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Table 1 Clinical studies evaluating the efficacy and safety of the six-dose regimen of artemether/lumefantrine

From: The clinical efficacy of artemether/lumefantrine (Coartem®)

Study number A025[10] A026[11] A028[12] A2403[13] B2303[14] A2401[15]
Design Randomized double-blind Randomized open-label Randomized open-label Open-label Randomized investigator blind Open-label
Comparator Four-dose regimen MASa MASa - Dispersible formulation -
Patients Adults & children (>2 years) Adults & children (≥ 2 years) Adults & adolescents (>12 years) Infants & children (5 to 25 kg) Infants & children (5 to <35 kg) Adult non-immune travellers
N AL/total Geography 120/359b 150/200 164/219 310 452/899 165
  Thailand Thailand Thailand Kenya Kenya EU
     Tanzania Tanzania Colombia
     Nigeria Mali  
      Benin  
      Mozambique  
28-day PCR-corrected cure rate (evaluable pts) 96.9% 97.7% 95.5% 96.7% 97.8% 96.0%
Median time to fever clearance (h) (mITT popn) 35 (n = 59) 22 (n = 87) 29 (n = 76) 7.8 (n = 309) 7.8 (n = 311) 36.5 (n = 100)
Median time to parasite clearance (h) (mITT popn) 43.6 (n = 118) 48 (n = 149) 29.3 (n = 164) 24.0 (n = 310) 34.9 (n = 452) 41.8 (n = 162)
  1. aStudy was not designed to compare AL with mefloquine + artesunate; bAL over 60 hours; c28-day cure rate was a secondary endpoint. Abbreviations: AL, artemether/lumefantrine; MAS, mefloquine + artesunate.