HistoplasmosisPhase 1/2NCT00004811
Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
A Phase 1/2 study testing itraconazole in people with Histoplasmosis and Sporotrichosis, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211). II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histoplasmosis, Sporotrichosis, Blastomycosis
- What is being tested?
- itraconazole
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Mar 1985to not given
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Culture-proven fungal disease, i.e.: Chronic cavitary histoplasmosis Extrapulmonary histoplasmosis, e.g., mucosal disease Blastomycosis Sporotrichosis Positive culture after last dose of any prior therapy Requires antifungal therapy with amphotericin B or ketoconazole No fungal meningitis No central nervous system disease No immediately life-threatening disease --Prior/Concurrent Therapy-- At least 1 month since therapy for same disease No more than 2 mg/kg prior amphotericin B (total dose) No more than 2 mg/kg prior ketoconazole (total dose) No concurrent immunosuppressives, including: Corticosteroids Azathioprine Cytotoxic agents --Patient Characteristics-- Hepatic: AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Bilirubin no greater than 3 mg/dL Other: No acquired immunodeficiency syndrome No pregnant or nursing women Effective contraception required of fertile women
About this study
OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211).
II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.
Read the detailed description
PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry.
Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited.
Patients are followed at 1, 3, 6, and 12 months.
- Conditions
- Histoplasmosis, Sporotrichosis, Blastomycosis
- Being tested
- itraconazole
- 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.
itraconazoleDrug
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 startMar 1985
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 1/2
- Primary purpose
- Treatment
- Enrolment
- 7 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
- NCT00004811
- Sponsor's protocol ID
- 199/12013
- Other IDs
- NIAID-MSG-6A
- 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 I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
- ClinicalTrials.gov ID
- NCT00004811
- Acronym / sponsor ID
- 199/12013
- Conditions
- Histoplasmosis, Sporotrichosis, Blastomycosis
- Keywords
- blastomycosis, fungal infection, histoplasmosis, immunologic disorders and infectious disorders, rare disease, sporotrichosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 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
- Mar 1985
- 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. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211).
II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.
Detailed description
PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry.
Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited.
Patients are followed at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| itraconazole | 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 1/2 study testing itraconazole 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.