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Tolerability and Efficacy of a Pediatric Granule Formulation of Artesunate-Mefloquine in Young Children from Cameroon with Uncomplicated Falciparum Malaria
Félix Tietche
Félix Tietche
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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David Chelo
David Chelo
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Njiki Kinkela Mina Ntoto
Njiki Kinkela Mina Ntoto
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Florence Minjiwa Djoukoue
Florence Minjiwa Djoukoue
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Christoph Hatz
Christoph Hatz
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Sarabel Frey
Sarabel Frey
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Adrian Frentzel
Adrian Frentzel
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Sonja Trapp
Sonja Trapp
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Roland Zielonka
Roland Zielonka
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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Edgar A. Mueller
Edgar A. Mueller
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon; Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon; Swiss Tropical Institute, Basel, Switzerland; University Children's Hospital Basel, Switzerland; Mepha Ltd, Aesch, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany
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A fixed-dose pediatric formulation of artesunate and mefloquine (Artequin Pediatric) has been developed. In this open, non-comparative study in Cameroonian children with uncomplicated falciparum malaria, the safety and efficacy of this formulation was tested, with a particular emphasis on the risk of neuropsychiatric adverse events (AEs). In total, 220 subjects, weighing between 10 and 20 kg, were enrolled; 213 qualified for analysis. Artesunate-mefloquine was given once daily for 3 days. Overall, 13.1% of patients reported mild to moderate neuropsychiatric AEs (elicited through a structured questionnaire or reported spontaneously) out of which 3.8% (mainly insomnia) were considered drug-related. Other drug-related AEs were infrequent (< 3%). Polymerase chain reaction-corrected cure rate (adequate clinical and parasitological response) determined by survival analysis at 28 and 63 days was 96.6%. New infections were observed in 11.2% of evaluable patients at 63 days. The new formulation was well tolerated and efficacious in the population investigated.
Author Notes
Financial support: This study was supported by Mepha Ltd, Aesch, Switzerland.
Disclosure: Adrian Frentzel and Sonja Trapp are employees of Mepha Ltd. This statement is made in the interest of full disclosure and not because the authors consider this a conflict of interest.
Authors' addresses: David Chelo, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon, and Centre Mère et Enfant, Fondation Chantal Biya, Cameroon, E-mail: chelodad6@yahoo.fr. Njiki Kinkela Mina Ntoto and Florence Minjiwa Djoukoue, Centre Mère et Enfant, Fondation Chantal Biya, Yaoundé, Cameroon, E-mails: mnjikin@yahoo.fr and minjiflo@yahoo.fr. Christoph Hatz, Swiss Tropical Institute, Basel, Switzerland, E-mail: Christoph.Hatz@unibas.ch. Sarabel Frey, University Children's Hospital, Basel, Switzerland, E-mail: Sarabel.Frey@ukbb.ch. Adrian Frentzel and Sonja Trapp, Mepha Ltd., Aesch, Switzerland, E-mails: Adrian.Frentzel@mepha.ch and Sonja.Trapp@mepha.ch. Roland Zielonka and Edgar A. Mueller, Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Dresden, Germany, E-mails: Roland.Zielonka@googlemail.com and Edgar.Mueller@tu-dresden.de.
Reprint requests: Edgar A. Mueller, Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Fiedlerstrasse 27, D-01307 Dresden, Germany, E-mail: Edgar.Mueller@tu-dresden.de.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Wongsrichanalai C, Pickard AL, Wernsdorfer WH, Meshnick SR, 2002. Epidemiology of drug-resistant malaria. Lancet Infect Dis 2: 209–218.
-
2.
Snow RW, Guerra CA, Noor AM, Myint HY, Hay SI, 2005. The global distribution of clinical episodes of Plasmodium falciparum malaria. Nature 434: 214–217.
-
3.
Greenwood BM, Bojang K, Whitty CJ, Targett GA, 2005. Malaria. Lancet 365: 1487–1498.
-
4.
Nosten F, White NJ, 2007. Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 77 (Suppl 6): 181–192.
-
5.
World Health Organization, 2006. Guidelines for the treatment of malaria. Available at: http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Accessed September 29, 2009.
-
6.
Mutabingwa TK, 2005. Artemisinin-based combination therapies (ACTs): best hope for malaria treatment but inaccessible to the needy! Acta Trop 95: 305–315.
-
7.
Ashley EA, White NJ, 2005. Artemisinin-based combinations. Curr Opin Infect Dis 18: 531–536.
-
8.
Duffy PE, Mutabingwa TK, 2006. Artemisinin combination therapies. Lancet 367: 2037–2039.
-
9.
World Health Organization, 2008. Global AMDP database – AFRO. Available at: http://apps.who.int/malaria/amdp/amdp_afro.htm. Accessed September 29, 2009.
-
10.
Sinclair D, Zani B, Donegan S, Olliaro P, Garner P, 2009. Artemisinin-based combination therapy for treating uncomplicated malaria. Cochrane Database Syst Rev 3: CD007483.
-
11.
Krudsood S, Looareesuwan S, Silachamroon U, Chalermrut K, Pittrow D, Cambon N, Mueller EA, 2002. Artesunate and mefloquine given simultaneously for three days via a prepacked blister is equally effective and tolerated as a standard sequential treatment of uncomplicated acute Plasmodium falciparum malaria: randomized, double-blind study in Thailand. Am J Trop Med Hyg 67: 465–472.
-
12.
