Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India
Abstract Background Anti-malarial drug resistance continues to be a leading threat to malaria control efforts and calls for continued monitoring of waning efficacy of artemisinin-based combination therapy (ACT). Artesunate + sulfadoxine/pyrimethamine (AS + SP) is used for the treatment of uncomplica...
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ftdoajarticles:oai:doaj.org/article:d463c28a6e374db5a51ac7d2feed7d07 2023-05-15T15:17:26+02:00 Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India Praveen K. Bharti Man M. Shukla Pascal Ringwald Sri Krishna Pushpendra P. Singh Ajay Yadav Sweta Mishra Usha Gahlot Jai P. Malaiya Amit Kumar Shambhu Prasad Pradeep Baghel Mohan Singh Jaiprakash Vadadi Mrigendra P. Singh Maria Dorina G. Bustos Leonard I. Ortega Eva-Maria Christophel Sher S. Kashyotia Gagan S. Sonal Neeru Singh 2016-10-01T00:00:00Z https://doi.org/10.1186/s12936-016-1555-4 https://doaj.org/article/d463c28a6e374db5a51ac7d2feed7d07 EN eng BMC http://link.springer.com/article/10.1186/s12936-016-1555-4 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-016-1555-4 1475-2875 https://doaj.org/article/d463c28a6e374db5a51ac7d2feed7d07 Malaria Journal, Vol 15, Iss 1, Pp 1-9 (2016) Therapeutic efficacy Artemether–lumefantrine Plasmodium falciparum Malaria India Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2016 ftdoajarticles https://doi.org/10.1186/s12936-016-1555-4 2022-12-31T13:24:27Z Abstract Background Anti-malarial drug resistance continues to be a leading threat to malaria control efforts and calls for continued monitoring of waning efficacy of artemisinin-based combination therapy (ACT). Artesunate + sulfadoxine/pyrimethamine (AS + SP) is used for the treatment of uncomplicated Plasmodium falciparum malaria in India. However, resistance against AS + SP is emerged in northeastern states. Therefore, artemether–lumefantrine (AL) is the recommended first line treatment for falciparum malaria in north eastern states. This study investigates the therapeutic efficacy and safety of AL for the treatment of uncomplicated falciparum malaria in three malaria-endemic states in India. The data generated through this study will benefit the immediate implementation of second-line ACT as and when required. Methods This was a one-arm prospective evaluation of clinical and parasitological responses for uncomplicated falciparum malaria using WHO protocol. Patients diagnosed with uncomplicated mono P. falciparum infection were administered six-dose regimen of AL over 3 days and subsequent follow-up was carried out up to 28 days. Molecular markers msp-1 and msp-2 were used to differentiate recrudescence and re-infection and K13 propeller gene was amplified and sequenced covering the codon 450–680. Results A total of 402 eligible patients were enrolled in the study from all four sites. Overall, adequate clinical and parasitological response (ACPR) was 98 % without PCR correction and 99 % with PCR correction. At three study sites, ACPR rates were 100 %, while at Bastar, cure rate was 92.5 % on day 28. No early treatment failure was found. The PCR-corrected endpoint finding confirmed that one late clinical failure (LCF) and two late parasitological failures (LPF) were recrudescences. The PCR corrected cure rate was 96.5 %. The mean fever clearance time was 27.2 h ± 8.2 (24–48 h) and the mean parasite clearance time was 30.1 h ± 11.0 (24–72 h). Additionally, no adverse event was recorded. Analysis of total 186 ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 15 1 |
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Therapeutic efficacy Artemether–lumefantrine Plasmodium falciparum Malaria India Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
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Therapeutic efficacy Artemether–lumefantrine Plasmodium falciparum Malaria India Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Praveen K. Bharti Man M. Shukla Pascal Ringwald Sri Krishna Pushpendra P. Singh Ajay Yadav Sweta Mishra Usha Gahlot Jai P. Malaiya Amit Kumar Shambhu Prasad Pradeep Baghel Mohan Singh Jaiprakash Vadadi Mrigendra P. Singh Maria Dorina G. Bustos Leonard I. Ortega Eva-Maria Christophel Sher S. Kashyotia Gagan S. Sonal Neeru Singh Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India |
