Trial reportThe New England journal of medicine2016
Antimalarial Activity of KAF156 in Falciparum and Vivax Malaria.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph
Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01753323 (A Proof-of-concept, Open Label Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection), which is not on this map. Cited by 53 papers.
0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed
13.9field-weighted citation impact, top 1% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Proof-of-concept, Open Label Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Who cites it
53 citing papers in PubMed, 107 citations in OpenAlex.
- Pharmacokinetics of Ganaplacide and Lumefantrine in Adults, Adolescents, and Children with Plasmodium falciparum Malaria Treated with Ganaplacide Plus Lumefantrine Solid Dispersion Formulation: Analysis of Data from a Multinational Phase 2 Study.Journal of clinical pharmacology · 2025Trial
- Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated Plasmodium falciparum Malaria.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Safety, Pharmacokinetics, and Causal Prophylactic Efficacy of KAF156 in a Plasmodium falciparum Human Infection Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- A phase 1 evaluation of the pharmacokinetic/pharmacodynamic interaction of the anti-malarial agents KAF156 and piperaquine.Malaria journal · 2018Trial
- Safety, tolerability, pharmacokinetics, and activity of the novel long-acting antimalarial DSM265: a two-part first-in-human phase 1a/1b randomised study.The Lancet. Infectious diseases · 2017Trial
- Article
- Drug Interaction Studies of Cabamiquine:Ganaplacide Combination against HepaticACS infectious diseases · 2025Article
- Antimalarial Drug Discovery from Natural and Synthetic Sources.Current medicinal chemistry · 2025Review
- Artemisinin-resistant malaria.Clinical microbiology reviews · 2024Review
- In vitro evaluation of ganaplacide/lumefantrine combination against Plasmodium falciparum in a context of artemisinin resistance.The Journal of antimicrobial chemotherapy · 2024Article
- Plasmodium SEY1 is a novel druggable target that contributes to imidazolopiperazine mechanism of action.Research square · 2024Article
- Article
- Defining the next generation of severe malaria treatment: a target product profile.Malaria journal · 2024Review
- Recent advances, challenges and updates on the development of therapeutics for malaria.EXCLI journal · 2024Review
- Article
- Novel Therapeutics for Malaria.Pharmaceutics · 2023Review
- Comparative Susceptibility of Plasmodium ovale and Plasmodium falciparum Field Isolates to Reference and Lead Candidate Antimalarial Drugs in Ghana.Microbiology spectrum · 2023Article
- Fast-Killing Tyrosine Amide ((ACS infectious diseases · 2023Article
- A NovelAntimicrobial agents and chemotherapy · 2022Article
- Malaria in 2022: Increasing challenges, cautious optimism.Nature communications · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 6 institutions in 6 countries.
Nicholas J WhiteFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Tran T DuongFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Chirapong UthaisinFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
François NostenFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Aung P PhyoFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Borimas HanboonkunupakarnFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Sasithon PukrittayakameeFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Podjanee JittamalaFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Kittiphum ChuthasmitFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Ming S CheungFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Yiyan FengFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Ruobing LiFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Baldur MagnussonFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Marc SultanFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Daniela WieserFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Xiaolei XunFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Rong ZhaoFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Thierry T DiaganaFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Peter PertelFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
F Joel LeongFrom the Mahidol-Oxford Tropical Medicine Research Unit (MORU) (N.J.W.) and the Department of Clinical Tropical Medicine (B.H., S.P., P.J.), Faculty of Tropical Medicine, Mahidol University, Bangkok, Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot (F.N., A.P.P.), Phusing Hospital, 83/1 Tambon Huay Tikchu, Phusing District, Srisaket (K.C.), and Mae Ramat District Hospital, Mae Ramat District, Tak (C.U.) - all in Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom (N.J.W., F.N.); National Institute for Malariology, Parasitology and Entomology, Tu Liem District, Hanoi (D.T.T.); Novartis Institutes for BioMedical Research (M.S.C., M.S., D.W.) and Novartis Pharma (B.M.) - both in Basel, Switzerland; Novartis Institutes for BioMedical Research (Y.F., R.Z.) and Novartis Pharma (China) (X.X.), Shanghai, and Novartis Institutes for BioMedical Research, Beijing (R.L.) - all in China; Novartis Institute for Tropical Diseases, Singapore (T.T.D., F.J.L.); and Novartis Institutes for BioMedical Research, Cambridge, MA (P.P.).
Mahidol Oxford Tropical Medicine Research Unit · THMaesot General Hospital · THNovartis Institutes for BioMedical ResearchNovartis (Singapore) · SGNovartis (United States) · USUniversity of Oxford · GB
Funding
Wellcome Trust 077166
Abstract
backgroundKAF156 belongs to a new class of antimalarial agents (imidazolopiperazines), with activity against asexual and sexual blood stages and the preerythrocytic liver stages of malarial parasites.
methodsWe conducted a phase 2, open-label, two-part study at five centers in Thailand and Vietnam to assess the antimalarial efficacy, safety, and pharmacokinetic profile of KAF156 in adults with acute Plasmodium vivax or P. falciparum malaria. Assessment of parasite clearance rates in cohorts of patients with vivax or falciparum malaria who were treated with multiple doses (400 mg once daily for 3 days) was followed by assessment of the cure rate at 28 days in a separate cohort of patients with falciparum malaria who received a single dose (800 mg).
resultsMedian parasite clearance times were 45 hours (interquartile range, 42 to 48) in 10 patients with falciparum malaria and 24 hours (interquartile range, 20 to 30) in 10 patients with vivax malaria after treatment with the multiple-dose regimen and 49 hours (interquartile range, 42 to 54) in 21 patients with falciparum malaria after treatment with the single dose. Among the 21 patients who received the single dose and were followed for 28 days, 1 had reinfection and 7 had recrudescent infections (cure rate, 67%; 95% credible interval, 46 to 84). The mean (±SD) KAF156 terminal elimination half-life was 44.1±8.9 hours. There were no serious adverse events in this small study. The most common adverse events included sinus bradycardia, thrombocytopenia, hypokalemia, anemia, and hyperbilirubinemia. Vomiting of grade 2 or higher occurred in 2 patients, 1 of whom discontinued treatment because of repeated vomiting after receiving the single 800-mg dose. More adverse events were reported in the single-dose cohort, which had longer follow-up, than in the multiple-dose cohorts.
conclusionsKAF156 showed antimalarial activity without evident safety concerns in a small number of adults with uncomplicated P. vivax or P. falciparum malaria. (Funded by Novartis and others; ClinicalTrials.gov number, NCT01753323 .).
Indexed as
Administration, OralAdultAntimalarialsFemaleFeverHumansImidazolesMalaria, FalciparumMalaria, VivaxMaleMiddle AgedParasite LoadPiperazinesPlasmodium falciparumPlasmodium vivaxYoung AdultAntimalarialsganaplacideImidazolesPiperazines
Identifiers
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Registered trials
NCT01753323ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.