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Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004938
First Posted: February 25, 2000
Last Update Posted: June 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004938


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: June 9, 2006
Last Verified: April 2000

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
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors