Table 3.
Clinical and parasitologic response at Day 28 in studies A0661120 (India), A0661126 (Colombia/Suriname), and A0661154 (Colombia/India)
| India (A0661120)
|
Colombia/Suriname (A0661126)
|
Colombia/India (A0661154)
|
|||||
|---|---|---|---|---|---|---|---|
| AZCQ 1 g | AZCQ 500 mg | SPCQ | AZCQ 1 g | AZCQ 500 mg | AP | AZCQ 2 g | |
| Randomized, n | 83 | 67 | 780 | 114 | 14 | 116 | 110 |
| Cleared/evaluable, n (%) | 61/73 (84) | 39/59 (66) | 68/72 (94) | 66/112 (59) | 4/11 (36) | 112/113 (99) | 104/107 (97) |
| AZCQ 500 mg – comparator; difference, % (95% CI) | −28.3 (−43.5, −13.2) | NAa | NA | ||||
| AZCQ 1 g – comparator; difference, % (95% CI) | −10.9 (−22.6, 0.8) | −42.0 (−52.2, 31.7) | NA | ||||
| ETF, n (%) | 6 (8) | 6 (10) | 1 (1) | 12 (11) | 1 (1) | 0 | |
| LTF, n (%) | 6 (8) | 14 (24) | 3 (4) | 37 (33) | 1 (1) | 3 (3) | |
| LPF (Day 28), n | 3 | 8 | 2 | 27 | 0 | 1 | |
| LCF (Day 28), n | 2 | 6 | 1 | 10 | 0 | 2 | |
Note:
a
Statistical comparison between 500 mg AZCQ and AP was not performed due to the decision to discontinue the AZCQ 500 mg arm.
Abbreviations: AP, atovaquone–proguanil; AZCQ, azithromycin–chloroquine; CI, confidence interval; ETF, early treatment failure; LCF, late clinical failure; LPF, late parasitological failure; LTF, late treatment failure; NA, not applicable; SPCQ, chloroquine plus sulfadoxine–pyrimethamine.