Leishmaniasis, CutaneousPhase 2NCT03445897
Miltefosine Plus IL Pentamidine for Bolivian CL
A Phase 2 study testing miltefosine plus intralesional pentamidine in people with Leishmaniasis, Cutaneous, run by Jonathan Berman.
Trial summary
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- miltefosine plus intralesional pentamidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2016to 21 Feb 2018
- 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
Who may be able to join
- one ulcerative lesion ≤ 900 mm2 in total area,
- ≥ 12 years,
- parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
- no antileishmanial therapy in the last 3 months,
- no mucosal lesions,
- no history of significant concomitant diseases including immunosuppression.
Who cannot join
None listed.
About this study
Official title: Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Read the detailed description
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- miltefosine plus intralesional pentamidine
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miltefosine plus intralesional pentamidineDrug
miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Receives: Drug: miltefosine plus intralesional pentamidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion size
area of lesion
Measured: 6 months post therapy
Secondary outcomes (2)
adverse effects at site
pain, erythema, edema
Measured: days 1, 3, 5 of therapy
systemic adverse effects
gastrointestinal side effects
Measured: days 1 to 28 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start31 Jan 2016
- Primary completion31 Jan 2018
- Study completion21 Feb 2018
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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Berman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Berman, AB Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445897
- Sponsor's protocol ID
- ABF MP
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia
- ClinicalTrials.gov ID
- NCT03445897
- Acronym / sponsor ID
- ABF MP
- Conditions
- Leishmaniasis, Cutaneous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jonathan BermanUniversity, hospital or other
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- 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.
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Detailed description
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: miltefosine plus intralesional pentamidinemiltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- one ulcerative lesion ≤ 900 mm2 in total area,
- ≥ 12 years,
- parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
- no antileishmanial therapy in the last 3 months,
- no mucosal lesions,
Key exclusion criteria (0 listed)
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 plus intralesional pentamidinemiltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). | Drug | Intervention |
Primary outcome
Lesion size
Time frame: 6 months post therapy
area of lesion
2 secondary outcomes
adverse effects at site
Time frame: days 1, 3, 5 of therapy
systemic adverse effects
Time frame: days 1 to 28 of therapy
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 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing miltefosine plus intralesional pentamidine in people with Leishmaniasis, Cutaneous, run by Jonathan Berman.
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 6 inclusion and 0 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 27 Feb 2018. 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.
What does the primary outcome measure?
Lesion size (time frame: 6 months post therapy). 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 27 Feb 2018.