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
  • [21] Azithromycin combination therapy with artesunate or quinine for the treatment of uncomplicated Plasmodium falciparum malaria in adults:: A randomized, phase 2 clinical trial in Thailand
    Noedl, Harald
    Krudsood, Srivicha
    Chalermratana, Kobsiri
    Silachamroon, Udomsak
    Leowattana, Wattana
    Tangpukdee, Noppadon
    Looareesuwan, Sornchai
    Miller, Robert Scott
    Fukuda, Mark
    Jongsakul, Krisada
    Sriwichai, Sabaithip
    Rowan, Jacqueline
    Bhattacharyya, Helen
    Ohrt, Colin
    Knirsch, Charles
    CLINICAL INFECTIOUS DISEASES, 2006, 43 (10) : 1264 - 1271
  • [22] Efficacy and tolerability of racecadotril in the treatment of cholera in adults: a double blind, randomised, controlled clinical trial
    Alam, NH
    Ashraf, H
    Khan, WA
    Karim, MM
    Fuchs, GJ
    GUT, 2003, 52 (10) : 1419 - 1423
  • [23] A PHASE II, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EXPLORING PHARMACOKINETICS, SAFETY AND EFFICACY OF INTRAVENOUS FACTOR XIII TREATMENT IN ADULTS WITH SYSTEMIC SCLEROSIS
    Leslie, Anna
    Vigneswaran, Shivanee
    Khan, Kiran
    Ong, Voon
    Denton, Christopher P.
    RHEUMATOLOGY, 2024, 63
  • [24] A phase II, randomised, double-blind, placebo-controlled trial exploring pharmacokinetics, safety and efficacy of intravenous factor XIII treatment in adults with systemic sclerosis
    Leslie, Anna
    Vigneswaran, Shivanee
    Khan, Kiran
    Ong, Voon
    Denton, Christopher P.
    RHEUMATOLOGY, 2024, 63
  • [25] Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate dispersible tablets in paediatric patients with acute uncomplicated Plasmodium falciparum malaria: a phase II, multicentric, open-label study
    Offianan Andre Toure
    Stephen Rulisa
    Anupkumar R. Anvikar
    Ballamudi S. Rao
    Pitabas Mishra
    Rajinder K. Jalali
    Sudershan Arora
    Arjun Roy
    Nilanjan Saha
    Sunil S. Iyer
    Pradeep Sharma
    Neena Valecha
    Malaria Journal, 14
  • [26] Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate dispersible tablets in paediatric patients with acute uncomplicated Plasmodium falciparum malaria: a phase II, multicentric, open-label study
    Toure, Offianan Andre
    Rulisa, Stephen
    Anvikar, Anupkumar R.
    Rao, Ballamudi S.
    Mishra, Pitabas
    Jalali, Rajinder K.
    Arora, Sudershan
    Roy, Arjun
    Saha, Nilanjan
    Iyer, Sunil S.
    Sharma, Pradeep
    Valecha, Neena
    MALARIA JOURNAL, 2015, 14
  • [27] Ferroquine and artesunate in African adults and children with Plasmodium falciparum malaria: a phase 2, multicentre, randomised, double-blind, dose-ranging, non-inferiority study
    Held, Jana
    Supan, Christian
    Salazar, Carmen L. O.
    Tinto, Halidou
    Bonkian, Lea N.
    Nahum, Alain
    Moulero, Bancole
    Sie, Ali
    Coulibaly, Boubacar
    Sirima, Sodiomon B.
    Siribie, Mohamadou
    Otsyula, Nekoye
    Otieno, Lucas
    Abdallah, Ahmed M.
    Kimutai, Robert
    Bouyou-Akotet, Marielle
    Kombila, Maryvonne
    Koiwai, Kimiko
    Cantalloube, Cathy
    Din-Bell, Chantal
    Djeriou, Elhadj
    Waitumbi, John
    Mordmueller, Benjamin
    Ter-Minassian, Daniel
    Lell, Bertrand
    Kremsner, Peter G.
    LANCET INFECTIOUS DISEASES, 2015, 15 (12): : 1409 - 1419
  • [28] A randomized, double-blind study on the efficacy and safety of a practical three-day regimen with artesunate and mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in Africa
    Massougbodji, A
    Kinde-Gazard, D
    Same-Ekobo, A
    Cambon, N
    Mueller, EA
    TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, 2002, 96 (06) : 655 - 659
  • [29] A PHASE II/III DOUBLE-BLIND, DOSE-FINDING CLINICAL-TRIAL OF A COMBINATION OF MEFLOQUINE, SULFADOXINE, AND PYRIMETHAMINE (FANSIMEF) IN FALCIPARUM-MALARIA
    DESOUZA, JM
    SHETH, UK
    WERNSDORFER, WH
    TRIGG, PI
    DOBERSTYN, EB
    BULLETIN OF THE WORLD HEALTH ORGANIZATION, 1987, 65 (03) : 357 - 361
  • [30] CHLORPROGUANIL-DAPSONE-ARTESU NATE VS. ARTEMETHER-LUMEFANTRINE: A RANDOMISED, DOUBLE-BLIND PHASE III TRIAL FOR THE TREATMENT OF ACUTE, UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA IN AFRICAN CHILDREN AND ADOLESCENTS
    Premji, Zul
    Umeh, Rich E.
    Owusu-Agyei, Seth
    Esamai, Fabian
    Ezedinachi, Emmanuel
    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.
    AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE, 2008, 79 (06): : 225 - 225