Single-dose combination therapy for uncomplicated malaria in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is Cohort C2 of a platform study evaluating a two-arm, open-label regimen for uncomplicated malaria. It compares a single-dose combination therapy containing KAE609 and potentially other agents (KLU156) to the standard of care Coartem (artemether-lumefantrine) in children aged 2 to under 12 years. Participants must have mono-infection with P. falciparum and a parasitemia within defined limits, and meet weight criteria. The trial is conducted at multiple Novartis investigative sites and aims to assess efficacy and safety of the combination versus standard therapy. It is a Phase 2, randomized, controlled, open-label design within a platform study framework.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female participants 2 to \<12 years of age at screening.
2. Participants must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 1,000 to 150,000 asexual parasite count/μl of blood for P. falciparum.
3. Participants must weigh at least 10 kg at screening.

Exclusion Criteria:

1. Participants with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:

   * AST/ALT \> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
   * AST/ALT \> 1.5 and ≤ 2 x ULN and total bilirubin is \> ULN
   * Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT
4. Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:

   * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
   * History of familial long QT syndrome or known family history of Torsades de Pointe.
   * Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Novartis Investigative Site
  Banfora, Burkina Faso Recruiting
• Novartis Investigative Site
  Nanoro, Burkina Faso Recruiting
• Novartis Investigative Site
  Abidjan, Côte d’Ivoire Recruiting
• Novartis Investigative Site
  Azaguié, Côte d’Ivoire Recruiting
• Novartis Investigative Site
  Kigali, Rwanda Recruiting
• Novartis Investigative Site
  Lambaréné, Gabon Not yet recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +1 888 669 6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.