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
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: 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 July 28, 2014