Author:
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Blasco B, Leroy D, Fidock DA, 2017. Antimalarial drug resistance: linking Plasmodium falciparum parasite biology to the clinic. Nat Med 23: 917–928.
-
2.
WHO, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria. Geneva, Switzerland: World Health Organization.
-
3.
WHO, 2009. Methods for Surveillance of Antimalarial Drug Efficacy. Geneva, Switzerland: World Health Organization.
-
4.
Abukari Z, Okonu R, Nyarko SB, Lo AC, Dieng CC, Salifu SP, Gyan BA, Lo E, Amoah LE, 2019. The diversity, multiplicity of infection and population structure of P. falciparum parasites circulating in asymptomatic carriers living in high and low malaria transmission settings of Ghana. Genes 10: 434.
-
5.
Yakubu B, Longdet IY, Horsefield T, Davou DT, Obishakin E, 2019. High-complexity Plasmodium falciparum infections, north central Nigeria, 2015–2018. Emerg Infect Dis 25: 1330–1338.
-
6.
WHO, 2007. Methods and Techniques for Clinical Trials on Antimalarial Drug Efficacy: Genotyping to Identify Parasite Populations. Geneva, Switzerland: World Health Organization.
-
7.
Dahal P et al. 2019. Competing risk events in antimalarial drug trials in uncomplicated Plasmodium falciparum malaria: a worldwide antimalarial resistance network individual participant data meta-analysis. Malar J 18: 225.
-
8.
Takata J, Sondo P, Humphreys GS, Burrow R, Maguire B, Hossain MS, Das D, Commons RJ, Price RN, Guerin PJ, 2020. The worldwide antimalarial resistance network clinical trials publication library: a live, open-access database of Plasmodium treatment efficacy trials. Am J Trop Med Hyg 103: 359–368.
-
9.
Siribié M, Diarra A, Tiono AB, Soulama I, Sirima SB, 2012. Efficacité de l’artéméther-luméfantrine dans le traitement du paludisme simple de l’enfant en milieu rural au Burkina Faso en 2009. Bull Soc Pathol Exot 105: 202–207.
-
10.
The PREGACT Study Group, 2016. Four artemisinin-based treatments in African pregnant women with malaria. N Engl J Med 374: 913–927.
-
11.
WHO. World Malaria Report 2019. Geneva, Switzerland: World Health Organization.
-
12.
Conrad MD, Rosenthal PJ, 2019. Antimalarial drug resistance in Africa: the calm before the storm? Lancet Infect Dis 19: e338–e351.
-
13.
Taichman DB et al. 2016. Sharing clinical trial data — a proposal from the international committee of medical journal editors. N Engl J Med 374: 384–386.
-
14.
Siebert M, Gaba JF, Caquelin L, Gouraud H, Dupuy A, Moher D, Naudet F, 2020. Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations. BMJ Open 10: e038887.
-
15.
Happi CT, Gbotosho GO, Sowunmi A, Falade CO, Akinboye DO, Gerena L, Kyle DE, Milhous W, Wirth DF, Oduola AMJ, 2004. Molecular analysis of Plasmodium falciparum recrudescent malaria infections in children treated with chloroquine in Nigeria. Am J Trop Med Hyg 70: 20–26.
-
16.
Beck S, Mockenhaupt FP, Bienzle U, Eggelte TA, Thompson WN, Stark K, 2001. Multiplicity of Plasmodium falciparum infection in pregnancy. Am J Trop Med Hyg 65: 631–636.
-
17.
Mahdi Abdel Hamid M, Elamin AF, Albsheer MMA, Abdalla AAA, Mahgoub NS, Mustafa SO, Muneer MS, Amin M, 2016. Multiplicity of infection and genetic diversity of Plasmodium falciparum isolates from patients with uncomplicated and severe malaria in Gezira state, Sudan. Parasites Vectors 9: 362.
-
18.
Kiwuwa MS, Ribacke U, Moll K, Byarugaba J, Lundblom K, Färnert A, Fred K, Wahlgren M, 2013. Genetic diversity of Plasmodium falciparum infections in mild and severe malaria of children from Kampala, Uganda. Parasitol Res 112: 1691–1700.
-
19.
Eldh M et al. 2020. Multiplicity of asymptomatic Plasmodium falciparum infections and risk of clinical malaria: a systematic review and pooled analysis of individual participant data. J Infect Dis 221: 775–785.
