Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial

PLoS Medicine

Volumn 13, Issue 9, 2016, Pages

  Madanitsa, Mwayiwawo ^a,b   Kalilani, Linda ^a   Mwapasa, Victor ^a   van Eijk, Anna M ^b   Khairallah, Carole ^b   Ali, Doreen ^c   Pace, Cheryl ^b   Smedley, James ^b   Thwai, Kyaw Lay ^d   Levitt, Brandt ^e   Wang, Duolao ^b   Kang’ombe, Arthur ^b   Faragher, Brian ^b   Taylor, Steve M ^d,f   Meshnick, Steve ^d   ter Kuile, Feiko O ^b  

^a UNIVERSITY OF MALAWI   (Malawi)

^b LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

^c MINISTRY OF HEALTH   (Malawi)

^d University of North Carolina at Chapel Hill   (United States)

^e DUKE UNIVERSITY MEDICAL CENTER   (United States)

^f DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIHYDROARTEMISININ; HEMOGLOBIN; PIPERAQUINE; PYRIMETHAMINE; SULFADOXINE; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; DRUG COMBINATION; FANASIL, PYRIMETHAMINE DRUG COMBINATION; QUINOLINE DERIVATIVE;

ADULT; ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DIAGNOSTIC TEST; FEMALE; FETUS WASTAGE; HUMAN; MAJOR CLINICAL STUDY; MALARIA; MALAWI; MICROSCOPY; POLYMERASE CHAIN REACTION; PREGNANCY; PREGNANCY OUTCOME; PREVALENCE; RANDOMIZED CONTROLLED TRIAL; ADOLESCENT; DRUG COMBINATION; PREGNANCY COMPLICATIONS, PARASITIC; UTILIZATION; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIMALARIALS; ARTEMISININS; DIAGNOSTIC TESTS, ROUTINE; DRUG COMBINATIONS; FEMALE; HUMANS; MALARIA; MALAWI; PREGNANCY; PREGNANCY COMPLICATIONS, PARASITIC; PYRIMETHAMINE; QUINOLINES; SULFADOXINE; YOUNG ADULT;

EID: 84989821026     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1002124     Document Type: Article

References (37)

1. Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, et al. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis. 2007;7:93–104. doi: 10.1016/S1473-3099(07)70021-X17251080
2. Desai M, Gutman J, Taylor SM, Wiegand RE, Khairallah C, Kayentao K, et al. Impact of sulfadoxine-pyrimethamine resistance on effectiveness of intermittent preventive therapy for malaria in pregnancy at clearing infections and preventing low birth weight. Clin Infect Dis. 2016;62:323–333. doi: 10.1093/cid/civ88126486699
3. Chico RM, Cano J, Ariti C, Collier TJ, Chandramohan D, Roper C, et al. Influence of malaria transmission intensity and the 581G mutation on the efficacy of intermittent preventive treatment in pregnancy: systematic review and meta-analysis. Trop Med Int Health. 2015;20:1621–1633. doi: 10.1111/tmi.1259526325263
4. Harrington WE, Mutabingwa TK, Muehlenbachs A, Sorensen B, Bolla MC, Fried M, et al. Competitive facilitation of drug-resistant Plasmodium falciparum malaria parasites in pregnant women who receive preventive treatment. Proc Natl Acad Sci U S A. 2009;106:9027–9032. doi: 10.1073/pnas.090141510619451638
5. Minja DT, Schmiegelow C, Mmbando B, Bostrom S, Oesterholt M, Magistrado P, et al. Plasmodium falciparum mutant haplotype infection during pregnancy associated with reduced birthweight, Tanzania. Emerg Infect Dis. 2013;19. doi: 10.3201/eid1909.130133
6. Gutman J, Kalilani L, Taylor S, Zhou Z, Wiegand RE, Thwai KL, et al. The A581G mutation in the gene encoding Plasmodium falciparum dihydropteroate synthetase reduces the effectiveness of sulfadoxine-pyrimethamine preventive therapy in Malawian pregnant women. J Infect Dis. 2015;211:1997–2005. doi: 10.1093/infdis/jiu83625564249
7. Clerk CA, Bruce J, Affipunguh PK, Mensah N, Hodgson A, Greenwood B, et al. A randomized, controlled trial of intermittent preventive treatment with sulfadoxine-pyrimethamine, amodiaquine, or the combination in pregnant women in Ghana. J Infect Dis. 2008;198:1202–1211. doi: 10.1086/59194418752443
8. Gonzalez R, Desai M, Macete E, Ouma P, Kakolwa MA, Abdulla S, et al. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial. PLoS Med. 2014;11:e1001735. doi: 10.1371/journal.pmed.100173525247995
9. Gonzalez R, Mombo-Ngoma G, Ouedraogo S, Kakolwa MA, Abdulla S, Accrombessi M, et al. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. PLoS Med. 2014;11:e1001733. doi: 10.1371/journal.pmed.100173325247709
10. Chandra RS, Orazem J, Ubben D, Duparc S, Robbins J, Vandenbroucke P, Creative solutions to extraordinary challenges in clinical trials: methodology of a phase III trial of azithromycin and chloroquine fixed-dose combination in pregnant women in Africa. Malar J. 2013;12:122. doi: 10.1186/1475-2875-12-12223577619
11. Tagbor H, Bruce J, Agbo M, Greenwood B, Chandramohan D, Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: a randomised controlled non-inferiority trial. PLoS ONE. 2010;5:e14425. doi: 10.1371/journal.pone.001442521203389
12. Tagbor H, Cairns M, Bojang K, Coulibaly SO, Kayentao K, Williams J, et al. A non-inferiority, individually randomized trial of intermittent screening and treatment versus intermittent preventive treatment in the control of malaria in pregnancy. PLoS ONE. 2015;10:e0132247. doi: 10.1371/journal.pone.013224726258474
13. Smith LA, Jones C, Adjei RO, Antwi GD, Afrah NA, Greenwood B, et al. Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: user acceptability. Malar J. 2010;9:18. doi: 10.1186/1475-2875-9-1820074372
14. Smith Paintain L, Antwi GD, Jones C, Amoako E, Adjei RO, Afrah NA, et al. Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: provider knowledge and acceptability. PLoS ONE. 2011;6:e24035. doi: 10.1371/journal.pone.002403521887367
15. Desai M, Gutman J, L’Lanziva A, Otieno K, Juma E, Kariuki S, et al. Intermittent screening and treatment or intermittent preventive treatment with dihydroartemisinin-piperaquine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for the control of malaria during pregnancy in western Kenya: an open-label, three-group, randomised controlled superiority trial. Lancet. 2015;386:2507–2519. doi: 10.1016/S0140-6736(15)00310-426429700
16. Taylor SM, Antonia AL, Chaluluka E, Mwapasa V, Feng G, Molyneux ME, et al. Antenatal receipt of sulfadoxine-pyrimethamine does not exacerbate pregnancy-associated malaria despite the expansion of drug-resistant Plasmodium falciparum: clinical outcomes from the QuEERPAM Study. Clin Infect Dis. 2012;55:42–50. doi: 10.1093/cid/cis30122441649
17. Artimovich E, Schneider K, Taylor TE, Kublin JG, Dzinjalamala FK, Escalante AA, et al. Persistence of sulfadoxine-pyrimethamine resistance despite reduction of drug pressure in Malawi. J Infect Dis. 2015;212:694–701. doi: 10.1093/infdis/jiv07825672905