topic_facet |
Therapeutic efficacy Artemether–lumefantrine Plasmodium falciparum Malaria India Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background Anti-malarial drug resistance continues to be a leading threat to malaria control efforts and calls for continued monitoring of waning efficacy of artemisinin-based combination therapy (ACT). Artesunate + sulfadoxine/pyrimethamine (AS + SP) is used for the treatment of uncomplicated Plasmodium falciparum malaria in India. However, resistance against AS + SP is emerged in northeastern states. Therefore, artemether–lumefantrine (AL) is the recommended first line treatment for falciparum malaria in north eastern states. This study investigates the therapeutic efficacy and safety of AL for the treatment of uncomplicated falciparum malaria in three malaria-endemic states in India. The data generated through this study will benefit the immediate implementation of second-line ACT as and when required. Methods This was a one-arm prospective evaluation of clinical and parasitological responses for uncomplicated falciparum malaria using WHO protocol. Patients diagnosed with uncomplicated mono P. falciparum infection were administered six-dose regimen of AL over 3 days and subsequent follow-up was carried out up to 28 days. Molecular markers msp-1 and msp-2 were used to differentiate recrudescence and re-infection and K13 propeller gene was amplified and sequenced covering the codon 450–680. Results A total of 402 eligible patients were enrolled in the study from all four sites. Overall, adequate clinical and parasitological response (ACPR) was 98 % without PCR correction and 99 % with PCR correction. At three study sites, ACPR rates were 100 %, while at Bastar, cure rate was 92.5 % on day 28. No early treatment failure was found. The PCR-corrected endpoint finding confirmed that one late clinical failure (LCF) and two late parasitological failures (LPF) were recrudescences. The PCR corrected cure rate was 96.5 %. The mean fever clearance time was 27.2 h ± 8.2 (24–48 h) and the mean parasite clearance time was 30.1 h ± 11.0 (24–72 h). Additionally, no adverse event was recorded. Analysis of total 186 ... |
format |
Article in Journal/Newspaper |
author |
Praveen K. Bharti Man M. Shukla Pascal Ringwald Sri Krishna Pushpendra P. Singh Ajay Yadav Sweta Mishra Usha Gahlot Jai P. Malaiya Amit Kumar Shambhu Prasad Pradeep Baghel Mohan Singh Jaiprakash Vadadi Mrigendra P. Singh Maria Dorina G. Bustos Leonard I. Ortega Eva-Maria Christophel Sher S. Kashyotia Gagan S. Sonal Neeru Singh |
author_facet |
Praveen K. Bharti Man M. Shukla Pascal Ringwald Sri Krishna Pushpendra P. Singh Ajay Yadav Sweta Mishra Usha Gahlot Jai P. Malaiya Amit Kumar Shambhu Prasad Pradeep Baghel Mohan Singh Jaiprakash Vadadi Mrigendra P. Singh Maria Dorina G. Bustos Leonard I. Ortega Eva-Maria Christophel Sher S. Kashyotia Gagan S. Sonal Neeru Singh |
author_sort |
Praveen K. Bharti |
title |
Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India |
title_short |
Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India |
title_full |
Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India |
title_fullStr |
Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India |
title_full_unstemmed |
Therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria from three highly malarious states in India |
title_sort |
therapeutic efficacy of artemether–lumefantrine for the treatment of uncomplicated plasmodium falciparum malaria from three highly malarious states in india |
publisher |
BMC |
publishDate |
2016 |
url |
https://doi.org/10.1186/s12936-016-1555-4 https://doaj.org/article/d463c28a6e374db5a51ac7d2feed7d07 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 15, Iss 1, Pp 1-9 (2016) |
op_relation |
http://link.springer.com/article/10.1186/s12936-016-1555-4 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-016-1555-4 1475-2875 https://doaj.org/article/d463c28a6e374db5a51ac7d2feed7d07 |
op_doi |
https://doi.org/10.1186/s12936-016-1555-4 |
container_title |
Malaria Journal |
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15 |
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1 |
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1766347670864003072 |