Table 1 |
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|
Clinical studies evaluating the efficacy and safety of the six-dose regimen of artemether/lumefantrine |
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| Study number |
A025 [10] |
A026[11] |
A028[12] |
A2403[13] |
B2303[14] |
A2401[15] |
|
|
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| 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 |
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| Nigeria |
Mali |
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| Benin |
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| Mozambique |
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| 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) |
|
|
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|
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. |
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|
Makanga and Krudsood Malaria Journal 2009 8(Suppl 1):S5 doi:10.1186/1475-2875-8-S1-S5 |
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