Efficacy, safety and tolerability of KAF156 in combination with Lumefantrine Solid Dispersion Formulation (LUM-SDF) in a pediatric population with uncomplicated Plasmodium falciparum malaria
- Conditions
- Malaria
- Registration Number
- PACTR202012535210091
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 224
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method