. "Letter Report." Assessment of the Role of Intermittent Preventive Treatment for Malaria in Infants: Letter Report. Washington, DC: The National Academies Press, 2008.
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Assessment of the Role of Intermittent Preventive Treatment for Malaria in Infants: Letter Report
TABLE 17 Protective Efficacy (PE) and Reported 95% Confidence Intervals (CI) for Outcomes from Randomization Through 11 Months After Last Dose of SP or Placebo
Location, Country
Ifakara, Tanzania
Navrongo, Ghana
Manhiça, Mozambique
Overall
Number of Subjects
Placebo
351
1225
748
IPTi-SP
350
1221
755
Episodes of Clinical Malaria
Placebo
259
1871
576
IPTi-SP
180
1570
564
% PE
32
16
2
17
95 CI (%)
(14, 47)
(4, 26)
(−20, 20)
(0.8, 30)
p-value
0.002
0.007
0.84
0.04
Episodes of Hospitalization with Malaria Parasites
Placebo
71
122
102
IPTi-SP
42
83
108
% PE
42
32
−3
26
95 CI (%)
(12, 62)
(5, 51)
(−56, 32)
(−0.9, 46)
p-value
0.011
0.023
0.89
0.057
Episodes of All-Cause Hospital Admissions
Placebo
226
561
402
IPTi-SP
191
513
379
% PE
16
8
13
12
95 CI (%)
(−6, 34)
(−10, 23)
(−10, 31)
(0.2, 22)
p-value
0.14
0.36
0.25
0.046
Subjects with Anemia
Placebo
52
274
108
IPTi-SP
42
263
119
% PE
23
4
8
9
95 CI (%)
(−11, 47)
(−19, 22)
(−16, 28)
(−6, 21)
p-value
0.16
0.73
0.47
0.22
SOURCE: Compiled from data in the report of the Consortium’s Statistical Working Group (IPTi Consortium, 2008f).
The IOM committee was aware that it had available for deliberations more data and analyses than had been available to other independent committees that had previously assumed the task of reviewing and assessing the efficacy of IPTi-SP. Nevertheless, we were sensitive to the fact that some of the most important analyses we reviewed were from reports that had not yet been published.
Finding about heterogeneity of IPTi-SP studies: The committee found that the six IPTi-SP studies differed in their settings, intensity and seasonality of malaria transmission, use of insecticide-treated bed net coverage, prevalence of SP resistance and age at administration of doses of SP (or of placebo). The committee viewed this heterogeneity as a positive feature of the set of trials, concluding that IPTi-SP has been evaluated in several venues within sub-Saharan Africa that have different conditions, which allows generalizability to other sites in sub-Saharan Africa that have high or moderate intensity of transmission. Analysis of results from the different sites both shows the generalizability of IPTi-SP and identifies limitations that might not be detected if the conditions were more homogeneous.
Conclusion about efficacy data: The committee concluded that the trials had adequate power to assess the effect of IPTi-SP on the number of episodes of clinical malaria.