HistoplasmosisPhase 2NCT00004808
Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
A Phase 2 study testing fluconazole in people with Histoplasmosis and Sporotrichosis, run by National Center for Research Resources (NCRR).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Histoplasmosis, Sporotrichosis, Blastomycosis
- What is being tested?
- fluconazole
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Sep 1991to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
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.
Read the 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.
- Conditions
- Histoplasmosis, Sporotrichosis, Blastomycosis
- Being tested
- fluconazole
- Keywords
- blastomycosis, fungal infection, histoplasmosis, immunologic disorders and infectious disorders, rare disease, sporotrichosis
- Medical subject headings
- Histoplasmosis, Sporotrichosis, Blastomycosis, Mycoses, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startSep 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistoplasmosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 78 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Alabama at Birmingham
- Investigators
- William Dismukes, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004808
- Sponsor's protocol ID
- 199/12010
- Other IDs
- NIAID-MSG-13
- Status last verified
- Dec 2001
- First submitted
- 24 Feb 2000
- Last updated
- 9 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
- ClinicalTrials.gov ID
- NCT00004808
- Acronym / sponsor ID
- 199/12010
- Conditions
- Histoplasmosis, Sporotrichosis, Blastomycosis
- Keywords
- blastomycosis, fungal infection, histoplasmosis, immunologic disorders and infectious disorders, rare disease, sporotrichosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Alabama at Birmingham
- Study start
- Sep 1991
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluconazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Dismukes study chair
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluconazole in people with Histoplasmosis and Sporotrichosis, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2006.