Table 2. Comparison of primary and key secondary outcomes during the six-month intervention period between study groups.
Outcomes | Placebo¶ | SP bimonthly¶ | AS+AQ bimonthly¶ | AS+AQ monthly¶ | ||||||||||
Episodes | Rate* | Episodes | Rate* | PE (95% CI) | p-value | Episodes | Rate* | PE (95% CI) | p-value | Episodes | Rate* | PE (95% CI) | p-value | |
Total OPD attendance | 684 | 1053.8 | 554 | 974.1 | 1.0 (−6.3 to 7.8) | 0.782 | 556 | 1003.9 | 3.0 (−10.5 to 4.1) | 0.420 | 497 | 911.8 | 4.9 (−2.3 to 11.6) | 0.180 |
Malaria with any parasitaemia | 183 | 394.4 | 112 | 267.9 | 24.3 (14.1 to 33.4) | <0.001 | 109 | 282.1 | 17.4 (6.3 to 27.2) | 0.003 | 44 | 104.0 | 69.1 (62.9 to 74.2) | <0.001 |
Malaria with high density (>7000 parasites /µl) | 137 | 297.7 | 80 | 181.6 | 31.0 (19.7 to 40.8) | <0.001 | 77 | 208.9 | 20.4 (7.8 to 31.4) | 0.002 | 34 | 73.6 | 70.9 (64.0 to 76.5) | <0.001 |
Anaemia (Hb<8.0 g/dl) | 64 | 151.2 | 33 | 82.1 | 30.8 (6.4 to 48.9) | 0.017 | 42 | 113.7 | 31.7 (7.0 to49.8) | 0.016 | 26 | 63.4 | 45.3 (24.7 to 60.3) | <0.001 |
Malaria anaemia | 20 | 10.2 | 15 | 6.1 | 36.2 (−16.7 to 65.2) | 0.145 | 14 | 7.0 | 26.7 (−33.0 to 59.6) | 0.307 | 2 | 1.7 | 82.1 (53.7 to 93.1) | <0.001 |
All cause admissions | 25 | 2.4 | 18 | 2.8 | −16.7 (−142 to 39.9) | 0.598 | 9 | 2.7 | −12.5 (−194 to 66.9) | 0.980 | 10 | 2.4 | 0.0 (−222.0 to 53.7) | 0.687 |
Malaria admissions | 19 | 1.9 | 11 | 1.7 | 7.4 (−199 to 71.4) | 0.898 | 7 | 2.1 | −10.5 (−815 to 55.9) | 0.368 | 7 | 1.7 | 15.1 (−281.8 to 81.1) | 0.670 |
PE: protective efficacy = (1−rate ratio)*100; rate ratio was ¶adjusted for age at enrolment and bednet use