Malaria
Conditions
Interventions
IV KAE609
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1: Participants aged = 12 years with moderately severe malaria as defined in (prostration and/or repeated vomiting) without presence of other signs of severe malaria (and with high P. falciparum parasitemia (60,000-250,000 parasites per µl) Subsequent Cohorts 2 to 5: Participants diagnosed with severe malaria as defined in modified version of WHO criteria and P. falciparum parasite count of = 5000 per µl Cohort 2: Participants aged = 12 years Cohort 3: Participants aged 6 - < 12 years Cohort 4: Participants aged 2 - < 6 years Cohort 5: Participants aged = 6 months - < 2 years
Exclusion criteria
Exclusion criteria: To all Cohorts 1 to 5: - Mixed Plasmodium infections - Treatment with quinine or artemisinin derivative or any other antimalarial drug or any antibiotic with known antimalarial activity within 12 hours of screening - Signs/symptoms of severe malnutrition in accordance with WHO guidelines: 1. Under 18 years: 5 x the upper limit of normal range (ULN), regardless the level of total bilirubin - Total bilirubin is > 3 mg/dL - Body weight of 75 kg for Cohort 2: - Body weight of 75 kg - moderately severe malaria due to repeated vomiting without presence of any of the symptoms of severe malaria for Cohorts 3 to 5: - Body weight of < 5 kg - moderately severe malaria due to repeated vomiting without presence of any of the symptoms of severe malaria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving at least 90% reduction in Plasmodium falciparum (P. falciparum) at 12 hours [ Time Frame: Day 1 (12 Hours) ] A blood draw will be performed at each collection time point for parasitemia assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants achieving clinical success over time [ Time Frame: Day 3 (48 Hours), Day 4 to Day 29 ] Clinical success is a composite endpoint based on following criterias: a.Is participant dead or alive b.Presence of asexual parasites (yes/no) c.Presence of any of the key signs of severe malaria (yes/no) ;2. Percentage of participants with individual signs of severe malaria over time [ Time Frame: Day 1 to Day 29 ] Individual signs of severe malaria over time will be monitored for the presence of the following signs of severe malaria during the entire study duration: a.Altered consciousness - Prostration or GCS 5 years / BCS 3xULN or > 3 mg/dL or need for renal replacement therapy c.Acidosis - Serum lactate > 4 mmol/L d.Respiratory distress - present or absent e.Severe anemia - Hb 3 g/dl g.Hypoglycemia- plasma glucose 390 U/L, or an increase of >= 10% above baseline occurring up to Day 8 of the study. Delayed hemolytic anemia might occur > 7 days after initiation of parenteral study drug (IV artesunate or IV cipargamin) during the study period. The event is characterized by a 10% or greater decrease in hemoglobin levels accompanied by increase of LDH levels to >390 U/L, or an increase of >= 10% compared to the values measured at Day 8 of the study. ;4.Percentage of participants with neurological sequelae at Day 29 [ Time Frame: Day 29 ] Detailed neurological examination will be conducted and relevant medical history collected under the following categories to assess the extent of neurological signs and symptoms at baseline and to monitor the extent of neurological sequelae in follow-up visits: a.Consciousness b.Cranial Nerve Palsy c.Motor system d.Convulsions e.Sense organs (Examination more useful at time of hospital discharge and in follow-up visits) ;5.Percentage of participants achieving at least 90% reduction in Plasmodium falciparum (P. falciparum) [ Time Frame: Day 2 (24 hours), Day 3 (48 hours) ] A blood draw will b | — |
Countries
Burkina Faso, Cote Divoire, Democratic Republic of the Congo, Gabon, India, Kenya, Mozambique, Nigeria, Rwanda, Uganda
Contacts
Public ContactKanan Jhala
Global Trial Director
Outcome results
None listed