Massougbodji A, Kone M, Kinde-Gazard D, Same-Ekobo A, Cambon N, Mueller EA, 2002. 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. Trans R Soc Trop Med Hyg 96: 655–659.
-
13.
Bhatt KM, Samia BM, Bhatt SM, Wasunna KM, 2006. Efficacy and safety of an artesunate/mefloquine combination, (Artequin) in the treatment of uncomplicated P. falciparum malaria in Kenya. East Afr Med J 83: 236–242.
-
14.
Faye B, Ndiaye JL, Ndiaye D, Dieng Y, Faye O, Gaye O, 2007. Efficacy and tolerability of four antimalarial combinations in the treatment of uncomplicated Plasmodium falciparum malaria in Senegal. Malar J 6: 80.
-
15.
Agomo PU, Meremikwu MM, Watila IM, Omalu IJ, Odey FA, Oguche S, Ezeiru VI, Aina OO, 2008. Efficacy, safety and tolerability of artesunate-mefloquine in the treatment of uncomplicated Plasmodium falciparum malaria in four geographic zones of Nigeria. Malar J 7: 172.
-
16.
Sagara I, Diallo A, Kone M, Coulibaly M, Diawara SI, Guindo O, Maiga H, Niambele MB, Sissoko M, Dicko A, Djimde A, Doumbo OK, 2008. A randomized trial of artesunate-mefloquine versus artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Mali. Am J Trop Med Hyg 79: 655–661.
-
17.
Ramharter M, Kurth FM, Bélard S, Bouyou-Akotet MK, Mamfoumbi MM, Agnandji ST, Missinou MA, Adegnika AA, Issifou S, Cambon N, Heidecker JL, Kombila M, Kremsner PG, 2007. Pharmacokinetics of two paediatric artesunate-mefloquine drug formulations in the treatment of uncomplicated falciparum malaria in Gabon. J Antimicrob Chemother 60: 1091–1096.
-
18.
Kremsner PG, Krishna S, 2004. Antimalarial combinations. Lancet 364: 285–294.
-
19.
Taylor WR, White NJ, 2004. Antimalarial drug toxicity: a review. Drug Saf 27: 25–61.
-
20.
Rønn AM, Rønne-Rasmussen J, Gøtzsche PC, Bygbjerg IC, 1998. Neuropsychiatric manifestations after mefloquine therapy for Plasmodium falciparum malaria: comparing a retrospective and a prospective study. Trop Med Int Health 3: 83–88.
-
21.
Nosten F, van Vugt M, 1999. Neuropsychiatric adverse effects of mefloquine: what do we know and what should we do? CNS Drugs 11: 1–8.
-
22.
Toovey S, 2009. Mefloquine neurotoxicity: a literature review. Travel Med Infect Dis 7: 2–6.
-
23.
Price RN, Nosten F, Luxemburger C, Kham A, Brockman A, Chongsuphajaisiddhi T, White NJ, 1995. Artesunate versus artemether in combination with mefloquine for the treatment of multidrug resistant falciparum malaria. Trans R Soc Trop Med Hyg 89: 523–527.
-
24.
Price RN, Nosten F, Luxemburger C, van Vugt M, Paiphun L, Chongsuphajaisiddhi T, White NJ, 1999. Artesunate-mefloquine treatment of 1967 patients with multi-drug resistant falciparum malaria. Trans R Soc Trop Med Hyg 91: 574–577.
-
25.
Adam I, A-Elbasit IE, Elbashir MI, 2005. Efficacies of mefloquine alone and of artesunate followed by mefloquine, for the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan. Ann Trop Med Parasitol 99: 111–117.
-
26.
Hay SI, Guerra CA, Gething PW, Patil AP, Tatem AJ, Noor AM, Kabaria CW, Manh BH, Elyazar IR, Brooker S, Smith DL, Moyeed RA, Snow RW, 2009. A world malaria map: Plasmodium falciparum endemicity in 2007. PLoS Med 6: e1000048.
-
27.
World Health Organization, 2000. Management of Severe Malaria: A practical handbook. Second edition. Available at: http://www.rollbackmalaria.org/docs/hbsm.pdf. Accessed September 29, 2009.
-
28.
World Health Organization, 2003. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Available at: http://www.who.int/malaria/docs/ProtocolWHO.pdf. Accessed September 29, 2009.
-
29.
Aylward GP, 1997. Conceptual issues in developmental screening and assessment. J Dev Behav Pediatr 18: 340–349.
-
30.
Aylward GP, Verhulst SJ, 2000. Predictive utility of the Bayley Infant Neurodevelopmental Screener (BINS) risk status classifications: clinical interpretation and application. Dev Med Child Neurol 42: 25–31.
-
31.
Largo RH, Caflisch JA, Hug F, Muggli K, Molnar AA, Molinari L, Sheehy A, Gasser ST, 2001. Neuromotor development from 5 to 18 years. Part 1: timed performance. Dev Med Child Neurol 43: 436–443.
-
32.
Largo RH, Caflisch JA, Hug F, Muggli K, Molnar AA, Molinari L, 2001. Neuromotor development from 5 to 18 years. Part 2: associated movements. Dev Med Child Neurol 43: 444–453.
-
33.
World Health Organization, 2007. Recommended genotyping procedures (RGPs) to identify parasite populations. Available at: http://malaria.who.int/docs/drugresistance/RGPText_STI.pdf. Accessed September 29, 2009.
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