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Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali


Autoři: Matthew E. Cairns aff001;  Issaka Sagara aff002;  Issaka Zongo aff003;  Irene Kuepfer aff004;  Ismaila Thera aff002;  Frederic Nikiema aff003;  Modibo Diarra aff002;  Serge R. Yerbanga aff003;  Amadou Barry aff002;  Amadou Tapily aff002;  Samba Coumare aff002;  Paul Milligan aff001;  Halidou Tinto aff003;  Jean Bosco Ouédraogo aff003;  Daniel Chandramohan aff005;  Brian Greenwood aff005;  Abdoulaye Djimde aff002;  Alassane Dicko aff002
Působiště autorů: Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom aff001;  Malaria Research and Training Centre, Bamako, Mali aff002;  Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso aff003;  Swiss Tropical and Public Health Institute, Basel, Switzerland aff004;  Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom aff005
Vyšlo v časopise: Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali. PLoS Med 17(8): e32767. doi:10.1371/journal.pmed.1003214
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pmed.1003214

Souhrn

Background

Seasonal malaria chemoprevention (SMC) is now widely deployed in the Sahel, including several countries that are major contributors to the global burden of malaria. Consequently, it is important to understand whether SMC continues to provide a high level of protection and how SMC might be improved. SMC was evaluated using data from a large, household-randomised trial in Houndé, Burkina Faso and Bougouni, Mali.

Methods and findings

The parent trial evaluated monthly SMC plus either azithromycin (AZ) or placebo, administered as directly observed therapy 4 times per year between August and November (2014–2016). In July 2014, 19,578 children aged 3–59 months were randomised by household to study group. Children who remained within the age range 3–59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016. These analyses focus on the approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group. Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August. The incidence rate ratio comparing SMC within the past 28 days with SMC more than 35 days ago—adjusted for age, country, and household clustering—was 0.13 (95% CI: 0.08, 0.20), P < 0.001 for malaria hospitalisations and deaths from malaria and 0.21 (95% CI 0.20, 0.23), P < 0.001 for uncomplicated malaria, indicating protective efficacy of 87.4% (95% CI: 79.6%, 92.2%) and 78.3% (95% CI: 76.8%, 79.6%), respectively. The prevalence of malaria parasitaemia at weekly surveys during the rainy season and at the end of the transmission season was several times higher in children who missed the SMC course preceding the survey contact, and the smallest prevalence ratio observed was 2.98 (95% CI: 1.95, 4.54), P < 0.001. The frequency of molecular markers of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance did not increase markedly over the study period either amongst study children or amongst school-age children resident in the study areas. After 3 years of SMC deployment, the day 28 PCR-unadjusted adequate clinical and parasitological response rate of the SP + AQ regimen in children with asymptomatic malaria was 98.3% (95% CI: 88.6%, 99.8%) in Burkina Faso and 96.1% (95% CI: 91.5%, 98.2%) in Mali. Key limitations of this study are the potential overdiagnosis of uncomplicated malaria by rapid diagnostic tests and the potential for residual confounding from factors related to adherence to the monthly SMC schedule.

Conclusion

Despite strong evidence that SMC is providing a high level of protection, the burden of malaria remains substantial in the 2 study areas. These results emphasise the need for continuing support of SMC programmes. A fifth monthly SMC course is needed to adequately cover the whole transmission season in the study areas and in settings with similar epidemiology.

Trial registration

The AZ-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT02211729.

