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

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004808
First received: February 24, 2000
Last updated: June 8, 2006
Last verified: December 2001
  Purpose

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.


Condition Intervention Phase
Histoplasmosis
Sporotrichosis
Blastomycosis
Drug: fluconazole
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 78
Study Start Date: September 1991
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004808

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: William Dismukes University of Alabama at Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004808     History of Changes
Other Study ID Numbers: 199/12010, NIAID-MSG-13
Study First Received: February 24, 2000
Last Updated: June 8, 2006
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
blastomycosis
fungal infection
histoplasmosis
immunologic disorders and infectious disorders
rare disease
sporotrichosis

Additional relevant MeSH terms:
Blastomycosis
Histoplasmosis
Sporotrichosis
Dermatomycoses
Infection
Mycoses
Skin Diseases
Skin Diseases, Infectious
Fluconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014