This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
The Cohort C2 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a single oral dose of up to three anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in children aged 2 to \<12 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
oral capsules administered in combination with KLU156
Standard of Care
oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)
Novartis Investigative Site
Banfora, Burkina Faso
RECRUITINGNovartis Investigative Site
Nanoro, Burkina Faso
NOT_YET_RECRUITINGPolymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
Time frame: Day 29
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral anti malarial agent versus the standard of care (SoC) in participants with uncomplicated P. falciparum malaria
Time frame: up to Day 7
PCR-uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC in participants with uncomplicated P. falciparum malaria.
Time frame: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Time to reach maximum observed concentration (Tmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Elimination half-life (T1/2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Abidjan, Côte d’Ivoire
RECRUITINGNovartis Investigative Site
Azaguié, Côte d’Ivoire
RECRUITINGNovartis Investigative Site
Lambaréné, Gabon
NOT_YET_RECRUITINGNovartis Investigative Site
Libreville, Gabon
NOT_YET_RECRUITINGNovartis Investigative Site
Kintampo, Ghana
NOT_YET_RECRUITINGNovartis Investigative Site
Navrongo, Ghana
NOT_YET_RECRUITINGNovartis Investigative Site
Ahero, Kenya
NOT_YET_RECRUITINGNovartis Investigative Site
Kisumu, Kenya
NOT_YET_RECRUITING...and 3 more locations
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Total body clearance (CL/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Apparent volume of distribution (V/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Area under the concentration-time curve (AUC0-t)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8