Klíčová slova:

Burkina Faso – Epidemiology – Hospitals – Malaria – Malarial parasites – Mali – Parasitic diseases – Plasmodium


Zdroje

1. Dicko A, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, et al. Intermittent Preventive Treatment of Malaria Provides Substantial Protection against Malaria in Children Already Protected by an Insecticide-Treated Bednet in Mali: A Randomised, Double-Blind, Placebo-Controlled Trial. PLoS Med. 2011;8(2):e1000407. doi: 10.1371/journal.pmed.1000407 21304923

2. Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, et al. Intermittent Preventive Treatment of Malaria Provides Substantial Protection against Malaria in Children Already Protected by an Insecticide-Treated Bednet in Burkina Faso: A Randomised, Double-Blind, Placebo-Controlled Trial. PLoS Med. 2011;8(2):e1000408. doi: 10.1371/journal.pmed.1000408 21304925

3. World Health Organisation. WHO policy recommendation: Seasonal malaria chemoprevention (SMC) for Plasmodium falciparum malaria control in highly seasonal transmission areas of the Sahel sub-region in Africa [Internet]. 2012 [cited 2014 28th May]. http://www.who.int/malaria/publications/atoz/who_smc_policy_recommendation/en/

4. Cairns M, Roca-Feltrer A, Garske T, Wilson AL, Diallo D, Milligan PJ, et al. Estimating the potential public health impact of seasonal malaria chemoprevention in African children. Nature communications. 2012;3:881. doi: 10.1038/ncomms1879 22673908

5. World Health Organisation. World Malaria Report 2018. Geneva: World Health Organisation; 2018.

6. Ndiaye JLA, Ndiaye Y, Ba MS, Faye B, Ndiaye M, Seck A, et al. Seasonal malaria chemoprevention combined with community case management of malaria in children under 10 years of age, over 5 months, in south-east Senegal: A cluster-randomised trial. PLoS Med. 2019;16(3):e1002762. doi: 10.1371/journal.pmed.1002762 30865632

7. Diawara F, Steinhardt LC, Mahamar A, Traore T, Kone DT, Diawara H, et al. Measuring the impact of seasonal malaria chemoprevention as part of routine malaria control in Kita, Mali. Malar J. 2017;16(1):325. doi: 10.1186/s12936-017-1974-x 28797263

8. Druetz T. Evaluation of direct and indirect effects of seasonal malaria chemoprevention in Mali. Scientific reports. 2018;8(1):8104. doi: 10.1038/s41598-018-26474-6 29802375

9. Druetz T, Corneau-Tremblay N, Millogo T, Kouanda S, Ly A, Bicaba A, et al. Impact Evaluation of Seasonal Malaria Chemoprevention under Routine Program Implementation: A Quasi-Experimental Study in Burkina Faso. Am J Trop Med Hyg. 2018;98(2):524–33. Epub 2017 Dec 14. doi: 10.4269/ajtmh.17-0599 29260654

10. Konate D, Diawara SI, Toure M, Diakite SAS, Guindo A, Traore K, et al. Effect of routine seasonal malaria chemoprevention on malaria trends in children under 5 years in Dangassa, Mali. Malar J. 2020;19(1):137. doi: 10.1186/s12936-020-03202-y 32252774

11. Issiaka D, Barry A, Traore T, Diarra B, Cook D, Keita M, et al. Impact of seasonal malaria chemoprevention on hospital admissions and mortality in children under 5 years of age in Ouelessebougou, Mali. Malar J. 2020;19(1):103. doi: 10.1186/s12936-020-03175-y 32126989

12. World Health Organisation. High burden to high impact: a targeted malaria response. Geneva: World Health Organisation; 2018.

13. Cisse B, Ba EH, Sokhna C, Ndiaye J, Gomis JF, Dial Y, et al. Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial. PLoS Med. 2016;13(11):e1002175. doi: 10.1371/journal.pmed.1002175 27875528

14. Greenwood B, Dicko A, Sagara I, Zongo I, Tinto H, Cairns M, et al. Seasonal vaccination against malaria: a potential use for an imperfect malaria vaccine. Malar J. 2017;16(1):182. doi: 10.1186/s12936-017-1841-9 28464937

15. Beshir K, Sutherland C. Baseline molecular data before scaling-up access to seasonal malaria chemoprevention in seven countries across the Sahel. In: The 7th Multilateral Initiative on Malaria Panafrican Conference, entitled «Two decades of progress, challenges and perspectives in ending Malaria». Dakar, Senegal; 2018. Presentation #249. https://mesamalaria.org/resource-hub/mim-2018-conference-abstract-book

