Tolerability and efficacy of a pediatric granule formulation of artesunate-mefloquine in young children from Cameroon with uncomplicated falciparum malaria

American Journal of Tropical Medicine and Hygiene

Volumn 82, Issue 6, 2010, Pages 1034-1040

  Tietche, Félix ^g   Chelo, David ^a,b   Mina Ntoto, Njiki Kinkela ^b   Djoukoue, Florence Minjiwa ^b   Hatz, Christoph ^c   Frey, Sarabel ^d   Frentzel, Adrian ^e   Trapp, Sonja ^e   Zielonka, Roland ^f   Mueller, Edgar A ^f  

^a UNIVERSITY OF YAOUNDÉ I   (Cameroon)

^b Mother and Child Centre of The Chantal Biya Foundation Yaounde   (Cameroon)

^c SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE   (Switzerland)

^d UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^e Mepha Ltd   (Switzerland)

^f DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^g NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; ARTESUNATE; ARTESUNATE PLUS MEFLOQUINE; MEFLOQUINE; QUININE;

ANEMIA; ARTICLE; CAMEROON; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; DIARRHEA; DRUG EFFICACY; DRUG FORMULATION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; FEMALE; GRANULE CELL; HUMAN; INFANT; INSOMNIA; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; OBSERVATION; POLYMERASE CHAIN REACTION; PRESCHOOL CHILD; QUESTIONNAIRE; RISK; SCHOOL CHILD; SURVIVAL; VOMITING;

ARTESUNATE;

EID: 77953793203     PISSN: 00029637     EISSN: None     Source Type: Journal    
DOI: 10.4269/ajtmh.2010.09-0704     Document Type: Article

References (46)

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. (Pubitemid 32651788)
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.
34. Falade C, Makanga M, Premji Z, Ortmann CE, Stockmeyer M, de Palacios PI, 2005. Efficacy and safety of artemether-lumefantrine (Coartem) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 99: 459-467.
35. Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA, 2008. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J 7: 246.
36. Karbwang J, White NJ, 1990. Clinical pharmacokinetics of mefloquine. Clin Pharmacokinet 19: 264-279.
37. Luxemburger C, Price RN, Nosten F, Ter Kuile FO, Chongsuphajaisiddhi T, White NJ 1996. Mefloquine in infants and young children. Ann Trop Paediatr 16: 281-286.
38. Ambler MT, Dubowitz LM, Arunjerdja R, Hla EP, Thwai KL, Viladpainguen J, Singhasivanon P, Luxemburger C, Nosten F, McGready R, 2009. The neurological assessment in young children treated with artesunate monotherapy or artesunate-mefloquine combination therapy for uncomplicated Plasmodium falciparum malaria. Malar J 8: 207.
39. Abdulla S, Sagara I, Borrmann S, D'Alessandro U, González R, Hamel M, Ogutu B, Mårtensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP, Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z, 2008. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet 372: 1819-1827.
40. Carrara VI, Phyo AP, Nwee P, Soe M, Htoo H, Arunkamomkiri J, Singhasivanon P, Nosten F, 2008. Auditory assessment of patients with acute uncomplicated Plasmodium falciparum malaria treated with three-day mefloquine-artesunate on the north-western border of Thailand. Malar J 7: 233.
41. Price R, van Vugt M, Phaipun L, Luxemburger C, Simpson J, McGready R, ter Kuile F, Kham A, Chongsuphajaisiddhi T, White NJ, Nosten F, 1999. Adverse effects in patients with acute falciparum malaria treated with artemisinin derivatives. Am J Trop Med Hyg 60: 547-555.
42. van Vugt M, Brockman A, Gemperli B, Luxemburger C, Gathmann I, Royce C, Slight T, Looareesuwan S, White NJ, Nosten F, 1998. Randomized comparison of artemether-benflumetol and artesunate-mefloquine in treatment of multidrug-resistant falciparum malaria. Antimicrob Agents Chemother 42: 135-139.
43. Ashley EA, Lwin KM, McGready R, Simon WH, Phaiphun L, Proux S, Wangseang N, Taylor W, Stepniewska K, Nawamaneerat W, Thwai KL, Barends M, Leowattana W, Olliaro P, Singhasivanon P, White NJ, Nosten F, 2006. An open label randomized comparison of mefloquine-artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. Trop Med Int Health 11: 1653-1660.
44. Okell LC, Drakeley CJ, Bousema T, Whitty CJ, Ghani AC, 2008. Modelling the impact of artemisinin combination therapy and long-acting treatments on malaria transmission intensity. PLoS Med 5: e226.
45. Mutabingwa TK, Anthony D, Heller A, Hallett R, Ahmed J, Drakeley C, Greenwood BM, Whitty CJ, 2005. Amodiaquine alone, amodiaquine+sulfadoxine- pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Lancet 365: 1474-1480.
46. Zongo I, Dorsey G, Rouamba N, Dokomajilar C, Séré Y, Rosenthal PJ, Ouédraogo JB, 2007. Randomized comparison of amodiaquine plus sulfadoxine-pyrimethamine, artemether-lumefantrine, and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso. Clin Infect Dis 45: 1453-1461.