Adding a single low-dose of primaquine (0.25 mg/kg) to artemether-lumefantrine did not compromise treatment outcome of uncomplicated Plasmodium falciparum malaria in Tanzania: A randomized, single-blinded clinical trial

Malaria Journal

Volumn 15, Issue 1, 2016, Pages

  Mwaiswelo, Richard ^a   Ngasala, Billy ^a   Jovel, Irina ^b   Aydin Schmidt, Berit ^b   Gosling, Roland ^c,d   Premji, Zul ^e   Mmbando, Bruno ^f   Björkman, Anders ^b   Mårtensson, Andreas ^g  

^a MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES   (Tanzania)

^b KAROLINSKA INSTITUTE   (Sweden)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e AGA KHAN UNIVERSITY   (Kenya)

^f NATIONAL INSTITUTE FOR MEDICAL RESEARCH   (Tanzania)

^g UPPSALA UNIVERSITY   (Sweden)

Author keywords

Artemether lumefantrine; Cure rate; Plasmodium falciparum malaria; Primaquine

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; PRIMAQUINE; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; DRUG COMBINATION; ETHANOLAMINE DERIVATIVE; FLUORENE DERIVATIVE; PROTOZOAL DNA;

ARTICLE; CONTROLLED STUDY; DISEASE TRANSMISSION; DRUG SAFETY; FEMALE; FEVER; FOLLOW UP; HUMAN; INFANT; INFECTION RATE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; PARASITE CLEARANCE; PATIENT MONITORING; POLYMERASE CHAIN REACTION; RANDOMIZED CONTROLLED TRIAL; RECURRENT INFECTION; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; TANZANIA; TREATMENT OUTCOME; TREATMENT RESPONSE; ADOLESCENT; CHILD; DRUG COMBINATION; GENETICS; ISOLATION AND PURIFICATION; MALARIA, FALCIPARUM; PARASITEMIA; PARASITOLOGY; PLASMODIUM FALCIPARUM; PREGNANCY; PRESCHOOL CHILD; YOUNG ADULT;

ADOLESCENT; ANTIMALARIALS; ARTEMISININS; CHILD; CHILD, PRESCHOOL; DNA, PROTOZOAN; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; INFANT; MALARIA, FALCIPARUM; MALE; PARASITEMIA; PLASMODIUM FALCIPARUM; POLYMERASE CHAIN REACTION; PREGNANCY; PRIMAQUINE; SINGLE-BLIND METHOD; TANZANIA; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84983638224     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/s12936-016-1430-3     Document Type: Article

References (27)