-
20.
Dahal P, Simpson JA, Dorsey G, Guérin PJ, Price RN, Stepniewska K, 2017. Statistical methods to derive efficacy estimates of anti-malarials for uncomplicated Plasmodium falciparum malaria: pitfalls and challenges. Malar J 16: 430.
-
21.
Juliano JJ, Gadalla N, Sutherland CJ, Meshnick SR, 2010. The perils of PCR: can we accurately ‘correct’ antimalarial trials? Trends Parasitol 26: 119–124.
-
22.
Jones S, Kay K, Hodel EM, Chy S, Mbituyumuremyi A, Uwimana A, Menard D, Felger I, Hastings I, 2019. Improving methods for analyzing antimalarial drug efficacy trials: molecular correction based on length-polymorphic markers msp-1, msp-2, and glurp. Antimicrob Agents Chemother 63: e00590–e00619.
-
23.
Felger I, Snounou G, Hastings I, Moehrle JJ, Beck HP, 2020. PCR correction strategies for malaria drug trials: updates and clarifications. Lancet Infect Dis 20: e20–e25.
-
24.
Plucinski MM, Morton L, Bushman M, Dimbu PR, Udhayakumar V, 2015. Robust algorithm for systematic classification of malaria late treatment failures as recrudescence or reinfection using microsatellite genotyping. Antimicrob Agents Chemother 59: 6096–6100.
-
25.
Collins WJ, Greenhouse B, Rosenthal PJ, Dorsey G, 2006. The use of genotyping in antimalarial clinical trials: a systematic review of published studies from 1995–2005. Malar J 5: 122.
-
26.
Anon. Consort - Downloads. Available at: http://www.consort-statement.org/downloads. Accessed October 17, 2020.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1078 | 164 | 19 |
| Full Text Views | 543 | 233 | 6 |
| PDF Downloads | 293 | 63 | 2 |
Variation in Calculating and Reporting Antimalarial Efficacy against Plasmodium falciparum in Sub-Saharan Africa: A Systematic Review of Published Reports
Mateusz M. Plucinski
Mateusz M. Plucinski
Malaria Branch and U.S. President’s Malaria Initiative, Centers for Disease Control and Prevention, Atlanta, Georgia;
Search for other papers by Mateusz M. Plucinski in
Current site
Google Scholar
PubMed
Search for other papers by Mateusz M. Plucinski in
Current site
Google Scholar
PubMed
Ian M. Hastings
Ian M. Hastings
Parasitology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom;
Search for other papers by Ian M. Hastings in
Current site
Google Scholar
PubMed
Search for other papers by Ian M. Hastings in
Current site
Google Scholar
PubMed
Leah F. Moriarty
Leah F. Moriarty
Malaria Branch and U.S. President’s Malaria Initiative, Centers for Disease Control and Prevention, Atlanta, Georgia;
Search for other papers by Leah F. Moriarty in
Current site
Google Scholar
PubMed
Search for other papers by Leah F. Moriarty in
Current site
Google Scholar
PubMed
Meera Venkatesan
Meera Venkatesan
U.S. President’s Malaria Initiative, United States Agency for International Development, Washington, District of Columbia;
Search for other papers by Meera Venkatesan in
Current site
Google Scholar
PubMed
Search for other papers by Meera Venkatesan in
Current site
Google Scholar
PubMed
Ingrid Felger
Ingrid Felger
University of Basel, Basel, Switzerland;
Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland
Search for other papers by Ingrid Felger in
Current site
Google Scholar
PubMed
Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland
Search for other papers by Ingrid Felger in
Current site
Google Scholar
PubMed
Eric S. Halsey
Eric S. Halsey
Malaria Branch and U.S. President’s Malaria Initiative, Centers for Disease Control and Prevention, Atlanta, Georgia;
Search for other papers by Eric S. Halsey in
Current site
Google Scholar
PubMed
Search for other papers by Eric S. Halsey in
Current site
Google Scholar
PubMed
ABSTRACT
Antimalarials, in particular artemisinin-based combination therapies (ACTs), are critical tools in reducing the global burden of malaria, which is concentrated in sub-Saharan Africa. Performing and reporting antimalarial efficacy studies in a transparent and standardized fashion permit comparison of efficacy outcomes across countries and time periods. This systematic review summarizes study compliance with WHO laboratory and reporting guidance pertaining to antimalarial therapeutic efficacy studies and evaluates how well studies from sub-Saharan Africa adhered to these guidelines. We included all published studies (January 2020 or before) performed in sub-Saharan Africa where ACT efficacy for treatment of uncomplicated Plasmodium falciparum infection was reported. The primary outcome was a composite indicator for study methodology consistent with WHO guidelines for statistical analysis of corrected efficacy, defined as an article presenting a Kaplan–Meier survival analysis of corrected efficacy or reporting a per-protocol analysis where new infections were excluded from the numerator and denominator. Of 581 articles screened, we identified 279 for the review. Molecular correction was used in 83% (232/279) to distinguish new infections from recrudescences in subjects experiencing recurrent parasitemia. Only 45% (99/221) of articles with therapeutic efficacy as a primary outcome and performing molecular correction reported corrected efficacy outcomes calculated in a way consistent with WHO recommendations. These results indicate a widespread lack of compliance with WHO-recommended methods of analysis, which may result in biases in how antimalarial effectiveness is being measured and reported from sub-Saharan Africa.
