Cutaneous LeishmaniasesOPTIMILEISHNCT06514560
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
Trial summary
While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- Miltefosine
- How many people
- 80 participants
- Where
- 1 siteEthiopia
- Study dates
- 18 Jun 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: A total of 40 children on allometric dosing and 40 other patients will be enrolled in the study
Who may be able to join
- Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis
- Age >2
- Clinical decision to start miltefosine treatment as systemic treatment
- In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant)
- Willing and able to provide informed consent
- Willing to be hospitalized for the duration of treatment
Who cannot join
- Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months
- Pregnant (pregnancy test at D0) or breastfeeding
- Unlikely to come for follow-up visits
- Abnormal lab values Hemoglobin <5.0g/100mL Platelets <50 x 10^9/L White blood count <1 x 10^9/L ASAT/ALAT >3x upper normal range Creatinine above the normal limit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital
Addis Ababa
Shimelis Negusse, MD, 09 11642060 ext. +251, shimelis321@gmail.com
About this study
While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.
Read the detailed description
In this project, parasite dynamics and miltefosine pharmacokinetics in the skin and blood during routine durations of miltefosine treatment (4-8 weeks) are studied with the aim to provide evidence to optimize miltefosine dosing for treatment of CL. By also studying these factors in children who get allometric miltefosine dosing, data which can be used to adapt the current allometric dosing scheme specifically to children with CL will be produced. Exploratory objectives will look into searching for more objective outcome assessment measures, resistance, helminth infection and nutritional status as potential factors affecting treatment response.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- Miltefosine
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
Miltefosine will be prescribed by the treating physician for a minimum of 4 weeks. If treatment response is not sufficient, treatment extension could be decided by the treating physician up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Non-allometric dosing | 40 patients who will not use allometric dosing will be included
miltefosine will be given based on weight: 30-45 kg: 100mg miltefosine per day >45 kg: 150mg miltefosine per day Receives: Drug: Miltefosine | |
| allometric dosing (weight below 30 kg) | 40 patients who weigh less than 30kg and therefore get allometric dosing will be recruited.
Dosing is given based on weight, height, and sex, according to Dorlo et al 2012 Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miltefosine plasma concentrations - Area under the plasma concentration versus time curve (AUC)
Determined by LC-MS/MS, miltefosine pharmacokinetics are assessed through calculation of the area under the plasma concentration-time curve from start of treatment until end of treatment (AUC0-EoT), stratified by whether patients received allometric dosing or not.
Measured: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Miltefosine plasma concentrations - Maximum plasma concentration (Cmax)
Determined by LC-MS/MS, stratified by whether patients received allometric dosing or not.
Measured: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
MIltefosine plasma concentrations - Time of maximum concentration (Tmax)
Determined by LC-MS/MS, stratified by whether patients received allometric dosing or not.
Measured: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Secondary outcomes (4)
Parasite kinetics in blood and skin
To determine parasite kinetics in terms of Ct-values in blood and skin (microbiopsy sample) measured by quantitative PCR
Measured: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Adapted allometric dosing scheme specifically for children with CL
Population PK and PK-PD analysis of the relationship between miltefosine exposure and parasite kinetics will be done at UU, based on results from miltefosine plasma concentrations. Structural pharmacokinetic modelling will be used to develop and simulate alternative dosing schemes for children with CL, using Monte Carlo simulations.
Measured: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Treatment outcomes of patients on miltefosine treatment
Clinical cure rate determined by complete flattening, complete reepithelization and absence of erythema, crustation, and swelling
Measured: Day 28, day 90 and day 180
Assess safety of miltefosine
Side-effects: number and proportion of patients with adverse events
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start18 Jun 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Uppsala University, The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Saskia Van Henten, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514560
- Sponsor's protocol ID
- 1708/23
- Acronym
- OPTIMILEISH
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 23 Jul 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
- ClinicalTrials.gov ID
- NCT06514560
- Acronym / sponsor ID
- OPTIMILEISH / 1708/23
- Conditions
- Cutaneous Leishmaniases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Uppsala University, The Netherlands Cancer Institute
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jul 2024 (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.
While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.
Detailed description
In this project, parasite dynamics and miltefosine pharmacokinetics in the skin and blood during routine durations of miltefosine treatment (4-8 weeks) are studied with the aim to provide evidence to optimize miltefosine dosing for treatment of CL. By also studying these factors in children who get allometric miltefosine dosing, data which can be used to adapt the current allometric dosing scheme specifically to children with CL will be produced. Exploratory objectives will look into searching for more objective outcome assessment measures, resistance, helminth infection and nutritional status as potential factors affecting treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-allometric dosing | – | Drug: Miltefosine40 patients who will not use allometric dosing will be included miltefosine will be given based on weight: 30-45 kg: 100mg miltefosine per day >45 kg: 150mg miltefosine per day |
| allometric dosing (weight below 30 kg) | – | Drug: Miltefosine40 patients who weigh less than 30kg and therefore get allometric dosing will be recruited. Dosing is given based on weight, height, and sex, according to Dorlo et al 2012 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 40 children on allometric dosing and 40 other patients will be enrolled in the study
Key inclusion criteria (6 listed)
- Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis
- Age >2
- Clinical decision to start miltefosine treatment as systemic treatment
- In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant)
- Willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months
- Pregnant (pregnancy test at D0) or breastfeeding
- Unlikely to come for follow-up visits
- Abnormal lab values Hemoglobin <5.0g/100mL Platelets <50 x 10^9/L White blood count <1 x 10^9/L ASAT/ALAT >3x upper normal range Creatinine above the normal limit
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 |
|---|---|---|
| MiltefosineMiltefosine will be prescribed by the treating physician for a minimum of 4 weeks. If treatment response is not sufficient, treatment extension could be decided by the treating physician up to 8 weeks | Drug | Non-allometric dosing, allometric dosing (weight below 30 kg) |
Primary outcome
Miltefosine plasma concentrations - Area under the plasma concentration versus time curve (AUC)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Determined by LC-MS/MS, miltefosine pharmacokinetics are assessed through calculation of the area under the plasma concentration-time curve from start of treatment until end of treatment (AUC0-EoT), stratified by whether patients received allometric dosing or not.
Miltefosine plasma concentrations - Maximum plasma concentration (Cmax)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Determined by LC-MS/MS, stratified by whether patients received allometric dosing or not.
MIltefosine plasma concentrations - Time of maximum concentration (Tmax)
Time frame: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Determined by LC-MS/MS, stratified by whether patients received allometric dosing or not.
4 secondary outcomes
Parasite kinetics in blood and skin
Time frame: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Adapted allometric dosing scheme specifically for children with CL
Time frame: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Treatment outcomes of patients on miltefosine treatment
Time frame: Day 28, day 90 and day 180
Assess safety of miltefosine
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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.
Saskia Van Henten principal investigator
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
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 4 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: looking for participants now, as of the sponsor's last update on 23 Jul 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 Ethiopia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimelis Nigusse, MD (0911642060, shimelis321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miltefosine plasma concentrations - Area under the plasma concentration versus time curve (AUC) (time frame: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180). 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 23 Jul 2024.