Mucosal LeishmaniasisPhase 3NCT04799236
Treatment of Mucosal Bolivian Leishmaniasis
A Phase 3 study testing Group 1: Miltefosine, Group 2: Pentavalent Antimony and Group 3: Liposomal amphotericin B in people with Mucosal Leishmaniasis, run by Fundacion Nacional de Dermatologia at 1 site in Bolivia.
Trial summary
The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Mucosal Leishmaniasis
- What is being tested?
- Group 1: Miltefosine, Group 2: Pentavalent Antimony and Group 3: 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
- 120 participants
- Where
- 1 siteBolivia
- Study dates
- 1 Apr 2021to 30 Nov 2024
- Phase
- Phase 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- weight over 45 kg
- Parasitological confirmation of the lesion will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion.
Who cannot join
- Previous treatment for leishmaniasis in the last 12 months
- concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment
- values of complete blood count, liver function (aspartate aminotransferase, alkaline phosphatase), renal function (creatinine), pancreatic function (lipase), or uric acid beyond 1.5 x normal range
- EKG with clinically significant abnormalities
- Women of childbearing age not agreeing with the use of secure reproductive contraception for 4 months after initiating miltefosine therapy.
Trial locations and contacts
1 site in 1 country.
Bolivia1 site, 1 recruiting
- Recruiting
Hospital Dermatologico de Jorochito
Santa Cruz de la Sierra, SC, 00000
jaime soto, MD, 75648894, jasm.dlb@gmail.com
Patricia Gutierrez, Lic, 67842725, pgutierrezduenas@gmail.com
About this study
Official title: Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B
The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral >>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.
- Conditions
- Mucosal Leishmaniasis
- Being tested
- Group 1: Miltefosine, Group 2: Pentavalent Antimony, Group 3: Liposomal amphotericin B
- Medical subject headings
- Leishmaniasis, Mucocutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: MiltefosineDrug
Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
Group 2: Pentavalent AntimonyDrug
will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
Group 3: Liposomal amphotericin BDrug
3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Oral Miltefosine | Active comparator | Miltefosine will be administered per os at 150 mg/day [50 mg tid] for 28 days. This is the standard regimen of miltefosine for persons >45 kg. Receives: Drug: Group 1: Miltefosine |
| Group 2: Intravenous pentavalent antimony | Active comparator | IV pentavalent antimony (meglumine antimoniate) will be administrated at 20 mg x kg x d during 20 consecutive days. Antimony will be diluted in 10 times its volume in 5%Dextrose in destilled water and injected IV in 20 minutes Receives: Drug: Group 2: Pentavalent Antimony |
| Group 3: Intravenous liposomal amphotericin B | Experimental | LAMB will be administered IV at 3 ampules [150 mg] on each of days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Three ampules is the individual dose suggested by Aronson et al [2016] and equals 2.5 mg/kg/dose for a 60 kg person. 15 doses of 3 ampules (total of 2250 mg) equals 37.5 mg/kg for a 60 kg person. Receives: Drug: Group 3: Liposomal amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of mucosal lesions
The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. Using a standarized scale we'll qualify from 0 (absent) to 3 (severe) the following items: erythema, edema/swelling, infiltration, erosion/ulceration, in five different places: nasal and perinasal skin, nasal mucosa, palate and oral mucosa, pharynx and larynx. Additionally, changes in voice quality will be registered. 63 will be the maximun score and means severe and massive compromise.
clinical cure: >90% loss of presenting severity score clinical improvement: 50%-90% loss of presenting severity score no clinical change: 25% worsening to 49% improvement in presenting severity score clinically worse: >25% worsening of presenting score or relapse after initial improvement
Measured: Baseline to 12 month follow up
Secondary outcomes (1)
Clinical and laboratory safety of these 3 drugs
The secondary purpose is to determine the tolerance of these regimens. Descriptive statistics will be used to present adverse event data. Continuous variables will be presented as number of observations (n), mean, standard deviation (SD), median, minimum and maximum values. Categorical variables will be presented as counts and percentages.
Adverse effects will be compared between groups by appropriate statistics. During treatment administration clinical symptoms (nausea/vomit/abdominal pain; myalgias/arthralgias; headache/dizziness) and laboratory (AST, alkaline phosphatase, lipase, creatinine, CBC) and EKG (in patients receiving antomony) will be evaluated.
