LeishmaniasisPhase 2NCT02530697
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
A Phase 2 study testing Meglumine antimoniate, Miltefosine and Pentoxifylline in people with Leishmaniasis, run by University of Brasilia at 1 site in Brazil.
Trial summary
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- Meglumine antimoniate, Miltefosine and Pentoxifylline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Aug 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
- For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
- Ages between 18 and 80 years old;
- Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
- Agree to participate in the study and sign the informed consent term.
Who cannot join
- Use of any leishmanicidal drugs six months prior;
- Clinical or laboratorial evidences of electrocardiographic disorders;
- Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
- Hypersensitivity to meglucamine antimoniate;
- Pregnancy or lactation;
- Fertile females that do not agree to use contraceptive methods;
- Patients that do not agree to the informed consent term.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário de Brasília
Brasília, Federal District, 70.840-901
About this study
Official title: The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
- Conditions
- Leishmaniasis
- Being tested
- Meglumine antimoniate, Miltefosine, Pentoxifylline
- Keywords
- Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meglumine antimoniateDrug
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
MiltefosineDrug
Also called Miltefosnine
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
PentoxifyllineDrug
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Mucosal Antimoniate and Pentoxifylline | Active comparator | 20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days. Receives: Drug: Meglumine antimoniate; Drug: Pentoxifylline |
| Group 2 - Mucosal Miltefosine and Pentoxifylline | Experimental | Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days. Receives: Drug: Miltefosine; Drug: Pentoxifylline |
| Group 3 - Cutaneous Antimoniate and Pentoxifylline | Experimental | 20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days. Receives: Drug: Meglumine antimoniate; Drug: Pentoxifylline |
| Group 4 - Cutaneous Miltefosine and Pentoxifylline | Experimental | Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days. Receives: Drug: Miltefosine; Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure
Complete healing of previous lesions until the 90th day after the begin of the treatment
Measured: 90 days
Failure
Lesions fail to heal until the 90th day after the begin of the treatment
Measured: 90 days
Relapse
Lesions that reappear on the scar of a previously healed lesion
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SOFIA SALES MARTINS, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530697
- Sponsor's protocol ID
- 40068714.1.0000.5558
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2015
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
- ClinicalTrials.gov ID
- NCT02530697
- Acronym / sponsor ID
- 40068714.1.0000.5558
- Conditions
- Leishmaniasis
- Keywords
- Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Aug 2015 (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.
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Mucosal Antimoniate and Pentoxifylline | Active comparator | Drug: Meglumine antimoniate, Drug: Pentoxifylline20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days. |
| Group 2 - Mucosal Miltefosine and Pentoxifylline | Experimental | Drug: Miltefosine, Drug: PentoxifyllineOral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days. |
| Group 3 - Cutaneous Antimoniate and Pentoxifylline | Experimental | Drug: Meglumine antimoniate, Drug: Pentoxifylline20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days. |
| Group 4 - Cutaneous Miltefosine and Pentoxifylline | Experimental | Drug: Miltefosine, Drug: PentoxifyllineOral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
- For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
- Ages between 18 and 80 years old;
- Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
- Agree to participate in the study and sign the informed consent term.
Key exclusion criteria (7 listed)
- Use of any leishmanicidal drugs six months prior;
- Clinical or laboratorial evidences of electrocardiographic disorders;
- Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
- Hypersensitivity to meglucamine antimoniate;
- Pregnancy or lactation;
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 |
|---|---|---|
| Meglumine antimoniate20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. | Drug | Group 1 - Mucosal Antimoniate and Pentoxifylline, Group 3 - Cutaneous Antimoniate and Pentoxifylline |
| MiltefosineAlso: MiltefosnineMiltefosine 2,5mg/kg/day up to 50mg 2x/daily. | Drug | Group 2 - Mucosal Miltefosine and Pentoxifylline, Group 4 - Cutaneous Miltefosine and Pentoxifylline |
| PentoxifyllinePentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days. | Drug | Group 1 - Mucosal Antimoniate and Pentoxifylline, Group 2 - Mucosal Miltefosine and Pentoxifylline, Group 3 - Cutaneous Antimoniate and Pentoxifylline, Group 4 - Cutaneous Miltefosine and Pentoxifylline |
Primary outcome
Cure
Time frame: 90 days
Complete healing of previous lesions until the 90th day after the begin of the treatment
Failure
Time frame: 90 days
Lesions fail to heal until the 90th day after the begin of the treatment
Relapse
Time frame: 90 days
Lesions that reappear on the scar of a previously healed lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meglumine antimoniate, Miltefosine and Pentoxifylline in people with Leishmaniasis, run by University of Brasilia at 1 site in Brazil.
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 5 inclusion and 7 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 16 Jan 2024. 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 Brazil. 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 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?
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.
What does the primary outcome measure?
Cure (time frame: 90 days). The study lists 3 primary outcomes in all. 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 16 Jan 2024.