Project Description: An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria.

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Project Title: An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria.

Project Description: This is an adaptive, multicenter, randomized, open-label, sequential cohort study in participants aged 12 years (Cohorts 1-2) and 2 6 months to < 12 years (Cohorts 3-5) with a diagnosis of moderately severe and severe P. falciparum malaria. This study is investigating the efficacy (parasite reduction and clinical outcome), safety, tolerability and pharmacokinetics of different injectable dose regimens of cipargamin in comparison to injectable artesunate. The first cohort (Cohort 1) will be small, and will... This is an adaptive, multicenter, randomized, open-label, sequential cohort study in participants aged 12 years (Cohorts 1-2) and 2 6 months to < 12 years (Cohorts 3-5) with a diagnosis of moderately severe and severe P. falciparum malaria. This study is investigating the efficacy (parasite reduction and clinical outcome), safety, tolerability and pharmacokinetics of different injectable dose regimens of cipargamin in comparison to injectable artesunate. The first cohort (Cohort 1) will be small, and will include participants aged 12 years or over, diagnosed with moderately severe malaria and high parasitemia. This cohort will be used the for initial evaluation of safety and parasite clearance rates before continuing into Cohorts 2-5, which will include only severe malaria patients according to WHO criteria. Progressively younger participants will be included with each new cohort from Cohort 2 onwards. This design aims at minimizing risks for pediatric participants < 12 years Study objective To assess the efficacy of different doses of intravenous cipargamin vs artesunate by evaluating the proportion of participants with 2 90% reduction of parasitemia at 12 hours post administration of the first dose. Secondary objectives: To assess the clinical outcome as measured by the proportion of participants with clinical success at 48 hours

Principal Investigator : Ally Olotu

Department Name :

Time frame: (2022-09-22) - (2024-10-04)

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