Malaria
Conditions
Interventions
KAF156 and Lumefantrine SDF
None
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - In Run-in Cohort: Male and female patients 12 to < 18 years of age, with a body weight = 35.0 kg - In Cohort 1: Male and female patients 2 to < 12 years of age, with a body weight = 10.0 kg - In Cohort 2: Male and female patients 6 months to < 2 years of age, with a body weight = 5.0 kg - Microscopic confirmation of P. falciparum by Giemsa-stained thick and thin films - P. falciparum parasitemia of = 1,000 and = 150,000 parasites/µL at the time of pre-screening - Axillary temperature = 37.5 ºC or oral/tympanic/rectal temperature = 38.0 ºC; or history of fever during the previous 24 hours (at least documented verbally) - The patient and his/her parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned
Exclusion criteria
Exclusion criteria: - Mixed Plasmodium infections. - Signs and symptoms of severe malaria - Significant, nonplasmodial co-infections including tuberculosis - Patients with concurrent febrile illnesses - Known relevant liver disease - Major congenital defects - Any confirmed or suspected immunosuppressive or immunodeficient condition 8. Immunosuppressive therapy within 3 months prior to recruitment. - Repeated vomiting or severe diarrhea - Active duodenal ulcer, ulcerative colitis, Crohn’s disease, chronic use of non-steroidal anti-inflammatory drugs - Clinically relevant abnormalities of electrolyte balance which require correction - Anemia - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the patient in case of participation in the study - Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening - Creatinine > 2 x ULN in the absence of dehydration. In case of dehydration, creatinine should be < 2 x ULN after oral/parenteral rehydration - Known chronic underlying disease such as sickle cell disease, and severe cardiac, renal, or hepatic impairment - Known active or uncontrolled thyroid disease - History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval - Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR-corrected adequate clinical and parasitological response (ACPR) at Day 29 (Cohorts 1 and 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| KAF156 PK parameters such as AUC0-24, Tmax and Cmax (Run-in Cohort);LUM PK parameters such as AUC0-24h, Tmax and Cmax (Run-in Cohort);Standard safety/tolerability assessments: Adverse events (AE)/serious adverse events (SAE) incidence and severity, laboratory abnormalities and electrocardiogram (ECG) abnormalities;KAF156 and lumefantrine: PK parameters such as AUC0-24h, Cmax (LUM Cmax for Cohorts 1 and 2), C168 h and Tmax;PCR-corrected adequate clinical and parasitological response (ACPR) at Days 15 and 29 (Run-in Cohort) and Day 43, and the uncorrected ACPR at Days 15, 29 and 43. Incidence rate of recrudescence and reinfection. Parasite and fever clearance Times (PCT and FCT). | — |
Countries
Burkina Faso, Gabon, Mali
Contacts
Public ContactNovartis Pharma AG
Trial Director
Outcome results
None listed