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
  • [11] Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children
    Nambozi, Michael
    Van Geertruyden, Jean-Pierre
    Hachizovu, Sebastian
    Chaponda, Mike
    Mukwamataba, Doreen
    Mulenga, Modest
    Ubben, David
    D'Alessandro, Umberto
    MALARIA JOURNAL, 2011, 10
  • [12] Safety, efficacy and population pharmacokinetics of fixed-dose combination of artesunate-mefloquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in India
    Valecha, Neena
    Srivastava, Bina
    Dubhashi, N. G.
    Rao, B. H. Krishnamoorthy
    Kumar, Ashwani
    Ghosh, S. K.
    Singh, Jai Prakash Narayan
    Kiechel, J. R.
    Sharma, Bhawna
    Jullien, V.
    Dash, A. P.
    Taylor, W. R. J.
    Anvikar, Anupkumar R.
    JOURNAL OF VECTOR BORNE DISEASES, 2013, 50 (04) : 258 - 264
  • [13] A phase II, open label, study of the safety, tolerability, efficacy and pharmacokinetics of intravenous artesunate in adults with uncomplicated malaria
    Remich, Shon A.
    Polhemus, Mark
    Otieno, Walter
    Ogutu, Bernhards
    Weina, Peter
    Miller, Robert S.
    AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE, 2006, 75 (05): : 224 - 224
  • [14] Efficacy and safety of dihydroartemisinin-piperaquine for treatment of uncomplicated Plasmodium falciparum malaria in endemic countries: meta-analysis of randomised controlled studies
    Naing, Cho
    Mak, Joon Wah
    Aung, Kyan
    Wong, Jadon Y. R.
    TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, 2013, 107 (02) : 65 - 73
  • [15] A randomised trial to assess the safety and efficacy of artemether-lumefantrine (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwanda
    Fanello, C. I.
    Karema, C.
    van Doren, W.
    van Overmeir, Chantal
    Ngamije, D.
    D'Alessandro, U.
    TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, 2007, 101 (04) : 344 - 350
  • [16] Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate in comparison with chloroquine phosphate in children with acute uncomplicated Plasmodium vivax malaria: A phase III, randomised, multicentric study
    Valecha, Neena
    Goyal, Vimal Kant
    Mishra, Deo Nidhi
    Das, Rashmi Ranjan
    Jauhri, Neeraj
    Bhardwaj, Alok Chandra
    Khurana, Omesh
    Choudhury, Reena
    Pandey, Madhukar
    Baliga, Bantwal Shantharam
    Ghosh, Susanta Kumar
    Srivastava, Bina
    Soans, Santhosh T.
    Bahl, Raj Kamal
    Punj, Ajay
    Roy, Arjun
    Sharma, Sanjay K.
    Nasa, Amit
    Jalali, Rajinder K.
    Anvikar, Anupkumar R.
    JOURNAL OF VECTOR BORNE DISEASES, 2020, 57 (03) : 213 - 220
  • [17] CHLORPROGUANIL-DAPSONE-ARTESUNATE VS. CHLORPROGUANIL-DAPSONE: A RANDOMISED, DOUBLE-BLIND PHASE III TRIAL FOR THE TREATMENT OF ACUTE UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA
    Tiono, Alfred
    Dicko, Alassane
    Ndububa, Dennis A.
    Abenyega, Tsiri
    Pitmang, Simon
    Awobusuyi, Jacob
    Pamba, Allan
    Duparc, Stephan
    Goh, Li-Ean
    Harrell, Emma
    Carter, Nick
    Ward, Stephen A.
    Greenwood, Brian
    Winstanley, Peter A.
    AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE, 2008, 79 (06): : 172 - 172
  • [18] Safety and mosquitocidal efficacy of high-dose ivermectin when co-administered with dihydroartemisinin-piperaquine in Kenyan adults with uncomplicated malaria (IVERMAL): a randomised, double-blind, placebo-controlled trial
    Smit, Menno R.
    Ochomo, Eric O.
    Aljayyoussi, Ghaith
    Kwambai, Titus K.
    Abong'o, Bernard O.
    Chen, Tao
    Bousema, Teun
    Slater, Hannah C.
    Waterhouse, David
    Bayoh, Nabie M.
    Gimnig, John E.
    Samuels, Aaron M.
    Desai, Meghna R.
    Phillips-Howard, Penelope A.
    Kariuki, Simon K.
    Wang, Duolao
    Ward, Steve A.
    ter Kuile, Feiko O.
    LANCET INFECTIOUS DISEASES, 2018, 18 (06): : 615 - 639
  • [19] Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial
    Sissoko, Mahamadou S.
    Healy, Sara A.
    Katile, Abdoulaye
    Omaswa, Freda
    Zaidi, Irfan
    Gabriel, Erin E.
    Kamate, Bourama
    Samake, Yacouba
    Guindo, Merepen A.
    Dolo, Amagana
    Niangaly, Amadou
    Niare, Karamoko
    Zeguime, Amatigue
    Sissoko, Kourane
    Diallo, Hama
    Thera, Lsmaila
    Ding, Kelly
    Fay, Michael P.
    O'Connell, Elise M.
    Nutman, Thomas B.
    Wong-Madden, Sharon
    Murshedkar, Tooba
    Ruben, Adam J.
    Li, Minglin
    Abebe, Yonas
    Manoj, Anita
    Gunasekera, Anusha
    Chakravarty, Sumana
    Sim, B. Kim Lee
    Billingsley, Peter F.
    James, Eric R.
    Walther, Michael
    Richie, Thomas L.
    Hoffman, Stephen L.
    Doumbo, Ogobara
    Duffy, Patrick E.
    LANCET INFECTIOUS DISEASES, 2017, 17 (05): : 498 - 509
  • [20] Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial
    Tshefu, Antoinette K.
    Gaye, Oumar
    Kayentao, Kassoum
    Thompson, Ricardo
    Bhatt, Kirana M.
    Sesay, Sanie S. S.
    Bustos, Dorina G.
    Tjitra, Emiliana
    Bedu-Addo, George
    Borghini-Fuhrer, Isabelle
    Duparc, Stephan
    Shin, Chang Sik
    Fleckenstein, Lawrence
    LANCET, 2010, 375 (9724): : 1457 - 1467