LeishmaniasisPhase 1/2NCT00373568
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
A Phase 1/2 study testing miltefosine: 2.5 mg/kg/day for 42 days in people with Leishmaniasis, run by AB Foundation at 1 site in Bolivia.
Trial summary
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- miltefosine: 2.5 mg/kg/day for 42 days
- How many people
- 25 participants
- Where
- 1 siteBolivia
- Study dates
- Apr 2005to Dec 2007
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mucosal leishmaniasis
Who cannot join
- No comcomitant disease as judged by laboratory and clinical parameters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Miltefosine (42 Days) for Mucosal Leishmaniasisi
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis
Read the detailed description
Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi
- Conditions
- Leishmaniasis
- Being tested
- miltefosine: 2.5 mg/kg/day for 42 days
- Keywords
- mucosal, miltefosine
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miltefosine: 2.5 mg/kg/day for 42 daysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
Secondary outcomes (1)
safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startApr 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- AB Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Jaime Soto, MD, Principal investigator, CIBIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373568
- Sponsor's protocol ID
- 05--01
- Status last verified
- May 2010
- First submitted
- 7 Sep 2006
- Last updated
- 2 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miltefosine (42 Days) for Mucosal Leishmaniasisi
- ClinicalTrials.gov ID
- NCT00373568
- Acronym / sponsor ID
- 05--01
- Conditions
- Leishmaniasis
- Keywords
- mucosal, miltefosine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- AB FoundationUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2007
- First posted
- 8 Sep 2006 (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.
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis
Detailed description
Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mucosal leishmaniasis
Key exclusion criteria (1 listed)
- No comcomitant disease as judged by laboratory and clinical parameters
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 |
|---|---|---|
| miltefosine: 2.5 mg/kg/day for 42 days | Drug | – |
Primary outcome
efficacy
1 secondary outcome
safety
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 2 Jun 2010.
Related trials for Leishmaniasis
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
Cutaneous Leishmaniasis, Pain
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
Not yet recruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Cutaneous Leishminiasis
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.
Jaime Soto, MD principal investigator
CIBIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing miltefosine: 2.5 mg/kg/day for 42 days in people with Leishmaniasis, run by AB Foundation at 1 site in Bolivia.
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 1 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: finished, as of the sponsor's last update on 2 Jun 2010. 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 Bolivia. 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.
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.
What does the primary outcome measure?
efficacy. It is what the study was designed to measure, not a finding.
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 2 Jun 2010.