Abstract
BackgroundFirst-line schizontocidal treatment for uncomplicated malaria in the Republic of the Sudan is artesunate (total dose 12 mg/kg) plus Sulphadoxine/pyrimethamine (25/1.25 mg/kg) (AS/SP). Patients with Plasmodium vivax are also treated with 14 days primaquine (total dose 3.5 mg/kg) (PQ). The aim of this study was to assess the efficacy of the national policy.MethodsPatients above 1 year, with microscopy-confirmed, Plasmodium falciparum and/or P. vivax malaria were treated with AS/SP. Patients with P. falciparum were randomized to no primaquine (Pf-noPQ) or a single 0.25 mg/kg dose of PQ (Pf-PQ1). Patients with P. vivax received 14 days unsupervised 3.5 mg/kg PQ (Pv-PQ14) on day 2 or at the end of follow up (Pv-noPQ). Primary endpoint was the risk of recurrent parasitaemia at day 42. G6PD activity was measured by spectrophotometry and the Accessbio Biosensor™.Results231 patients with P. falciparum (74.8%), 77 (24.9%) with P. vivax and 1 (0.3%) patient with mixed infection were enrolled. The PCR corrected cumulative risk of recurrent parasitaemia on day 42 was 3.8% (95% CI 1.2–11.2%) in the Pf-noPQ arm compared to 0.9% (95% CI 0.1–6.0%) in the Pf-PQ1 arm; (HR = 0.25 [95% CI 0.03–2.38], p = 0.189). The corresponding risks of recurrence were 13.4% (95% CI 5.2–31.9%) in the Pv-noPQ arm and 5.3% (95% CI 1.3–19.4%) in the Pv-PQ14 arm (HR 0.36 [95% CI 0.1–2.0], p = 0.212). Two (0.9%) patients had G6PD enzyme activity below 10%, 19 (8.9%) patients below 60% of the adjusted male median. Correlation between spectrophotometry and Biosensor™ was low (rs = 0.330, p < 0.001).ConclusionAS/SP remains effective for the treatment of P. falciparum and P. vivax. The addition of PQ reduced the risk of recurrent P. falciparum and P. vivax by day 42, although this did not reach statistical significance. The version of the Biosensor™ assessed is not suitable for routine use.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02592408
Highlights
First-line schizontocidal treatment for uncomplicated malaria in the Republic of the Sudan is artesunate plus Sulphadoxine/pyrimethamine (25/1.25 mg/kg) (AS/SP)
There has been a decline in the incidence of malaria in many sub-Saharan countries in the last decade [1,2,3], which has been attributed to the introduction of artemisinin-based combination therapy (ACT), the scaling up of the distribution of insecticide-impregnated bed nets (ITNs) and indoor residual spraying (IRS) [4]
In addition primaquine (PQ) is prescribed as a 14 day regimen for the radical cure of P. vivax hypnozoites following World Health Organization (WHO) guidelines [12, 13]; a single dose PQ is not currently recommended for patients with P. falciparum as gametocytocidal [14]
Summary
First-line schizontocidal treatment for uncomplicated malaria in the Republic of the Sudan is artesunate (total dose 12 mg/kg) plus Sulphadoxine/pyrimethamine (25/1.25 mg/kg) (AS/SP). The WHO estimates are lower but highlight a substantial decline between 2000 and 2015, cases falling from 4 million cases in 2000–586,827 cases in 2015, with a total of 868 deaths [4]. These successes have been associated with an increase in the proportion of infections due to Plasmodium vivax [6]. This rise likely reflects malaria control activities mostly targeting Plasmodium falciparum [7], and possibly an increased importation of vivax cases from neighbouring countries [6, 8, 9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
