A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria

被引:0
|
作者
Fiona Macintyre
Yeka Adoke
Alfred B. Tiono
Tran Thanh Duong
Ghyslain Mombo-Ngoma
Marielle Bouyou-Akotet
Halidou Tinto
Quique Bassat
Saadou Issifou
Marc Adamy
Helen Demarest
Stephan Duparc
Didier Leroy
Bart E. Laurijssens
Sophie Biguenet
Afizi Kibuuka
Antoinette Kitoto Tshefu
Melnick Smith
Chanelle Foster
Illse Leipoldt
Peter G. Kremsner
Bui Quang Phuc
Alphonse Ouedraogo
Michael Ramharter
机构
[1] Medicines for Malaria Venture,Infectious Diseases Research Collaboration
[2] Tororo Hospital,Universite des Sciences de la Sante Gabon, Département de Parasitology, Malaria Clinical and Operational Research Unit
[3] Centre National de Recherche et de Formation sur le Paludisme,Centre de Recherche du Centre Hospitalier de Mont Amba, Kinshasa School of Public Health
[4] National Institute of Malariology,Department of Medicine I, Division of Infectious Diseases
[5] Parasitology and Entomology,undefined
[6] Centre de Recherches Médicales de Lambaréné,undefined
[7] Institut für Tropenmedizin,undefined
[8] Universität Tübingen,undefined
[9] Melen Hospital,undefined
[10] Institut de Recherche en Sciences de la Santé – Unité de Recherche Clinique de Nanoro,undefined
[11] ISGlobal,undefined
[12] Barcelona Ctr. Int. Health Res. (CRESIB),undefined
[13] Hospital Clínic - Universitat de Barcelona,undefined
[14] Centro de Investigação em Saúde de Manhiça (CISM),undefined
[15] ICREA,undefined
[16] Pediatric Infectious Diseases Unit,undefined
[17] Pediatrics Department,undefined
[18] Hospital Sant Joan de Déu (University of Barcelona),undefined
[19] Universidad Europea de Madrid,undefined
[20] Centre de Recherche sur le Paludisme Associé à la Grossesse et l’Enfance,undefined
[21] Faculte Des Sciences De La Sante,undefined
[22] BEL Pharm Consulting,undefined
[23] University of Kinshasa,undefined
[24] QuintilesIMS,undefined
[25] Department: Biostatistics,undefined
[26] Medical University of Vienna,undefined
[27] Bernhard Nocht Hospital for Tropical Diseases,undefined
[28] Bernhard Nocht Institute for Tropical Medicine and University Medical Center Hamburg-Eppendorf,undefined
来源
BMC Medicine | / 15卷
关键词
Artefenomel; OZ439; Piperaquine; Single dose combination treatment; Pharmacokinetics; Dose–response; modelling and simulation; Phase II B; Uncomplicated ; malaria; Children;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
相关论文
共 50 条
  • [41] Herba Artemisiae annuae tea preparation compared to sulfadoxine-pyrimethamine in the treatment of uncomplicated falciparum malaria in adults:: a randomized double-blind clinical trial
    Blanke, Christoph H.
    Naisabha, Godson B.
    Balema, Mussa B.
    Mbaruku, Godfrey M.
    Heide, Lutz
    Mueller, Markus S.
    TROPICAL DOCTOR, 2008, 38 (02) : 113 - 116
  • [42] Single low-dose tafenoquine combined with dihydroartemisinin-piperaquine to reduce Plasmodium falciparum transmission in Ouelessebougou, Mali: a phase 2, single-blind, randomised clinical trial
    Stone, Will
    Mahamar, Almahamoudou
    Smit, Merel J.
    Sanogo, Koualy
    Sinaba, Youssouf
    Niambele, Sidi M.
    Sacko, Adama
    Keita, Sekouba
    Dicko, Oumar M.
    Diallo, Makonon
    Maguiraga, Seydina O.
    Samake, Siaka
    Attaher, Oumar
    Lanke, Kjerstin
    Ter Heine, Rob
    Bradley, John
    McCall, Matthew B. B.
    Issiaka, Djibrilla
    Traore, Sekou F.
