Efficacy and safety of re-treatment with the same artemisinin-based combination treatment (ACT) compared with an alternative ACT and quinine plus clindamycin after failure of first-line recommended ACT (QUINACT): a bicentre, open-label, phase 3, randomised controlled trial

The Lancet Global Health

Volumn 5, Issue 1, 2017, Pages e60-e68

  Mavoko, Hypolite Muhindo ^a,b   Nabasumba, Carolyn ^b,c,d   da Luz, Raquel Inocêncio ^b   Tinto, Halidou ^e   D'Alessandro, Umberto ^f,g,h   Kambugu, Andrew ^c   Baraka, Vito ^b,i   Rosanas Urgell, Anna ^f   Lutumba, Pascal ^a   Van geertruyden, Jean Pierre ^b  

^a cliniques universitaires de Kinshasa   (Democratic Republic Congo)

^b UNIVERSITY OF ANTWERP   (Belgium)

^c MAKERERE UNIVERSITY   (Uganda)

^d MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Uganda)

^e Institut de Recherche en Sciences de la Santé   (Burkina Faso)

^f INSTITUTE OF TROPICAL MEDICINE   (Belgium)

^g LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^h MEDICAL RESEARCH COUNCIL LABORATORIES   (Gambia)

ⁱ NATIONAL INSTITUTE FOR MEDICAL RESEARCH   (Tanzania)

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE; ARTEMETHER; ARTEMISININ; ARTESUNATE; BENFLUMETOL; CLINDAMYCIN; MEROZOITE SURFACE PROTEIN 1; MEROZOITE SURFACE PROTEIN 2; QUINIDINE GLUCONATE; QUININE; AMODIAQUINE, ARTESUNATE DRUG COMBINATION; ANTIMALARIAL AGENT; ARTEMETHER PLUS BENFLUMETOL; ARTEMISININ DERIVATIVE; ETHANOLAMINE DERIVATIVE; FLUORENE DERIVATIVE;

ABNORMAL BEHAVIOR; ANOREXIA; ARTICLE; ASTHENIA; CHILD; CONTROLLED STUDY; COUGHING; DIARRHEA; FOLLOW UP; GENE AMPLIFICATION; GENOTYPE; HUMAN; MAJOR CLINICAL STUDY; MALARIA; MALE; OUTCOME ASSESSMENT; PARASITEMIA; PHASE 3 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; POLYMERASE CHAIN REACTION; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RETREATMENT; CLINICAL TRIAL; DEMOCRATIC REPUBLIC CONGO; DRUG COMBINATION; FEMALE; INFANT; MALARIA FALCIPARUM; TREATMENT OUTCOME; UGANDA;

AMODIAQUINE; ANOREXIA; ANTIMALARIALS; ARTEMISININS; CHILD, PRESCHOOL; CLINDAMYCIN; DEMOCRATIC REPUBLIC OF THE CONGO; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; INFANT; MALARIA, FALCIPARUM; MALE; QUININE; TREATMENT OUTCOME; UGANDA;

EID: 85004065474     PISSN: None     EISSN: 2214109X     Source Type: Journal    
DOI: 10.1016/S2214-109X(16)30236-4     Document Type: Article

References (27)

