Leishmaniasis, CutaneousNCT00508963
Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
A study testing sodium stibogluconate (Pentostam) in people with Leishmaniasis, Cutaneous and Leishmaniasis, Mucocutaneous, run by University of California, San Francisco at 1 site in United States.
Trial summary
Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous
- What is being tested?
- sodium stibogluconate (Pentostam)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Biopsy proven new world cutaneous or mucocutaneous leishmania
Who cannot join
- Prolonged QT
- Liver disease
- Pancreatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of CA at San Francisco Hospitals and Clinics
San Francisco, California, 94143
About this study
Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).
- Being tested
- sodium stibogluconate (Pentostam)
- Keywords
- New World Cutaneous or Mucocutaneous Leishmaniasis
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium stibogluconate (Pentostam)Drug
20 mg/kg IV every day for 20 or 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Schwartz, MD, Principal investigator, University of CA at San FranciscoKanade Shinkai, MD, Principal investigator, University of CA at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508963
- Sponsor's protocol ID
- UCSF Infectious Diseases
- Status last verified
- May 2023
- First submitted
- 27 Jul 2007
- Last updated
- 27 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
- ClinicalTrials.gov ID
- NCT00508963
- Acronym / sponsor ID
- UCSF Infectious Diseases
- Keywords
- New World Cutaneous or Mucocutaneous Leishmaniasis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- First posted
- 30 Jul 2007 (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.
Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy proven new world cutaneous or mucocutaneous leishmania
Key exclusion criteria (3 listed)
- Prolonged QT
- Liver disease
- Pancreatitis
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 |
|---|---|---|
| sodium stibogluconate (Pentostam)20 mg/kg IV every day for 20 or 28 days | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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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.
Brian Schwartz, MD principal investigator
University of CA at San Francisco
Kanade Shinkai, MD principal investigator
University of CA at San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium stibogluconate (Pentostam) in people with Leishmaniasis, Cutaneous and Leishmaniasis, Mucocutaneous, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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 27 Dec 2023.