Clinical Research Directory

Inclusion Criteria: * Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis. * Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for patients under 18 years of age (in the case of minors, assent from the children also needs to be obtained as per country regulatory requirements). Exclusion Criteria: VL cases will not be enrolled in the study if any of the following exclusion criteria apply: * Patients who are cases of VL relapse, post- or para-kala-azar dermal leishmaniasis or who have received any anti-leishmanial drugs within the last six months. * Patients not eligible for treatment with SSG+PM: * Patients with severe malnutrition. * Patients with positive HIV diagnosis. * Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments (SSG or PM). * Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG. * Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic), or chronic condition which would preclude evaluation of the patient's response to study medication. * Patients who cannot comply with the planned procedures and scheduled visits of the study protocol.