- Supplemental Materials (PDF 188.13 KB)
- Supplemental Materials (XLSX 175.39 KB)
- Supplemental Materials (PDF 519.33 KB)
- Supplemental Materials (PDF 534.40 KB)
- Supplemental Materials (PDF 512.73 KB)
Author Notes
Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention or the U.S. Agency for International Development.
Disclosure: M. M. P., L. F. M., M. V., and E. S. H. were supported by the U.S. President’s Malaria Initiative.
Authors’ addresses: Mateusz M. Plucinski, Leah F. Moriarty, and Eric S. Halsey, Centers for Disease Control and Prevention, Atlanta, GA, E-mails: wif7@cdc.gov, wvp4@cdc.gov, and ycw8@cdc.gov. Ian M. Hastings, Department of Parasitology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom, E-mail: ian.hastings@lstmed.ac.uk. Meera Venkatesan, United States Agency for International Development, Bureau for Global Health, Washington, DC, E-mail: mvenkatesan@usaid.gov. Ingrid Felger, University of Basel, Basel, Switzerland, E-mail: ingrid.felger@swisstph.ch.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Blasco B, Leroy D, Fidock DA, 2017. Antimalarial drug resistance: linking Plasmodium falciparum parasite biology to the clinic. Nat Med 23: 917–928.
-
2.
WHO, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria. Geneva, Switzerland: World Health Organization.
-
3.
WHO, 2009. Methods for Surveillance of Antimalarial Drug Efficacy. Geneva, Switzerland: World Health Organization.
-
4.
Abukari Z, Okonu R, Nyarko SB, Lo AC, Dieng CC, Salifu SP, Gyan BA, Lo E, Amoah LE, 2019. The diversity, multiplicity of infection and population structure of P. falciparum parasites circulating in asymptomatic carriers living in high and low malaria transmission settings of Ghana. Genes 10: 434.
-
5.
Yakubu B, Longdet IY, Horsefield T, Davou DT, Obishakin E, 2019. High-complexity Plasmodium falciparum infections, north central Nigeria, 2015–2018. Emerg Infect Dis 25: 1330–1338.
-
6.
WHO, 2007. Methods and Techniques for Clinical Trials on Antimalarial Drug Efficacy: Genotyping to Identify Parasite Populations. Geneva, Switzerland: World Health Organization.
-
7.
Dahal P et al. 2019. Competing risk events in antimalarial drug trials in uncomplicated Plasmodium falciparum malaria: a worldwide antimalarial resistance network individual participant data meta-analysis. Malar J 18: 225.
-
8.
Takata J, Sondo P, Humphreys GS, Burrow R, Maguire B, Hossain MS, Das D, Commons RJ, Price RN, Guerin PJ, 2020. The worldwide antimalarial resistance network clinical trials publication library: a live, open-access database of Plasmodium treatment efficacy trials. Am J Trop Med Hyg 103: 359–368.
-
9.
Siribié M, Diarra A, Tiono AB, Soulama I, Sirima SB, 2012. Efficacité de l’artéméther-luméfantrine dans le traitement du paludisme simple de l’enfant en milieu rural au Burkina Faso en 2009. Bull Soc Pathol Exot 105: 202–207.
