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Table A Characteristics of infants enrolled in the trial
Characteristics | Placebo (n=1243) | SP (n=1242) |
No (%) male | 608 (49) | 654 (53) |
No (%) rural | 1034 (83) | 1045 (84) |
No (%) bed net use† | 152/921 (17) | 177/924 (19) |
Mean (SD) age (months): | ||
At enrolment | 8.7 (2.7) | 8.6 (2.9) |
At IPTi dose 1 | 13.2 (3.3) | 12.9 (3.2) |
At IPTi dose 2 | 17.9 (4.0) | 17.6 (3.9) |
At IPTi dose 3 | 41.3 (3.4) | 41.2 (3.2) |
At IPTi dose 4 | 54.8 (3.9) | 54.8 (3.9) |
Mean (SD) packed cell volume at IPTi dose 1 | 0.33 (0.04) | 0.33 (0.04) |
Mean (SD) weight (kg) at IPTi dose 1 | 5.6 (0.9) | 5.6 (0.9) |
Mean (SD) height (cm) at IPTi dose 1 | 58.6 (2.9) | 58.5 (2.9) |
IPTi=intermittent preventive treatment for malaria in infants; SP= sulfadoxine-pyrimethamine.
†Data on net use missing for 322 infants in placebo group and 318 in SP group.
Table B Effect on mean packed cell volume (PCV) and prevalence of parasitaemia determined by active surveillance
Approximate age at survey (months) | Mean (SD) % PCV | Parasitaemia (%) | |||||
Placebo | SP | P value | Placebo | SP | P value | ||
3 | 32.7 (4.0) | 32.9 (4.1) | 0.110 | 10.1 | 10.2 | 0.947 | |
9 | 31.3 (4.3) | 31.6 (4.0) | 0.101 | 24.5 | 20.6 | 0.033 | |
12 | 31.1 (4.3) | 31.5 (4.4) | 0.014 | 26.5 | 20.6 | 0.001 | |
18 | 31.4 (4.2) | 31.0 (4.2) | 0.058 | 31.5 | 25.7 | 0.004 | |
SP=sulfadoxine-pyrimethamine.
Table C Adverse events and serious adverse events after IPTi administration
Outcomes | Placebo | SP | Odds ratio (95% CI) | |||||
Events | PYAR | Rate/1000 | Events | PYAR | Rate/1000 | |||
Outpatient attendance | ||||||||
1 month after dose 1 | 300 | 88.4 | 3394.3 | 246 | 90.2 | 2728.7 | 0.80 (0.68 to 0.96) | |
1 month after dose 2 | 313 | 91.8 | 3410.3 | 309 | 92.1 | 3355.9 | 0.98 (0.83 to 1.15) | |
1 month after dose 3 | 323 | 82.8 | 3902.3 | 234 | 85.2 | 2745.7 | 0.71 (0.59 to 0.84) | |
1 month after dose 4 | 262 | 85.3 | 3073.1 | 225 | 86.7 | 2595.0 | 0.85 (0.71 to 1.01) | |
All cause hospital admissions | ||||||||
1 month after dose 1 | 21 | 88.4 | 237.6 | 14 | 90.2 | 155.3 | 0.65 (0.31 to 1.35) | |
1 month after dose 2 | 22 | 91.8 | 239.7 | 21 | 92.1 | 228.1 | 0.95 (0.50 to 1.80) | |
1 month after dose 3 | 35 | 82.8 | 422.9 | 15 | 85.2 | 176.0 | 0.42 (0.21 to 0.79) | |
1 month after dose 4 | 37 | 85.3 | 434.0 | 13 | 86.7 | 150.0 | 0.35 (0.17 to 0.67) | |
IPTi=intermittent preventive treatment for malaria in infants; PYAR=person years at risk; SP=sulfadoxine-pyrimethamine.