Status:
RECRUITING
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Conditions:
Cutaneous Leishmaniases
Eligibility:
All Genders
2+ years
Brief 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 lac...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06514560
Start Date
June 18 2024
End Date
December 30 2026
Last Update
July 23 2024
Active Locations (1)
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1
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital
Addis Ababa, Ethiopia