Actively Recruiting
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
Led by Institute of Tropical Medicine, Belgium · Updated on 2024-07-23
80
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
I
Institute of Tropical Medicine, Belgium
Lead Sponsor
A
Alert Hospital, Ethiopia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis
- Age over 2 years
- Clinical decision to start miltefosine treatment as systemic treatment
- Females of child-bearing age willing to use contraceptives for 6 months (parenteral, IUD, or implant)
- Willing and able to provide informed consent
- Willing to be hospitalized for the duration of treatment
You will not qualify if you...
- Currently on treatment or received modern treatment for leishmaniasis in the last 3 months
- Pregnant or breastfeeding
- Unlikely to attend follow-up visits
- Abnormal laboratory values: Hemoglobin less than 5.0 g/100mL, Platelets less than 50 x 10^9/L, White blood count less than 1 x 10^9/L, ASAT/ALAT greater than 3 times upper normal limit, Creatinine above normal limit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital
Addis Ababa, Ethiopia
Actively Recruiting
Research Team
S
Shimelis Nigusse, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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