itraconazole R51211
II Determine levels of itraconazole in serum and other body fluids III Assess the course of illness during itraconazole therapy IV Determine the dosage of itraconazole that is safe and well tolerated by 80-90 of patients and estimate the potential of this dosage for use in future comparative trials
II Determine levels of itraconazole in serum and other body fluids III Assess the course of illness during itraconazole therapy IV Determine the dosage of itraconazole that is safe and well tolerated by 80-90 of patients and estimate the potential of this dosage for use in future comparative trials
Detailed Description:
PROTOCOL OUTLINE This is a study to estimate the optimal dose of oral itraconazole Patients are treated at 1 of 3 doses of itraconazole the starting dose for each patient is determined at entry
Therapy is administered daily for 3-6 months Patients with progressive disease may be treated at the next higher dose there may be only 1 such increase Concurrent systemic and topical antifungals are prohibited
Patients are followed at 1 3 6 and 12 months
Therapy is administered daily for 3-6 months Patients with progressive disease may be treated at the next higher dose there may be only 1 such increase Concurrent systemic and topical antifungals are prohibited
Patients are followed at 1 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-6A | None | None | None |