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

Malaria Journal

Volumn 14, Issue 1, 2015, Pages

  Toure, Offianan Andre ^a   Rulisa, Stephen ^b   Anvikar, Anupkumar R ^c   Rao, Ballamudi S ^d   Mishra, Pitabas ^e   Jalali, Rajinder K ^f   Arora, Sudershan ^f   Roy, Arjun ^f   Saha, Nilanjan ^f   Iyer, Sunil S ^f   Sharma, Pradeep ^f   Valecha, Neena ^c  

^a INSTITUT PASTEUR DE CÔTE D'IVOIRE   (Côte d’Ivoire)

^b UNIVERSITY OF RWANDA   (Rwanda)

^c NATIONAL INSTITUTE OF MALARIA RESEARCH   (India)

^d Manipal Tata Medical College Jamshedpur   (India)

^e ISPAT GENERAL HOSPITAL   (India)

^f RANBAXY LABORATORIES LTD   (India)

Author keywords

Artemisinin combination therapy; Arterolane maleate; FCT; Fixed dose combination; Malaria; Paediatric; PCR corrected ACPR; PCT; Piperaquine phosphate

Indexed keywords

ANTIMALARIAL AGENT; ARTEROLANE MALEATE PLUS PIPERAQUINE PHOSPHATE; UNCLASSIFIED DRUG; ARTEROLANE; DRUG COMBINATION; PEROXIDE; PIPERAQUINE; QUINOLINE DERIVATIVE; SINGLE HETEROCYCLIC RINGS; SPIRO COMPOUND; TABLET;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CHICKENPOX; CHILD; COUGHING; DECREASED APPETITE; DIARRHEA; DISEASE DURATION; DISEASE SEVERITY; DISPERSIBLE TABLET; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG SAFETY; ECG ABNORMALITY; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HYPERHIDROSIS; INFANT; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OTITIS MEDIA; PARASITE CLEARANCE; PHASE 2 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; QT PROLONGATION; RHINITIS; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VOMITING; CLINICAL TRIAL; COTE D'IVOIRE; DRUG COMBINATION; DRUG EFFECTS; INDIA; MALARIA; MALARIA, FALCIPARUM; NEWBORN; PHASE 3 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRESCHOOL CHILD; RWANDA; TABLET;

ANTIMALARIALS; CHILD; CHILD, PRESCHOOL; COTE D'IVOIRE; DRUG COMBINATIONS; FEMALE; HETEROCYCLIC COMPOUNDS, 1-RING; HUMANS; INDIA; INFANT; INFANT, NEWBORN; MALARIA; MALARIA, FALCIPARUM; MALE; PEROXIDES; PLASMODIUM FALCIPARUM; QUINOLINES; RWANDA; SPIRO COMPOUNDS; TABLETS;

EID: 84947905708     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/s12936-015-0982-y     Document Type: Article

References (35)

