Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis (NCT00004808) | Clinical Trial Compass
CompletedPhase 2
Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
78 participantsStarted 1991-09
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Clinical, radiographic, nuclear medicine, or similar study findings compatible with active infection with any of the following: Histoplasma capsulatum Blastomyces dermatiditis Sporothrix schenckii
* At least 1 positive culture within 8 weeks prior to entry Diagnostic histopathology fulfills requirement if confirmed by second independent reviewer
* Sporotrichosis, i.e.: Ulcerocutaneous disease limited to local or regional skin and lymphatics OR Deep infection of tissue or sites other than locoregional skin/lymphatics
* Histoplasmosis and blastomycosis with acute pulmonary infection as sole site of disease eligible only if progressive, i.e.: Clinically or radiographically apparent new lesions or continued increase in old lesions for more than 20 days after acute illness onset Positive culture or histopathology at least 20 days after illness onset
* Relapsed disease eligible, as follows: Clinical evidence of active disease Positive culture within 8 weeks prior to entry Histopathologic evidence alone not acceptable for entry No more than 3 days of systemic amphotericin B or ketoconazole since positive culture
* Infection site present at study entry, i.e., no prior surgical removal
* No active meningeal or central nervous system infection Diagnostic tests required if symptomatic
* No immediately life-threatening infection
--Patient Characteristics--
* Life expectancy: At least 1 week
* Hepatic: AST and ALT no greater than …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00004808
SponsorNational Center for Research Resources (NCRR)