18. Ballard JL, Khoury JC, Wedig K, Wang L, Eilers-Walsman BL, Lipp R, New Ballard Score, expanded to include extremely premature infants. J Pediatr. 1991;119:417–423. 1880657
19. Schmiegelow C, Scheike T, Oesterholt M, Minja D, Pehrson C, Magistrado P, et al. Development of a fetal weight chart using serial trans-abdominal ultrasound in an East African population: a longitudinal observational study. PLoS ONE. 2012;7:e44773. doi: 10.1371/journal.pone.004477323028617
20. Gamble C, Ekwaru JP, ter Kuile FO, Insecticide-treated nets for preventing malaria in pregnancy. Cochrane Database Syst Rev. 2006;2006:CD003755. doi: 10.1002/14651858.CD003755.pub2
21. ter Kuile FO, van Eijk AM, Filler SJ, Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review. JAMA. 2007;297:2603–2616. 17579229
22. Le Hesran JY, Cot M, Personne P, Fievet N, Dubois B, Beyeme M, et al. Maternal placental infection with Plasmodium falciparum and malaria morbidity during the first 2 years of life. Am J Epidemiol. 1997;146:826–831. 9384203
23. Malhotra I, Dent A, Mungai P, Wamachi A, Ouma JH, Narum DL, et al. Can prenatal malaria exposure produce an immune tolerant phenotype? A prospective birth cohort study in Kenya. PLoS Med. 2009;6:e1000116. doi: 10.1371/journal.pmed.100011619636353
24. Mutabingwa TK, Bolla MC, Li JL, Domingo GJ, Li X, Fried M, et al. Maternal malaria and gravidity interact to modify infant susceptibility to malaria. PLoS Med. 2005;2:e407. doi: 10.1371/journal.pmed.002040716259531
25. Schwarz NG, Adegnika AA, Breitling LP, Gabor J, Agnandji ST, Newman RD, et al. Placental malaria increases malaria risk in the first 30 months of life. Clin Infect Dis. 2008;47:1017–1025. doi: 10.1086/59196818781874
26. Cornet M, Le Hesran JY, Fievet N, Cot M, Personne P, Gounoue R, et al. Prevalence of and risk factors for anemia in young children in southern Cameroon. Am J Trop Med Hyg. 1998;58:606–611. 9598449
27. van Eijk AM, Ayisi JG, Ter Kuile FO, Misore AO, Otieno JA, Kolczak MS, et al. Malaria and human immunodeficiency virus infection as risk factors for anemia in infants in Kisumu, western Kenya. Am J Trop Med Hyg. 2002;67:44–53. 12363063
28. Reed SC, Wirima JJ, Steketee RW, Risk factors for anemia in young children in rural Malawi. Am J Trop Med Hyg. 1994;51:170–174. 8074250
29. Naidoo I, Roper C, Mapping ‘partially resistant’, ‘fully resistant’, and ‘super resistant’ malaria. Trends Parasitol. 2013;29:505–515. doi: 10.1016/j.pt.2013.08.00224028889
30. The PREGACT Study GroupPekyi D, Ampromfi AA, Tinto H, Traore-Coulibaly M, Tahita MC, et al. Four artemisinin-based treatments in African pregnant women with malaria. N Engl J Med. 2016;374:913–927. doi: 10.1056/NEJMoa150860626962727
31. Kayentao K, Garner P, van Eijk AM, Naidoo I, Roper C, Mulokozi A, et al. Intermittent preventive therapy for malaria during pregnancy using 2 vs 3 or more doses of sulfadoxine-pyrimethamine and risk of low birth weight in Africa: systematic review and meta-analysis. JAMA. 2013;309:594–604. doi: 10.1001/jama.2012.21623123403684
32. Capan M, Mombo-Ngoma G, Makristathis A, Ramharter M, Anti-bacterial activity of intermittent preventive treatment of malaria in pregnancy: comparative in vitro study of sulphadoxine-pyrimethamine, mefloquine, and azithromycin. Malar J. 2010;9:303. doi: 10.1186/1475-2875-9-30321029476
33. Rijken MJ, McGready R, Phyo AP, Lindegardh N, Tarning J, Laochan N, et al. Pharmacokinetics of dihydroartemisinin and piperaquine in pregnant and nonpregnant women with uncomplicated falciparum malaria. Antimicrob Agents Chemother. 2011;55:5500–5506. doi: 10.1128/aac.05067-1121947392
34. Nambozi M, Mulenga M, Halidou T, Tagbor H, Mwapasa V, Phiri LK, et al. Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial. Reprod Health. 2015;12:5. doi: 10.1186/1742-4755-12-525592254
35. Williams JE, Cairns M, Njie F, Laryea Quaye S, Awine T, Oduro A, et al. The performance of a rapid diagnostic test in detecting malaria infection in pregnant women and the impact of missed infections. Clin Infect Dis. 2016;62:837–844. doi: 10.1093/cid/civ119826721833
36. Gamble C, Ekwaru PJ, Garner P, ter Kuile FO, Insecticide-treated nets for the prevention of malaria in pregnancy: a systematic review of randomised controlled trials. PLoS Med. 2007;4:e107. doi: 10.1371/journal.pmed.004010717388668
37. Pell C, Menaca A, Chatio S, Hodgson A, Tagbor H, Pool R, The acceptability of intermittent screening and treatment versus intermittent preventive treatment during pregnancy: results from a qualitative study in Northern Ghana. Malar J. 2014;13:432. doi: 10.1186/1475-2875-13-43225404126