    Bousema, Teun
    Drakeley, Chris
    Dicko, Alassane
    LANCET MICROBE, 2022, 3 (05): : E336 - E347
  • [43] Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial
    Sohn, Il Suk
    Kim, Chong-Jin
    Ahn, Taehoon
    Youn, Ho-Joong
    Jeon, Hui-Kyung
    Ihm, Sang Hyun
    Cho, Eun Joo
    Chung, Woo-Baek
    Chae, Shung Chull
    Kim, Woo-Shik
    Nam, Chang-Wook
    Park, Seong-Mi
    Choi, Ji-Yong
    Kim, Young-Kwon
    Hong, Taek-Jong
    Lee, Hae-Young
    Cho, Jang-Hyun
    Shin, Eun-Seok
    Yoon, Jung-Han
    Yang, Tae-Hyun
    Jeong, Myung-Ho
    Lee, Jun-Hee
    Park, Joong-Il
    CLINICAL THERAPEUTICS, 2017, 39 (08) : 1628 - 1638
  • [44] Efficacy and Safety of Pyronaridine-Artesunate plus Single-Dose Primaquine for Treatment of Uncomplicated Plasmodium falciparum Malaria in Eastern Cambodia
    Leang, Rithea
    Mairet-Khedim, Melissa
    Chea, Huch
    Huy, Rekol
    Khim, Nimol
    Bouth, Denis Mey
    Bustos, Maria Dorina
    Ringwald, Pascal
    Witkowski, Benoit
    ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2019, 63 (03)
  • [45] Results of a randomised, multicentre, phase II, dose-ranging clinical study to assess the safety and efficacy of fixed dose, orally administered pyronaridine and artesunate in adult patients with acute uncomplicated Plasmodium falciparum malaria
    Looareesuwan, Sornchai
    Gaye, Oumar
    Tjitra, Emiliana
    Bojang, Kalifa
    Socheat, Duong
    Pioia, Patrice
    AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE, 2007, 77 (05): : 287 - 287
  • [46] Tolerance and therapeutic efficacy of amodiaquine, sulfadoxine-pyrimethamine and their combination for treatment of uncomplicated Plasmodium falciparum malaria in Bobo-Dioulasso, Burkina Faso:: a randomised clinical trial
    Assogba, F.
    Zigani, H.
    Zongo, I.
    Rouamba, N.
    Ouedraogo, J. B.
    TROPICAL MEDICINE & INTERNATIONAL HEALTH, 2007, 12 : 170 - 170
  • [47] Chlorproguanil-Dapsone-Artesunate versus Artemether-Lumefantrine: A Randomized, Double-Blind Phase III Trial in African Children and Adolescents with Uncomplicated Plasmodium falciparum Malaria
    Premji, Zul
    Umeh, Rich E.
    Owusu-Agyei, Seth
    Esamai, Fabian
    Ezedinachi, Emmanuel U.
    Oguche, Stephen
    Borrmann, Steffen
    Sowunmi, Akintunde
    Duparc, Stephan
    Kirby, Paula L.
    Pamba, Allan
    Kellam, Lynda
    Guiguemde, Robert
    Greenwood, Brian
    Ward, Stephen A.
    Winstanley, Peter A.
    PLOS ONE, 2009, 4 (08):
  • [48] A randomised trial comparing efficacy and safety of artesunate-amodiaquine given as combined or individual therapies for the treatment of acute, uncomplicated Plasmodium falciparum malaria in children in Burkina Faso
    Sirima, S. B.
    Tono, A. B.
    Gansane, A.
    Diarra, A.
    Ouedraogo, A.
    Konate, A. T.
    Morgan, C.
    Kiechel, J. R.
    Taylor, R. W.
    TROPICAL MEDICINE & INTERNATIONAL HEALTH, 2007, 12 : 119 - 119
  • [49] Artesunate and sulfadoxine-pyrimethamine combinations for the treatment of uncomplicated Plasmodium falciparum malaria in Uganda:: a randomized, double-blind, placebo-controlled trial
    Priotto, G
    Kabakyenga, J
    Pinoges, L
    Ruiz, A
    Eriksson, T
    Coussement, F
    Ngambe, T
    Taylor, WRJ
    Perea, W
    Guthmann, JP
    Olliaro, P
    Legros, D
    TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, 2003, 97 (03) : 325 - 330
  • [50] Efficacy of artesunate plus chloroquine for the treatment of uncomplicated malaria in children in Burkina Faso:: a double-blind, randomized, controlled trial
    Sirima, SB
    Tiono, AB
    Konaté, A
    Diarra, A
    Castelli, F
    Pinoges, L
    Mugittu, K
    Taylor, WRJ
    Olliaro, PL
    TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, 2003, 97 (03) : 345 - 349