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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Malaria Journal 1/2012

Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria

Zeitschrift:
Malaria Journal > Ausgabe 1/2012
Autoren:
Martin M Meremikwu, Friday Odey, Chioma Oringanje, Angela Oyo-ita, Emmanuel Effa, Ekpereonne B Esu, Eyam Eyam, Olabisi Oduwole, Vivian Asiegbu, Ambrose Alaribe, Emmanuel N Ezedinachi
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2875-11-413) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

ENE and MMM contributed to design of the study; FO, CO and MMM coordinated the study, performed data analysis and drafted the paper; EE, FO and EE performed clinical assessment; CO, OO and VA performed laboratory tests, AA supervised laboratory team, EBE contributed to data analysis and drafting of paper. All authors read and approved the final manuscript.

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.
Zusatzmaterial
Authors’ original file for figure 1
12936_2012_2580_MOESM1_ESM.pdf
Authors’ original file for figure 2
12936_2012_2580_MOESM2_ESM.pdf
Authors’ original file for figure 3
12936_2012_2580_MOESM3_ESM.pdf
Literatur
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