Testing KLU156 for treating uncomplicated malaria in adults and 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 study evaluates the efficacy, safety, and tolerability of KLU156, a combination of ganaplacide and lumefantrine, in treating uncomplicated Plasmodium falciparum malaria in patients aged 2 months and older. Participants will receive the treatment once daily for three days, with follow-up assessments to monitor their health and response to the medication. The study includes a core phase lasting 43 days and an extension phase of up to 24 months for those who tolerate the treatment well. The goal is to demonstrate that KLU156 is as effective as the standard treatment, Coartem.

Why it matters

Who can join: the full rules

Key Inclusion criteria (Core phase)

1. Male or female patients ≥ 5 kg of body weight and ≥ 2 months of age
2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/µL at the time of pre-screening with or without other Plasmodium spp. co-infection.
3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally)
4. Negative pregnancy test for patients of childbearing potential
5. Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards
6. The patient and/or their 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.

Key Exclusion criteria (Core phase)

1. Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)
2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)
3. Severe malnutrition. For patients ≥ 12 years: body mass index (BMI) \< 16.0. For children \< 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC \< 115 mm)
4. Repeated vomiting (defined as \> 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as \> 3 watery stools in the 24 hours prior to start of screening)
5. Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia
6. Anemia (hemoglobin level \<7 g/dL)
7. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment), or which may jeopardize the patient in case of participation in the study.
8. Any of the following:

   * Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) \> 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin
   * Total bilirubin \> 3 x ULN
   * Resting QT interval corrected by Fridericia's formula (QTcF) \> 450 ms at screening
9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown)
10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease
11. Pregnant or nursing (lactating) patients.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Novartis Investigative Site
  Banfora, Burkina Faso Recruiting
• Novartis Investigative Site
  Bobo Dioulasso, Burkina Faso Recruiting
• Novartis Investigative Site
  Nanoro, Burkina Faso Recruiting
• Novartis Investigative Site
  Ouagadougou, Burkina Faso Recruiting
• Novartis Investigative Site
  Sabou, Burkina Faso Recruiting
• Novartis Investigative Site
  Commune De La Kenya Lubumbashi, Du Haut Katanga, Congo, The Democratic Republic of the Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: Novartis.email@novartis.com
• Phone: +41613241111

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.