1. WHO. World Malaria Report. Geneva, World Health Organization. 2014. http://www.who.int/malaria/publications/world-malaria-report-2014/en/.
2. WHO. Guidelines for treatment of malaria, 2nd edn. 2010. http://whqlibdoc.who.int/publications/2010/9789241547925-eng.pdf.
3. WHO. Global report on antimalarial drug efficacy and drug resistance. World Health Organization, Geneva. 2000-2010.
4. Davis TM, Hung TY, Sim IK, Karunajeewa HA, Ilett KF. Piperaquine: a resurgent antimalarial drug. Drugs. 2005;65:75-87.
5. Valecha N, Looareesuwan S, Martensson A, Abdulla SM, Krudsood S, Tangpukdee N, et al. Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria: a phase ii, multicenter, randomized, dose-finding clinical trial. CID. 2010;51:684-91.
6. Van Noorden Richard. Farmers and scientists struggle to keep up the needs of ambitious medicine-subsidy programme. Nature. 2010;466:672-3.
7. Achan J, Adam I, Arinaitwe E, Ashley EA, Awab GR, Ba MS, et al. The effect of dosing regimens on the antimalarial efficacy of dihydroartemisinin-piperaquine: a pooled analysis of individual patient data. PLoS Med. 2013;10:e1001564.
8. O'Neill PM, Barton VE, Ward SA, Chadwick J. 4-Aminoquinolines: chloroquine, amodiaquine and next-generation analogues. In: Staines HM, Krishna S, editors. Milestones in drug therapy. Treatment and prevention of malaria. Basel: Springer; 2012. pp. 19-44.
9. Saha N, Moehrle JJ, Zutshi A, Sharma P, Kaur P, Iyer SS. Safety, tolerability and pharmacokinetic profile of single and multiple oral doses of arterolane (RBx11160) maleate in healthy subjects. J Clin Pharmacol. 2014;54(4):386-93.
10. Valecha N, Krudsood S, Tangpukdee N, Mohanty S, Sharma SK, Tyagi PK, et al. Arterolane maleate plus piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: a comparative, multicenter, randomized clinical trial. Clin Infect Dis. 2012;55:663-71.
11. Yeka A, Harris JC. Treating uncomplicated malaria in children: comparing artemisinin-based combination therapies. Curr Opin Pediatr. 2010;22:798-803.
12. Guidance for Industry. Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM). 2001.
13. WHO. Methods of surveillance of antimalarial drug efficacy. Geneva, World Health Organization. 2009. http://whqlibdoc.who.int/publications/2009/9789241597531-eng.pdf.
14. Tshefu AK, Gaye O, Kayentao K, Thompson R, Bhatt KM, Sesay SS, et al. 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. Lancet. 2010;375:1457-67.
15. Kabanywanyi AM, Mwita A, Sumari D, Mandike R, Mugittu K, Abdulla S. Efficacy and safety of artemisinin-based antimalarial in the treatment of uncomplicated malaria in children in southern Tanzani. Malar J. 2007;6:146.
16. Djallé D, Njuimo SP, Manirakiza A, Laganier R, Le Faou A, Rogier C. Efficacy and safety of artemether + lumefantrine, artesunate + sulphamethoxypyrazine-pyrimethamine and artesunate + amodiaquine and sulphadoxine-pyrimethamine + amodiaquine in the treatment of uncomplicated falciparum malaria in Bangui, Central African Republic: a randomized trial. Malar J. 2014;13:9.
17. Mårtensson A, Strömberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, et al. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005;41:1079-86.
18. Four Artemisinin-Based Combinations. (4ABC) Study Group: a head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial. PLoS Med. 2011;8:e1001119.
19. Ndounga M, Mayengue PI, Casimiro PN, Loumouamou D, Basco LK, Ntoumi F, et al. Artesunate-amodiaquine efficacy in Congolese children with acute uncomplicated falciparum malaria in Brazzaville. Malar J. 2013;12:53.
20. Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R, Pinoges L, et al. Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia. Malar J. 2013;12:250.
21. Sylla K, Abiola A, Tine RC, Faye B, Sow D, Ndiaye JL, et al. Monitoring the efficacy and safety of three artemisinin based-combinations therapies in Senegal: results from two years surveillance. BMC Infect Dis. 2013;13:598.
22. Global Plan For artemisinin resistance Containment (GPARC). 2014. http://www.who.int/malaria/publications/atoz/artemisinin-resistance-containment-2011.pdf?ua=1. Accessed 14 March 2014.
23. Uhlemann AC, Wittlin S, Matile H, Bustamante LY, Krishna S. Mechanism of antimalarial action of the synthetic trioxolane RBX11160 (OZ277). Antimicrob Agents Chemother. 2007;51:667-72.
24. Price RN, Hasugian AR, Ratcliff A, Siswantoro H, Purba HL, Kenangalem E, et al. Clinical and pharmacological determinants of the therapeutic response to dihydroartemisinin-piperaquine for drug-resistant malaria. Antimicrob Agents Chemother. 2007;51:4090-97.
25. Tarning J, Zongo I, Somé FA, Rouamba N, Parikh S, Rosenthal PJ, et al. Population pharmacokinetics and pharmacodynamics of piperaquine in children with uncomplicated falciparum malaria. Clin Pharmacol Ther. 2012;91:497-505.
26. Hung TY, Davis TM, Ilett KF, Karunajeewa H, Hewitt S, Denis MB, et al. Population pharmacokinetics of piperaquine in adults and children with uncomplicated falciparum or vivax malaria. Br J Clin Pharmacol. 2003;57:253-62.
27. Gargano N, Cenci F, Bassat Q. Antimalarial efficacy of piperaquine-based Antimalarial combination therapies: facts and uncertainties. Trop Med Int Health. 2011;16:1466-73.
28. UK Summary of Product characteristics of Riamet 20/120 mg tablet (20 mg artemether and 120 mg lumefantrine). Novartis Pharmaceuticals UK Ltd. 2013.
29. Mytton OT, Ashley EA, Peto L, Price RN, La Y, Hae R, et al. Electrocardiographic safety evaluation of dihydroartemisinin-piperaquine in the treatment of uncomplicated falciparum malaria. Am J Trop Med Hyg. 2007;77:447-50.
30. Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart. 2003;89:1363-72.
31. Erhart LM, Yingyuen K, Chuanak N, Buathong N, Laoboonchai A, Miller RS, et al. Hematologic and clinical indices of malaria in a semi-immune population of western Thailand. Am J Trop Med Hyg. 2004;70:8-14.
32. Kurtzhals JA, Reimert CM, Tette E, Dunyo SK, Koram KA, Akanmori BD, et al. Increased eosinophil activity in acute Plasmodium falciparum infection - association with cerebral malaria. Clin Exp Immunol. 1998;112:303-7.
33. Halim NK, Ajayi OI, Oluwafemi F. Monocytosis in acute malaria infection. Niger J Clin Pract. 2002;5:106-8.
34. Olliaro P, Djimdé A, Dorsey G, Karema C, Mårtensson A, Ndiaye JL, et al. Hematological parameters in paediatric uncomplicated plasmodium falciparum malaria in sub-Saharan Africa. Am J Trop Med Hyg. 2011;85:619-25.
35. Thanachartwet V, Krudsood S, Tangpukdee N, Phumratanaprapin W, Silachamroon U, Leowattana W, et al. Hyponatraemia and hypokalaemia in adults with uncomplicated malaria in Thailand. Trop Doct. 2008;38:155-7.