16. Cairns M, Ceesay SJ, Sagara I, Zongo I, Kessely H, Gamougam K, et al. Monitoring the protective efficacy of seasonal malaria chemoprevention using case-control studies: methodology and results from 5 countries. In: The 7th Multilateral Initiative on Malaria Panafrican Conference, entitled «Two decades of progress, challenges and perspectives in ending Malaria». Dakar, Senegal; 2018. Presentation #251. https://mesamalaria.org/resource-hub/mim-2018-conference-abstract-book

17. Chandramohan D, Dicko A, Zongo I, Sagara I, Cairns M, Kuepfer I, et al. Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention. N Engl J Med. 2019;380(23):2197–206. doi: 10.1056/NEJMoa1811400 30699301.

18. Swysen C, Vekemans J, Bruls M, Oyakhirome S, Drakeley C, Kremsner P, et al. Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine. Malar J. 2011;10:223. doi: 10.1186/1475-2875-10-223 21816032

19. World Health Organisation. Verbal autopsy standards: ascertaining and attributing causes of death—the 2016 WHO verbal autopsy instrument. Geneva: World Health Organisation; 2016.

20. Djimde A, Doumbo OK, Cortese JF, Kayentao K, Doumbo S, Diourte Y, et al. A molecular marker for chloroquine-resistant falciparum malaria. N Engl J Med. 2001;344(4):257–63. doi: 10.1056/NEJM200101253440403 11172152.

21. Plowe CV, Djimde A, Bouare M, Doumbo O, Wellems TE. Pyrimethamine and proguanil resistance-conferring mutations in Plasmodium falciparum dihydrofolate reductase: polymerase chain reaction methods for surveillance in Africa. Am J Trop Med Hyg. 1995;52(6):565–8. doi: 10.4269/ajtmh.1995.52.565 7611566.

22. Cheung YB, Xu Y, Cairns M, Milligan P. Evaluation of the impact of disease prevention measures: a methodological note on defining incidence rates. BMC medical research methodology. 2017;17(1):72. doi: 10.1186/s12874-017-0350-4 28431516

23. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159(7):702–6. doi: 10.1093/aje/kwh090 15033648.

24. World Health Organisation. Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations. Geneva: World Health Organisation; 2008.

25. Zongo I, Milligan P, Compaore YD, Some AF, Greenwood B, Tarning J, et al. Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso. Antimicrob Agents Chemother. 2015;59(8):4387–96. doi: 10.1128/AAC.04923-14 25918149

26. ACCESS-SMC Partnership. Evaluation of SMC Coverage, safety, efficacy, impact and drug resistance: Summary of progress and preliminary results—April 2017 [Internet]. 2017 [cited 2020 Jan 1]. https://files.givewell.org/files/DWDA%202009/Malaria%20Consortium/ACCESS-SMC_Research_progress_update_April_2017.pdf

27. Cairns M, Ghani A, Okell L, Gosling R, Carneiro I, Anto F, et al. Modelling the protective efficacy of alternative delivery schedules for intermittent preventive treatment of malaria in infants and children. PLoS ONE. 2011;6(4):e18947. doi: 10.1371/journal.pone.0018947 21533088

28. Chandramohan D, Owusu-Agyei S, Carneiro I, Awine T, Amponsa-Achiano K, Mensah N, et al. Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. British Medical Journal. 2005;331(7519):727–33. doi: 10.1136/bmj.331.7519.727 16195288

29. Tagbor H, Antwi GD, Acheampong PR, Bart Plange C, Chandramohan D, Cairns M. Seasonal malaria chemoprevention in an area of extended seasonal transmission in Ashanti, Ghana: an individually randomised clinical trial. Trop Med Int Health. 2016;21(2):224–35. Epub 2015 Dec 16. doi: 10.1111/tmi.12642 26578353.


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