ClinicalTrials.gg
CompletedNCT00004938Updated Jun 9, 2006

Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

A Phase 2 interventional study of fluconazole in Sporotrichosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2006-06-09.

Primary conditionMycoses(the registry's first term)UnverifiedIs this wrong?The registry often attaches Mycoses to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

OBJECTIVE:

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

Read the detailed description

PROTOCOL OUTLINE:

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

02

Conditions studied

  • Sporotrichosis

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Keywords

  • fungal infection
  • rare disease
  • sporotrichosis
03

In context

Mycoses Unverified

260 studies on the registry are indexed under Mycoses; 37 are open to participants now.

This study's enrollment of 30 is below the median of 68 across 164 interventional studies indexed under Mycoses.

Browse Mycoses studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Compared within Mycoses, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 infection No pregnant or nursing women

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Enrollment
30 participants

Interventions

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Kauffman CA, Pappas PG, McKinsey DS, Greenfield RA, Perfect JR, Cloud GA, Thomas CJ, Dismukes WE. Treatment of lymphocutaneous and visceral sporotrichosis with fluconazole. Clin Infect Dis. 1996 Jan;22(1):46-50. doi: 10.1093/clinids/22.1.46. PubMed 8824965 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 1996 and a completion of Aug 1996. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2000
First posted
Feb 25, 2000
Start
Aug 1996
Completion
Aug 1996
Last update
Jun 9, 2006
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jun 9, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004938
First posted
Feb 25, 2000
Start date
Aug 1996
Completion
Aug 1996
Last update
Jun 9, 2006

Study contacts

William Dismukes
study chair · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2000. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fluconazole

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