Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004938
First received: February 24, 2000
Last updated: June 8, 2006
Last verified: April 2000
  Purpose

OBJECTIVE:

I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.


Condition Intervention Phase
Sporotrichosis
Drug: fluconazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:


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

Estimated Enrollment: 30
Study Start Date: August 1996
Estimated Study Completion Date: August 1996
Detailed Description:

PROTOCOL OUTLINE:

Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Presumptive evidence of sporotrichosis Culture-proven sporotrichosis determined on study Relapsing disease following antifungal therapy eligible if culture positive for Sporothrix schenckii prior to entry No life-threatening disease No central nervous system sporotrichosis --Prior/Concurrent Therapy-- No concurrent drugs known to react with fluconazole No more than 3 days of systemic antifungals for current sporotrichosis episode --Patient Characteristics-- Hepatic: Liver function tests no greater than 5 times normal Other: No HIV infection No pregnant or nursing women

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004938

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

Publications:
ClinicalTrials.gov Identifier: NCT00004938     History of Changes
Other Study ID Numbers: 199/11815, NIAID-MSG-11815
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):
fungal infection
rare disease
sporotrichosis

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

ClinicalTrials.gov processed this record on April 17, 2014