1. WHO. World Malaria Report 2010. Geneva, World Health Organization, 2010.
2. WHO. Evidence Review Group: The safety and effectiveness of single dose primaquine as a P. falciparum gametocytocide. Geneva, World Health Organization, 2012.
3. WHO. Guidelines for the treatment of malaria. 3rd ed. Geneva, World Health Organization, 2015.
4. Barnes KI, Lindegardh N, Ogundahunsi O, Olliaro P, Plowe CV, Randrianarivelojosia M, et al. World Antimalarial Resistance Network (WARN) IV: clinical pharmacology. Malar J. 2007;6:122.
5. Dooley KE, Flexner C, Andrade AS. Drug interactions involving combination antiretroviral therapy and other anti-infective agents: repercussions for resource-limited countries. J Infect Dis. 2008;198:1-14.
6. Eziefula AC, Gosling R, Hwang J, Hsiang MS, Bousema T, von Seidlein L, et al. Rationale for short course primaquine in Africa to interrupt malaria transmission. Malar J. 2012;11:360.
7. Mnzava AEP, Kilama WL. Observations on the ecological distribution of Anopheles gambiae complex in Tanzania. Acta Trop. 1986;43:277-82.
8. Temu EA, Minjas JN, Coetzee M, Hunt RH, Shiff CJ. The role of four anopheline species (Diptera: Culicidae) in malaria transmission in coastal Tanzania. Trans R Soc Trop Med Hyg. 1998;92:152-8.
9. Kabula B, Derua Y, Tungu P, Massue DJ, Sambu E, Stanley G, et al. Malaria entomological profile in Tanzania from 1950 to 2010: A review of mosquito distribution, vectorial capacity and insecticide resistance. Tanzan J Health Res. 2011;13:1-14.
10. NMCP. National malaria stratergic plan 2014-2020. National Malaria Control Prograamme. Ministry of Health and Social Welfare. The United Republic of Tanzania. http://ihi.eprints.org/3314/1/Malaria-Strategic-Plan-Full-Version-02-27-14.pdf (2014). Accessed 20 Feb 2016.
11. Mwaiswelo R, Ngasala BE, Jovel I, Gosling R, Premji Z, Poirot E, et al. Safety of a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania. Malar J. 2016;15:316.
12. WHO. Methods for surveillance of antimalarial drug efficacy. Geneva, World Health Organization, 2009.
13. Urbaniak GC, Plous S. Research Randomizer (version 4.0) (Computer software). http://www.randomizer.org/ (2013). Accessed 22 June 2013.
14. NMCP. Tanzania Malaria Programme Review 2010. Programme Review Proposal. National Malaria Control Programme. Ministry of Health and Social Welfare. Dar es Salaam, Tanzania. http://www.rollbackmalaria.org/files/files/countries/Tanzania-The-malaria-program-performance-review-2010.pdf. Accessed 12 Jan 2016.
15. Eziefula AC, Bousema T, Yeung S, Kamya M, Owaraganise A, Gabagaya G, et al. Single dose primaquine for clearance of Plasmodium falciparum gametocytes in children with uncomplicated malaria in Uganda: a randomised, controlled, double-blind, dose-ranging trial. Lancet Infect Dis. 2014;14:130-9.
16. Hsiang MS, Lin M, Dokomajilar C, Kemere J, Pilcher CD, Dorsey G, Greenhouse B. PCR-based pooling of dried blood spots for detection of malaria parasites: optimization and application to a cohort. J Clin Microbiol. 2010;48:3539-43.
17. Snounou G, Zhu X, Siripoon N, Jarra W, Thaithong S, Brown K, et al. Biased distribution of mspl populations in Thailand and msp2 allelic variants in Plasmodium falciparum. Trans R Soc Trop Med Hyg. 1999;2:369-74.
18. Djimdé A, Doumba O, Cortese J, Kayentao K, Doumbo S, Diourte Y, et al. A molecular marker for chloroquine-resistant falciparum malaria. N Engl J Med. 2001;344:257-63.
19. Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, et al. Efficacy and effectiveness of artemether-lumefantrine after initial and repeated treatment in children <5 years of age with acute uncomplicated Plasmodium falciparum malaria in rural Tanzania: a randomized trial. Clin Infect Dis. 2011;52:873-82.
20. Kamugisha E, Jing S, Minde M, Kataraihya J, Kongola G, Kironde F, et al. Efficacy of artemether-lumefantrine in treatment of malaria among under-fives and prevalence of drug resistance markers in Igombe-Mwanza. Malar J. 2012;11:58.
21. Shayo A, Mandara CI, Shahada F, Buza J, Lemnge MM, Ishengoma DS. Therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in North-Eastern Tanzania. Malar J. 2014;13:376.
22. Shekalaghe S, Drakeley C, Gosling R, Ndaro A, van Meegeren M, Enevold A, et al. Primaquine clears submicroscopic Plasmodium falciparum gametocytes that persist after treatment with sulphadoxine-pyrimethamine and artesunate. PLoS One. 2007;2:1023.
23. Malmberg M, Ferreira PE, Tarning J, Ursing J, Ngasala B, Björkman A, et al. Plasmodium falciparum drug resistance phenotype as assessed by patient antimalarial drug levels and its association with pfmdr1 polymorphisms. J Infect Dis. 2013;207:842-7.
24. Sisowath C, Stromberg J, Martensson A, Msellem M, Obondo C, Bjorkman A, et al. In vivo selection of Plasmodium falciparum pfmdr1 86 N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005;191:1-4.
25. Sisowath C, Petersen I, Veiga MI, Mårtensson A, Premji Z, Björkman A, et al. In vivo selection of Plasmodium falciparum parasites carrying the chloroquine-susceptible pfcrt K76 allele after treatment with artemether-lumefantrine in Africa. J Infect Dis. 2009;199:750-7.
26. Henriques G, Hallett RL, Beshir KB, Gadalla NB, Johnson RE, Burrow R, et al. Directional selection at the pfmdr1, pfcrt, pfubp1, and pfap2mu loci of Plasmodium falciparum in Kenyan children treated with ACT. J Infect Dis. 2014;210:2001-8.
27. Malmberg M, Ngasala B, Ferreira PE, Larsson E, Jovel I, Hjalmarsson A, et al. Temporal trends of molecular markers associated with artemether-lumefantrine tolerance/resistance in Bagamoyo district, Tanzania. Malar J. 2013;12:103.