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Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
Led by Novartis Pharmaceuticals · Updated on 2025-07-30
327
Participants Needed
12
Research Sites
126 weeks
Total Duration
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AI-Summary
What this Trial Is About
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
CONDITIONS
Official Title
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years and older for Part A, 12 years and older for Part B, and 2 to under 12 years for Part C at screening
- Confirmed acute uncomplicated P. falciparum malaria mono infection with parasite count between 5,000 to 150,000 asexual parasites/µl for Part A and 1,000 to 150,000 for Parts B and C
- Weight between 40 kg and 90 kg for Part A, between 35 kg and 90 kg for Part B, and at least 10 kg for Part C at screening
- Axillary temperature of 37.5ºC or higher, or oral/tympanic/rectal temperature of 38.0ºC or higher, or history of fever in the previous 24 hours
You will not qualify if you...
- Signs or symptoms of severe or complicated malaria, or mixed Plasmodium infection at screening
- Moderate to severe anemia, chronic hemoglobinopathy, or known chronic diseases such as sickle cell disease
- Clinically significant liver disease or abnormal liver function tests exceeding defined limits
- Known or suspected immunosuppressive or immunodeficient conditions including HIV infection
- Pregnant or nursing women, or women of child-bearing potential not using effective contraception
- History or current diagnosis of significant ECG abnormalities or cardiac arrhythmias such as sustained ventricular tachycardia or second/third degree AV block without a pacemaker
- Resting heart rate below 50 bpm
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Novartis Investigative Site
Banfora, Burkina Faso
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2
Novartis Investigative Site
Nanoro, Burkina Faso, BP 18
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3
Novartis Investigative Site
Abidjan, Côte d’Ivoire, 13BP972
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4
Novartis Investigative Site
Azaguié, Côte d’Ivoire, BP 173
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5
Novartis Investigative Site
Lambaréné, Gabon, BP 242
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6
Novartis Investigative Site
Libreville, Gabon, BP 1437
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7
Novartis Investigative Site
Kintampo, Ghana, 92037
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8
Novartis Investigative Site
Navrango, Ghana, VWJ6+8WF
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9
Novartis Investigative Site
Ahero, Kisumu County, Kenya, 40100
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10
Novartis Investigative Site
Kisumu, Kenya, 40100
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11
Novartis Investigative Site
Kampala, Uganda
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12
Novartis Investigative Site
Tororo, Uganda, 10102
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Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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