Clinical Research Directory

Inclusion Criteria: * Parasitological (microscopy, culture or PCR) confirmation of leishmaniasis * Age ≥4 and ≤65 years old * Need systemic treatment based on meeting at least one of the following criteria: \>4 lesions/ At least one with lesion size \>4cm/ Mucosal involvement, or at risk for mucosal involvement (\<1 cm from the nose, eyes or vermillion border of the lips)/ Previous failure of lesion-directed treatment /Lesions on areas not suitable for lesion-directed therapy (e.g. joints, eyelids, fingers)/ Deep or extensive lesion(s) with risk of functional impairment * Informed consent provided, as follows: For patients ≥18 years of age: Patient is willing and able to provide informed consent. / For patients aged 8 to 17 years (inclusive): Parent or caregiver is willing and able to provide informed consent, and patient is willing and able to provide assent / For patients aged 4 to 7 years (inclusive): Parent or caregiver is willing and able to provide informed consent. * Willing and able to be hospitalized for the duration of treatment * Willing and able to attend all follow-up visits * If female and of child-bearing age: willing to take contraceptives during treatment and for 5 months after EoT (parenteral, intrauterine device (IUD) or implant). Note that actually taking the contraceptives is only required when randomized in an investigational arm containing miltefosine. Exclusion Criteria: * Pregnant (positive pregnancy test at screening) or breastfeeding * Any known severe medical comorbidities, or signs and symptoms of severe disease, that in the opinion of the investigator disqualifies the patient of being enrolled in the trial or precludes evaluation of the patient's response to the study medication. Examples are: Severe known active infections such as tuberculosis, schistosomiasis, malaria, hepatitis B virus, active hepatitis C virus/ Serious underlying disease (e.g. cardiac, renal, hepatic (including diabetes mellitus) or chronic disease/ Immunocompromising conditions: transplant patients, or patients receiving immunosuppressant medication/ Pre-existing ocular conditions evaluated at baseline: e.g. keratitis, uveitis, scleritis/ Pre-existing sensorineural hearing loss evaluated at baseline, or previously diagnosed with ototoxicity * HIV Infection * Severe malnutrition: ≤5 years old: Mean upper arm circumference (MUAC) \<115mm/ 6-10 years old: MUAC \<135mm/ 11-17 years old: MUAC \<160mm/ ≥ 18 years old: Body mass index (BMI) \<16kg/m² * (History of) ECG abnormalities: Clinically significant cardiac arrythmias: e.g. 2nd degree or 3rd degree AV block without pacemaker, sustained ventricular tachycardia/ Prolonged QTc interval \>450ms * Lab abnormalities: Haemoglobin \<5.0g/dL/ Platelets \<50 x 10\^9/L/ White blood count \<1 x 10\^9/L / Alanine aminotransferase (AST) / aspartate aminotransferase (ALT) \>3x upper limit of normal (ULN)/ Serum creatinine \>1.5 x ULN/ Bilirubin \>1.5 x ULN/ Fasting blood glucose (preferred) \>7mmol/L (126mg/dl) or blood glucose \>11.1 mmol/L (200mg/dl) at any time/ Potassium \<3.5mmol/L * Having received any allopathic treatment for CL lesion(s) in the past 6 months: cryotherapy, thermotherapy, SSG, meglumine antimoniate, paromomycin, pentamidine, liposomal amphotericin B, non-liposomal amphotericin B, miltefosine * Diffuse cutaneous leishmaniasis (DCL) * Patients on treatment with any of the prohibited medications, which are any treatments with the potential to influence lesion healing, skin condition, or participant safety. This includes any form of chemotherapy, antituberculosis medication, systemic antibiotics or antifungals, antivirals, corticosteroids and immunosuppressants. Topical antibiotics or antifungals are allowed as long as they are not applied on any of the CL lesions. * Onset of lesions \>24 months ago * Known allergies or serious adverse reactions to one of the study components/medications * Any other condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the patient or prevent, limit or confound protocol-specified assessments