We enrolled children if they were ≥6 months and <12 years and presented with acute (≤72 h), uncomplicated falciparum malaria and either a positive malaria slide for P. falciparum (mono or mixed infection) of any parasitaemia or a positive rapid diagnostic test (SD-Bioline Malaria-Ag-Pf/Pan™, SD Bioline, S. Korea), and their legal guardian gave signed informed consent to the main study and the pharmacokinetic substudy.
Using tablet strengths of 2.5, 5, 7.5 mg tablets (Centurion Laboratories, Vadodara, India)], the age-based regimen was dosed as: (i) 6 m–<1 y: 1.25 mg, (ii) 1–5 y: 2.5 mg, (iii) 6–9 y: 5 mg, and 10–11 y: 7.5 mg. AL (Coartem®, Novartis, Switzerland) and DHAPP (D-ARTEPP®, Guilin, China) were dosed by weight, according to WHO recommendations, crushed, dissolved in water and given with milk. Children aged ≥5 years in Mbale were given whole primaquine tablets to swallow. Full and half doses of all study drugs were given again, if vomiting occurred within 30 and 60 min, respectively.
There was no formal sample size calculation for this PK component of the main study; rather this depended on the capacity at each site and we aimed for a PK population of at least 200.
Using tablet strengths of 2.5, 5, 7.5 mg tablets (Centurion Laboratories, Vadodara, India)], the age-based regimen was dosed as: (i) 6 m–<1 y: 1.25 mg, (ii) 1–5 y: 2.5 mg, (iii) 6–9 y: 5 mg, and 10–11 y: 7.5 mg. AL (Coartem®, Novartis, Switzerland) and DHAPP (D-ARTEPP®, Guilin, China) were dosed by weight, according to WHO recommendations, crushed, dissolved in water and given with milk. Children aged ≥5 years in Mbale were given whole primaquine tablets to swallow. Full and half doses of all study drugs were given again, if vomiting occurred within 30 and 60 min, respectively.
There was no formal sample size calculation for this PK component of the main study; rather this depended on the capacity at each site and we aimed for a PK population of at least 200.
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