Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06514560
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
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06514560
Study Brief:
Protocol Section:
NCT06514560