Leishmaniasis; BrazilianPhase 2/3NCT06040489
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
A Phase 2/3 study testing Miltefosine 50mg, Pentoxifylline 400mg and Liposomal Amphotericin B in people with Leishmaniasis; Brazilian and Leishmaniasis, Mucocutaneous, run by University of Brasilia at 1 site in Brazil.
Trial summary
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous
- What is being tested?
- Miltefosine 50mg, Pentoxifylline 400mg and Liposomal Amphotericin B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jun 2022to Jun 2026
- Phase
- Phase 2/3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
- Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
- Agree and sing informed consent form
Who cannot join
- Previous treatment with leishmanicidal drugs in the last 6 months
- Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
- Serum creatinine or urea 1.5 times the upper limit of normal
- Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
- history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline
- Pregnant and breastfeeding women
- Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitario de Brasilia
Brasília, Federal District, 70840-901
Raimunda Sampaio, PhD, +556120285415, rnrsampaio@hotmail.com
About this study
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
- Being tested
- Miltefosine 50mg, Pentoxifylline 400mg, Liposomal Amphotericin B
- Keywords
- Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment
- Medical subject headings
- Leishmaniasis, Leishmaniasis, Mucocutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miltefosine 50mgDrug
Oral Miltefosine 50mg bid
Pentoxifylline 400mgDrug
Oral Pentoxifylline 400mg tid
Liposomal Amphotericin BDrug
Intravenous 25 to 40mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis | Experimental | Not described Receives: Drug: Miltefosine 50mg; Drug: Pentoxifylline 400mg |
| Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis | Experimental | Not described Receives: Drug: Miltefosine 50mg; Drug: Pentoxifylline 400mg |
| Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis | Active comparator | Not described Receives: Drug: Liposomal Amphotericin B |
| Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis | Active comparator | Not described Receives: Drug: Liposomal Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
Measured: 90 days after the begin of treatment
Secondary outcomes (1)
Adverse effects
Presence laboratorial or clinica changes during treatment that lead to treatment interruption
Measured: 30 days after drug interruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start22 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis; BrazilianStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040489
- Sponsor's protocol ID
- 57768421.0.0000.5558
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
- ClinicalTrials.gov ID
- NCT06040489
- Acronym / sponsor ID
- 57768421.0.0000.5558
- Keywords
- Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Sep 2023 (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.
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis | Experimental | Drug: Miltefosine 50mg, Drug: Pentoxifylline 400mg |
| Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis | Experimental | Drug: Miltefosine 50mg, Drug: Pentoxifylline 400mg |
| Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis | Active comparator | Drug: Liposomal Amphotericin B |
| Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis | Active comparator | Drug: Liposomal Amphotericin B |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
- Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
- Agree and sing informed consent form
Key exclusion criteria (7 listed)
- Previous treatment with leishmanicidal drugs in the last 6 months
- Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
- Serum creatinine or urea 1.5 times the upper limit of normal
- Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
- history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline
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 50mgOral Miltefosine 50mg bid | Drug | Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis, Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis |
| Pentoxifylline 400mgOral Pentoxifylline 400mg tid | Drug | Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis, Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis |
| Liposomal Amphotericin BIntravenous 25 to 40mg/kg | Drug | Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis, Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis |
Primary outcome
Cure
Time frame: 90 days after the begin of treatment
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
1 secondary outcome
Adverse effects
Time frame: 30 days after drug interruption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Miltefosine 50mg, Pentoxifylline 400mg and Liposomal Amphotericin B in people with Leishmaniasis; Brazilian and Leishmaniasis, Mucocutaneous, 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 3 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 15 Sep 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Raimunda Sampaio, PhD (+556120285415, rnrsampaio@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure (time frame: 90 days after the begin of treatment). 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 15 Sep 2023.