OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
ConditionCutaneous Leishmaniases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorInstitute of Tropical Medicine, Belgium
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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 design
Treatments tested in this trial
- Miltefosine
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Institute of Tropical Medicine, Belgium
Lead sponsor
Alert Hospital, Ethiopia
Collaborator
Armauer Hansen Research Institute, Ethiopia
Collaborator
Uppsala University
Collaborator
The Netherlands Cancer Institute
Collaborator
Source ClinicalTrials.gov