Table 4. Comparison of primary and key secondary outcomes during the post intervention period dry season 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 | 57 | 467.6 | 64 | 466.4 | 0.3 (−178.9 to 34.9) | 0.422 | 47 | 362.8 | 22.4 (−124.2 to 50.6) | 0.885 | 76 | 516.4 | −10.4 (−301.7 to −4.3) | 0.037 |
Malaria with any parasitaemia | 10 | 3.7 | 14 | 5.0 | −35.1 (−237.3 to 14.4) | 0.870 | 15 | 5.8 | −56.8 (−201.6 to 27.3) | 0.720 | 7 | 2.5 | 32.4 (−125.9 to 55.8) | 0.257 |
Malaria with high density (>7000 parasites /µl) | 8 | 2.7 | 13 | 4.6 | −70.0 (−574.9 to −4.6) | 0.961 | 9 | 3.5 | −29.6 (−395.5 to 15.4) | 0.888 | 6 | 2.1 | 3.2 (−226.8 to 48.5) | 0.435 |
Anaemia (Hb<8.0 g/dl) | 9 | 4.6 | 6 | 3.5 | 23.4 (−105.6 to 75.4) | 0.472 | 5 | 3.2 | 30.4 (−125.1 to 76.0) | 0.410 | 3 | 1.6 | 65.2 (−263.0 to 91.0) | 0.893 |
Malaria anaemia | 7 | 2.4 | 5 | 1.8 | 25.0 (−133.1 to 77.2) | 0.407 | 6 | 2.3 | 4.2 (−169.8 to 71.0) | 0.171 | 3 | 1.1 | 54.4 (−606.0 to 89.5) | 0.799 |
All cause admissions | 3 | 2.3 | 3 | 2.5 | −6.4 (−107.1 to 90.3) | 0.961 | 6 | 2.7 | −15.8 (−442.5 to 97.7) | 0.938 | 5 | 2.4 | − 3.8 (−155.9 to 93.5) | 0.979 |
Malaria admissions | 2 | 1.56 | 2 | 1.66 | −6.4 (−159.8 to 93.4) | 0.996 | 3 | 1.35 | 13.5 (−174.9 to 92.8) | 0.918 | 2 | 0.97 | 37.8 (−513.3 to 97.9) | 0.985 |
PE: protective efficacy = (1−rate ratio)*100; rate ratio was ¶adjusted for age at enrolment and bednet use