Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria
Abstract Background The use of anti-malarial drug combinations with artemisinin, or with one of its derivatives, is now widely recommended to overcome drug resistance in falciparum malaria. Fixed-dose combination of artemisinin and naphthoquine is a new generation artemisinin combination therapy (AC...
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ftdoajarticles:oai:doaj.org/article:f215ed617c904943bff754a1b272eb9c 2023-05-15T15:13:28+02:00 Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria Meremikwu Martin M Odey Friday Oringanje Chioma Oyo-ita Angela Effa Emmanuel Esu Ekpereonne B Eyam Eyam Oduwole Olabisi Asiegbu Vivian Alaribe Ambrose Ezedinachi Emmanuel N 2012-12-01T00:00:00Z https://doi.org/10.1186/1475-2875-11-413 https://doaj.org/article/f215ed617c904943bff754a1b272eb9c EN eng BMC http://www.malariajournal.com/content/11/1/413 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-11-413 1475-2875 https://doaj.org/article/f215ed617c904943bff754a1b272eb9c Malaria Journal, Vol 11, Iss 1, p 413 (2012) Falciparum malaria Artemisinin Naphthoquine Combination therapy Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2012 ftdoajarticles https://doi.org/10.1186/1475-2875-11-413 2022-12-31T01:27:49Z Abstract Background The use of anti-malarial drug combinations with artemisinin, or with one of its derivatives, is now widely recommended to overcome drug resistance in falciparum malaria. Fixed-dose combination of artemisinin and naphthoquine is a new generation artemisinin combination therapy (ACT) offered as a single dose therapy. The aim of the study was to assess the therapeutic efficacy, safety and tolerability of three dosage schedules of fixed-dose combination of artemisinin (125 mg) and naphthoquine (50 mg) for treating uncomplicated Plasmodium falciparum malaria among adolescents and adults in Calabar, South-east Nigeria. Method A total of 121 patients aged ≥15 years with uncomplicated P . falciparum malaria were enrolled and randomly assigned to three dosage schedules: (A) 700 mg (four tablets) single dose; (B) 700 mg 12-hourly x two doses; and (C) 1,400 mg (eight tablets) single dose. Patients were observed for 28 days, with clinical, parasitological, and haematological assessments. Results A total of 108 patients completed the study. The overall 28-day cure rate was 88.9%. Day 28-cure rates of the three dosage schedules were 85.3%, 93.1% and 88.9% for Group A, B and C respectively. Adverse events were few and mild, the commonest being weakness and headache; there was no serious adverse event. Conclusion Concerns for emergence of parasite resistance due to the use of artemisinin-naphthoquine as single dose regimen is likely to compromise the usefulness of this potentially important combination treatment. A robust multi-centre trial is recommended to evaluate a three-day regimen with potentials to achieve high cure rates while minimizing the risk of emergence of resistant parasite strains. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 11 1 |
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collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Falciparum malaria Artemisinin Naphthoquine Combination therapy Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Falciparum malaria Artemisinin Naphthoquine Combination therapy Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Meremikwu Martin M Odey Friday Oringanje Chioma Oyo-ita Angela Effa Emmanuel Esu Ekpereonne B Eyam Eyam Oduwole Olabisi Asiegbu Vivian Alaribe Ambrose Ezedinachi Emmanuel N Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria |
topic_facet |
Falciparum malaria Artemisinin Naphthoquine Combination therapy Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background The use of anti-malarial drug combinations with artemisinin, or with one of its derivatives, is now widely recommended to overcome drug resistance in falciparum malaria. Fixed-dose combination of artemisinin and naphthoquine is a new generation artemisinin combination therapy (ACT) offered as a single dose therapy. The aim of the study was to assess the therapeutic efficacy, safety and tolerability of three dosage schedules of fixed-dose combination of artemisinin (125 mg) and naphthoquine (50 mg) for treating uncomplicated Plasmodium falciparum malaria among adolescents and adults in Calabar, South-east Nigeria. Method A total of 121 patients aged ≥15 years with uncomplicated P . falciparum malaria were enrolled and randomly assigned to three dosage schedules: (A) 700 mg (four tablets) single dose; (B) 700 mg 12-hourly x two doses; and (C) 1,400 mg (eight tablets) single dose. Patients were observed for 28 days, with clinical, parasitological, and haematological assessments. Results A total of 108 patients completed the study. The overall 28-day cure rate was 88.9%. Day 28-cure rates of the three dosage schedules were 85.3%, 93.1% and 88.9% for Group A, B and C respectively. Adverse events were few and mild, the commonest being weakness and headache; there was no serious adverse event. Conclusion Concerns for emergence of parasite resistance due to the use of artemisinin-naphthoquine as single dose regimen is likely to compromise the usefulness of this potentially important combination treatment. A robust multi-centre trial is recommended to evaluate a three-day regimen with potentials to achieve high cure rates while minimizing the risk of emergence of resistant parasite strains. |
format |
Article in Journal/Newspaper |
author |
Meremikwu Martin M Odey Friday Oringanje Chioma Oyo-ita Angela Effa Emmanuel Esu Ekpereonne B Eyam Eyam Oduwole Olabisi Asiegbu Vivian Alaribe Ambrose Ezedinachi Emmanuel N |
author_facet |
Meremikwu Martin M Odey Friday Oringanje Chioma Oyo-ita Angela Effa Emmanuel Esu Ekpereonne B Eyam Eyam Oduwole Olabisi Asiegbu Vivian Alaribe Ambrose Ezedinachi Emmanuel N |
author_sort |
Meremikwu Martin M |
title |
Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria |
title_short |
Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria |
title_full |
Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria |
title_fullStr |
Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria |
title_full_unstemmed |
Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria |
title_sort |
open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, nigeria |
publisher |
BMC |
publishDate |
2012 |
url |
https://doi.org/10.1186/1475-2875-11-413 https://doaj.org/article/f215ed617c904943bff754a1b272eb9c |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 11, Iss 1, p 413 (2012) |
op_relation |
http://www.malariajournal.com/content/11/1/413 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-11-413 1475-2875 https://doaj.org/article/f215ed617c904943bff754a1b272eb9c |
op_doi |
https://doi.org/10.1186/1475-2875-11-413 |
container_title |
Malaria Journal |
container_volume |
11 |
container_issue |
1 |
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1766344027109588992 |