Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
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ClinicalTrials.gov Identifier: NCT00004808 |
Recruitment Status
:
Completed
First Posted
: February 25, 2000
Last Update Posted
: June 9, 2006
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Tracking Information | ||||
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First Submitted Date ICMJE | February 24, 2000 | |||
First Posted Date ICMJE | February 25, 2000 | |||
Last Update Posted Date | June 9, 2006 | |||
Study Start Date ICMJE | September 1991 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00004808 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis | |||
Official Title ICMJE | Not Provided | |||
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. |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: fluconazole | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
78 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Patient Characteristics--
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Sex/Gender |
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Ages | 12 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00004808 | |||
Other Study ID Numbers ICMJE | 199/12010 NIAID-MSG-13 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | National Center for Research Resources (NCRR) | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Office of Rare Diseases (ORD) | |||
Verification Date | December 2001 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |