This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult and children VL patients in Eastern Africa.
Who can participate
Age range4 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis
* Patients aged 4 to \< 50 years who are able to comply with the study protocol.
* 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 each country regulatory requirements
Exclusion Criteria:
* Patients who are relapse cases
* Patients with Para-Kala azar dermal leishmaniasis grade 3
* Patients who have received any anti-leishmanial drugs in the last 6 months
* Patients with severe malnutrition (for children aged \<5 years: weight-for-height WHO reference curves by sex, z score \<-3; for children patients 5-18 years: BMI-for-age WHO reference curves by sex, z score \< -3; for adults \>18 years: BMI \< 16)\*
* Patients with positive HIV diagnosis
* Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments
* Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG
* Patients suffering from a concomitant severe infection such as TB, schistosomiasis or any other serious underlying disease (e.g. cardiac, renal, hepatic) or chronic condition which would preclude evaluation of the patient's response to study medication
* Pregnant or lactating women
* Female patien…