Table 1.
Characteristics of studies included in pooled analysis for patients treated for uncomplicated Plasmodium falciparum malaria*
| Characteristic | Study and reference | ||||||
|---|---|---|---|---|---|---|---|
| A02519 | A02626 | A02827 | A240136 | A240333 | B230334 | A241235 | |
| Design | Randomized, double-blind, multicenter | Randomized, open-label, multicenter | Randomized, open-label, multicenter | Single-arm, open- label, multicenter | Single-arm, multicenter | Randomized, investigator-blinded, multicenter | Randomized, open-label, single-center |
| Comparators | 4-dose AL | Mefloquine plus artesunate | Mefloquine plus artesunate | – | – | Dispersible AL tablets | Mefloquine plus artesunate, atovaquone plus proguanil |
| Location | Thailand | Thailand | Thailand | European Union and Colombia† | Africa‡ | Africa§ | Thailand |
| Time period | 1996–1997 | 1997–1998 | 1998–1999 | 2001–2005 | 2002–2003 | 2006–2007 | 2005 |
| Inclusion criteria | |||||||
| Age, years | ≥ 2 | ≥ 2 | > 12 | > 2, ≥ 18 post-amendment | <10 | ≤ 12 | > |
| Body weight, kg | Not specified | Not specified | ≥ 35 | Not specified | 5–25 | 5–< 35 | Not specified |
| Fever | Not specified | Not specified | Not specified | Not specified | ≥ 37.5°C | ≥ 37.5°C axillary or ≥ 38°C rectally or history of fever in previous 24 hours | ≥ 37.5°C |
| Microscopic confirmation of P. falciparum infection | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| P. falciparum density/μL | > 500 | > 500 | Not specified | Not specified | 1,000–< 100,000 | 2,000–< 200,000 | 50–< 100,000 |
| AL dosing | |||||||
| AL dosing | Supervised | Supervised | Not specified | Not specified | Supervised | Supervised | Supervised |
| Concomitant food/milk | Not specified | Recommended | Recommended | Recommended | Recommended | Recommended | Recommended |
| Patients included in study populations | |||||||
| Adult mITT population (n = 599) | 180 | 108 | 149 | 162 | – | – | – |
| Adult safety population (n = 647) | 180 | 109 | 149 | 165 | – | – | 44 |
| Children mITT population (n = 877) | 59 | 41 | 15 | – | 310 | 452¶ | - |
| Children safety population (n = 1,332) | 59 | 41 | 15 | – | 310 | 899¶ | 8 |
*
AL = artemether-lumefantrine; mITT = modified intent-to-treat.
†
Non-immune travelers.
‡
Kenya, Nigeria, and Tanzania.
§
Benin, Kenya, Mali, Mozambique, and Tanzania.
¶
Patients receiving the dispersible formulation of AL were only included in the safety population.