Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7519.727 (Published 29 September 2005) Cite this as: BMJ 2005;331:727Data supplement
Table A Characteristics of infants enrolled in the trialCharacteristics
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.
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