1. 1 WHO. World malaria report 2015, 2015, World Health Organization, Geneva http://www.who.int/malaria/media/world-malaria-report-2015/en/ (accessed May 27, 2016).
2. 2 WHO. Guidelines for the treatment of malaria, 2006, World Health Organization, Geneva.
3. 3 Wembonyama, S, Mpaka, S, Tshilolo, L, Medicine and health in the Democratic Republic of Congo: from independence to the third republic. Med Trop 67 (2007), 447–457 (in French).
4. 4 Yeka, A, Lameyre, V, Afizi, K, et al. Efficacy and safety of fixed-dose artesunate-amodiaquine vs artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children. PLoS One, 9, 2014, e113311.
5. 5 Achan, J, Tibenderana, JK, Kyabayinze, D, et al. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ, 339, 2009, b2763.
6. 6 Kofoed, PE, Mapaba, E, Lopes, F, Pussick, F, Aaby, P, Rombo, L, Comparison of 3, 5 and 7 days' treatment with Quinimax for falciparum malaria in Guinea-Bissau. Trans R Soc Trop Med Hyg 91 (1997), 462–464.
7. 7 Yeka, A, Achan, J, D'Alessandro, U, Talisuna, AO, Quinine monotherapy for treating uncomplicated malaria in the era of artemisinin-based combination therapy: an appropriate public health policy?. Lancet Infect Dis 9 (2009), 448–452.
8. 8 Fungladda, W, Honrado, ER, Thimasarn, K, et al. Compliance with artesunate and quinine + tetracycline treatment of uncomplicated falciparum malaria in Thailand. Bull World Health Organ 76:suppl 1 (1998), 59–66.
9. 9 Zwang, J, Olliaro, P, Barennes, H, et al. Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis. Malar J, 8, 2009, 203.
10. 10 Tshefu, AK, Gaye, O, Kayentao, K, 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 375 (2010), 1457–1467.
11. 11 Yeka, A, Tibenderana, J, Achan, J, D'Alessandro, U, Talisuna, AO, Efficacy of quinine, artemether-lumefantrine and dihydroartemisinin-piperaquine as rescue treatment for uncomplicated malaria in Ugandan children. PLoS One, 8, 2013, e53772.
12. 12 Muhindo Mavoko, H, Kalabuanga, M, Delgado-Ratto, C, et al. Uncomplicated clinical malaria features, the efficacy of artesunate-amodiaquine and their relation with multiplicity of infection in the Democratic Republic of Congo. PLoS One, 11, 2016, e0157074.
13. 13 Snounou, G, Beck, HP, The use of PCR genotyping in the assessment of recrudescence or reinfection after antimalarial drug treatment. Parasitol Today 14 (1998), 462–467.
14. 14 WHO. Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations: informal consultation organized by the Medicines for Malaria Venture, 2007, World Health Organization, Amsterdam.
15. 15 WHO. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria, 2003, World Health Organization, Geneva.
16. 16 WHO. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity, 2004, World Health Organization, Geneva.
17. 17 Flegg, JA, Guerin, PJ, White, NJ, Stepniewska, K, Standardizing the measurement of parasite clearance in falciparum malaria: the parasite clearance estimator. Malar J, 10, 2011, 339.
18. 18 WHO. Guidelines for the treatment of malaria, 3rd edn., 2015, World Health Organization, Geneva.
19. 19 Lell, B, Kremsner, PG, Clindamycin as an antimalarial drug: review of clinical trials. Antimicrob Agents Chemother 46 (2002), 2315–2320.
20. 20 Obonyo, CO, Juma, EA, Clindamycin plus quinine for treating uncomplicated falciparum malaria: a systematic review and meta-analysis. Malar J, 11, 2012, 2.
21. 21 WWARN Parasite Clearance Study Group. Baseline data of parasite clearance in patients with falciparum malaria treated with an artemisinin derivative: an individual patient data meta-analysis. Malar J, 14, 2015, 359.
22. 22 Ménard, D, Khim, N, Beghain, J, et al. A worldwide map of Plasmodium falciparum K13-propeller polymorphisms. N Engl J Med 374 (2016), 2453–2464.
23. 23 Sagara, I, Fofana, B, Gaudart, J, et al. Repeated artemisinin-based combination therapies in a malaria hyperendemic area of Mali: efficacy, safety, and public health impact. Am J Trop Med Hyg 87 (2012), 50–56.
24. 24 Shayo, A, Buza, J, Ishengoma, DS, Monitoring of efficacy and safety of artemisinin-based anti-malarials for treatment of uncomplicated malaria: a review of evidence of implementation of anti-malarial therapeutic efficacy trials in Tanzania. Malar J, 14, 2015, 135.
25. 25 Yavo, W, Konaté, A, Kassi, FK, et al. Efficacy and safety of artesunate-amodiaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites across Cote d'Ivoire. Malar Res Treat, 2015, 2015, 878132.
26. 26 Onyamboko, MA, Fanello, CI, Wongsaen, K, et al. Randomized comparison of the efficacies and tolerabilities of three artemisinin-based combination treatments for children with acute Plasmodium falciparum malaria in the Democratic Republic of the Congo. Antimicrob Agents Chemother 58 (2014), 5528–5536.
27. 27 Beshir, KB, Sutherland, CJ, Sawa, P, et al. Residual Plasmodium falciparum parasitemia in Kenyan children after artemisinin-combination therapy is associated with increased transmission to mosquitoes and parasite recurrence. J Infect Dis 208 (2013), 2017–2024.