-
10.
The PREGACT Study Group, 2016. Four artemisinin-based treatments in African pregnant women with malaria. N Engl J Med 374: 913–927.
-
11.
WHO. World Malaria Report 2019. Geneva, Switzerland: World Health Organization.
-
12.
Conrad MD, Rosenthal PJ, 2019. Antimalarial drug resistance in Africa: the calm before the storm? Lancet Infect Dis 19: e338–e351.
-
13.
Taichman DB et al. 2016. Sharing clinical trial data — a proposal from the international committee of medical journal editors. N Engl J Med 374: 384–386.
-
14.
Siebert M, Gaba JF, Caquelin L, Gouraud H, Dupuy A, Moher D, Naudet F, 2020. Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations. BMJ Open 10: e038887.
-
15.
Happi CT, Gbotosho GO, Sowunmi A, Falade CO, Akinboye DO, Gerena L, Kyle DE, Milhous W, Wirth DF, Oduola AMJ, 2004. Molecular analysis of Plasmodium falciparum recrudescent malaria infections in children treated with chloroquine in Nigeria. Am J Trop Med Hyg 70: 20–26.
-
16.
Beck S, Mockenhaupt FP, Bienzle U, Eggelte TA, Thompson WN, Stark K, 2001. Multiplicity of Plasmodium falciparum infection in pregnancy. Am J Trop Med Hyg 65: 631–636.
-
17.
Mahdi Abdel Hamid M, Elamin AF, Albsheer MMA, Abdalla AAA, Mahgoub NS, Mustafa SO, Muneer MS, Amin M, 2016. Multiplicity of infection and genetic diversity of Plasmodium falciparum isolates from patients with uncomplicated and severe malaria in Gezira state, Sudan. Parasites Vectors 9: 362.
-
18.
Kiwuwa MS, Ribacke U, Moll K, Byarugaba J, Lundblom K, Färnert A, Fred K, Wahlgren M, 2013. Genetic diversity of Plasmodium falciparum infections in mild and severe malaria of children from Kampala, Uganda. Parasitol Res 112: 1691–1700.
-
19.
Eldh M et al. 2020. Multiplicity of asymptomatic Plasmodium falciparum infections and risk of clinical malaria: a systematic review and pooled analysis of individual participant data. J Infect Dis 221: 775–785.
-
20.
Dahal P, Simpson JA, Dorsey G, Guérin PJ, Price RN, Stepniewska K, 2017. Statistical methods to derive efficacy estimates of anti-malarials for uncomplicated Plasmodium falciparum malaria: pitfalls and challenges. Malar J 16: 430.
-
21.
Juliano JJ, Gadalla N, Sutherland CJ, Meshnick SR, 2010. The perils of PCR: can we accurately ‘correct’ antimalarial trials? Trends Parasitol 26: 119–124.
-
22.
Jones S, Kay K, Hodel EM, Chy S, Mbituyumuremyi A, Uwimana A, Menard D, Felger I, Hastings I, 2019. Improving methods for analyzing antimalarial drug efficacy trials: molecular correction based on length-polymorphic markers msp-1, msp-2, and glurp. Antimicrob Agents Chemother 63: e00590–e00619.
-
23.
Felger I, Snounou G, Hastings I, Moehrle JJ, Beck HP, 2020. PCR correction strategies for malaria drug trials: updates and clarifications. Lancet Infect Dis 20: e20–e25.
-
24.
Plucinski MM, Morton L, Bushman M, Dimbu PR, Udhayakumar V, 2015. Robust algorithm for systematic classification of malaria late treatment failures as recrudescence or reinfection using microsatellite genotyping. Antimicrob Agents Chemother 59: 6096–6100.
-
25.
Collins WJ, Greenhouse B, Rosenthal PJ, Dorsey G, 2006. The use of genotyping in antimalarial clinical trials: a systematic review of published studies from 1995–2005. Malar J 5: 122.
-
26.
Anon. Consort - Downloads. Available at: http://www.consort-statement.org/downloads. Accessed October 17, 2020.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1078 | 164 | 19 |
| Full Text Views | 543 | 233 | 6 |
| PDF Downloads | 293 | 63 | 2 |