title: 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 (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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute of Tropical Diseases Research and Prevention, University of Calabar Teaching Hospital-UCTH, Calabar, Cross River State, Nigeria. mmeremiku@yahoo.co.uk
authors.forename: Martin M
authors.initials: MM
authors.lastname: Meremikwu
authors.forename: Friday
authors.initials: F
authors.lastname: Odey
authors.forename: Chioma
authors.initials: C
authors.lastname: Oringanje
authors.forename: Angela
authors.initials: A
authors.lastname: Oyo-Ita
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Effa
authors.forename: Ekpereonne B
authors.initials: EB
authors.lastname: Esu
authors.forename: Eyam
authors.initials: E
authors.lastname: Eyam
authors.forename: Olabisi
authors.initials: O
authors.lastname: Oduwole
authors.forename: Vivian
authors.initials: V
authors.lastname: Asiegbu
authors.forename: Ambrose
authors.initials: A
authors.lastname: Alaribe
authors.forename: Emmanuel N
authors.initials: EN
authors.lastname: Ezedinachi
mesh_terms: D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009285:Naphthoquinones / Q000008:administration & dosage* / Q000009:adverse effects; D009549:Nigeria; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D009285:Naphthoquinones; C543979:artemisinin-naphthoquine combination