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) |