Measured: Base line to 1 month after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. A secondary purpose is to determine the tolerance of these regimens. Patients will be randomized between: Group 1---40 patients. Oral miltefosine. Group 2---40 patients. Intravenous pentavalent antimony (Glucantime) Group 3---40 patients. Intravenous liposomal amphotericin B (Ambisome) Because of the disparate routes of administration, the study will not be blinded for the patients or clinical team. However, the ENT doctor who provides data to calculate the primary endpoint, the mucosal severity score, will be blinded. After treatment, all patients will be followed for 2, 6, 9, and 12 months after the beginning of therapy. In addition, all attempts will be made to effect follow-up at 24 months.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Nacional de Dermatologia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Dermatologico de Jorochito, Centro Nacional de Enfermedades Tropicales CENETROP, ABF Foundation for Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799236
- Sponsor's protocol ID
- ABF-BO-2021-100
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B
- ClinicalTrials.gov ID
- NCT04799236
- Acronym / sponsor ID
- ABF-BO-2021-100
- Conditions
- Mucosal Leishmaniasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundacion Nacional de DermatologiaUniversity, hospital or other
- Collaborators
- Hospital Dermatologico de Jorochito, Centro Nacional de Enfermedades Tropicales CENETROP, ABF Foundation for Medical Research
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 16 Mar 2021 (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.
The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral >>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. A secondary purpose is to determine the tolerance of these regimens. Patients will be randomized between: Group 1---40 patients. Oral miltefosine. Group 2---40 patients. Intravenous pentavalent antimony (Glucantime) Group 3---40 patients. Intravenous liposomal amphotericin B (Ambisome) Because of the disparate routes of administration, the study will not be blinded for the patients or clinical team. However, the ENT doctor who provides data to calculate the primary endpoint, the mucosal severity score, will be blinded. After treatment, all patients will be followed for 2, 6, 9, and 12 months after the beginning of therapy. In addition, all attempts will be made to effect follow-up at 24 months.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Oral Miltefosine | Active comparator | Drug: Group 1: MiltefosineMiltefosine will be administered per os at 150 mg/day [50 mg tid] for 28 days. This is the standard regimen of miltefosine for persons >45 kg. |
| Group 2: Intravenous pentavalent antimony | Active comparator | Drug: Group 2: Pentavalent AntimonyIV pentavalent antimony (meglumine antimoniate) will be administrated at 20 mg x kg x d during 20 consecutive days. Antimony will be diluted in 10 times its volume in 5%Dextrose in destilled water and injected IV in 20 minutes |
| Group 3: Intravenous liposomal amphotericin B | Experimental | Drug: Group 3: Liposomal amphotericin BLAMB will be administered IV at 3 ampules [150 mg] on each of days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Three ampules is the individual dose suggested by Aronson et al [2016] and equals 2.5 mg/kg/dose for a 60 kg person. 15 doses of 3 ampules (total of 2250 mg) equals 37.5 mg/kg for a 60 kg person. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- weight over 45 kg
- Parasitological confirmation of the lesion will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion.
Key exclusion criteria (5 listed)
- Previous treatment for leishmaniasis in the last 12 months
- concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment
- values of complete blood count, liver function (aspartate aminotransferase, alkaline phosphatase), renal function (creatinine), pancreatic function (lipase), or uric acid beyond 1.5 x normal range
- EKG with clinically significant abnormalities
- Women of childbearing age not agreeing with the use of secure reproductive contraception for 4 months after initiating miltefosine therapy.
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 |
|---|---|---|
| Group 1: MiltefosineMiltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days | Drug | Group 1: Oral Miltefosine |
| Group 2: Pentavalent Antimonywill be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes | Drug | Group 2: Intravenous pentavalent antimony |
| Group 3: Liposomal amphotericin B3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses. | Drug | Group 3: Intravenous liposomal amphotericin B |
Primary outcome
Healing of mucosal lesions
Time frame: Baseline to 12 month follow up
The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. Using a standarized scale we'll qualify from 0 (absent) to 3 (severe) the following items: erythema, edema/swelling, infiltration, erosion/ulceration, in five different places: nasal and perinasal skin, nasal mucosa, palate and oral mucosa, pharynx and larynx. Additionally, changes in voice quality will be registered. 63 will be the maximun score and means severe and massive compromise. clinical cure: >90% loss of presenting severity score clinical improvement: 50%-90% loss of presenting severity score no clinical change: 25% worsening to 49% improvement in presenting severity score clinically worse: >25% worsening of presenting score or relapse after initial improvement
1 secondary outcome
Clinical and laboratory safety of these 3 drugs
Time frame: Base line to 1 month after the end of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group 1: Miltefosine, Group 2: Pentavalent Antimony and Group 3: Liposomal amphotericin B in people with Mucosal Leishmaniasis, run by Fundacion Nacional de Dermatologia 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 2 inclusion and 5 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 5 Mar 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 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 phase mean?
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 jaime soto, MD (+59175648894, jasm.dlb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of mucosal lesions (time frame: Baseline to 12 month follow up). 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 5 Mar 2024.