Overview

Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center for Research Resources (NCRR)
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Alabama at Birmingham
Treatments:
Fluconazole
Criteria
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 5 times normal Alkaline phosphatase no greater
than 5 times normal Bilirubin no greater than 5 times normal PT no greater than 5
seconds above normal or control and not corrected with vitamin K

- Other: No HIV infection No AIDS (Centers for Disease Control and Prevention criteria)
No requirement for any of the following: Barbiturates Phenytoin Oral hypoglycemics
Coumarin-type anticoagulants No pregnant or nursing women Negative pregnancy test
required of fertile women Effective contraception required of fertile women