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Recruiting NCT06514560

OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

— Observational Cutaneous Leishmaniases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Miltefosine.
Who it may be relevant to
Registry conditions: Cutaneous Leishmaniases. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ethiopia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Miltefosine
    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

Primary outcome measures

  • 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]
  • 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]
  • 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]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Ethiopia · 1 center
  • Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital — Addis Ababa

Identifiers

NCT: NCT06514560 · 1708/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