Abstract:
Objective To evaluate the effects of intermittent
preventive treatment for malaria in infants (IPTi) with
sulfadoxine-pyrimethamine in an area of intense,
seasonal transmission.
Design Cluster randomised placebo controlled trial,
with 96 clusters allocated randomly to
sulfadoxine-pyrimethamine or placebo in blocks of
eight.
Interventions Children received
sulfadoxine-pyrimethamine or placebo and one
month of iron supplementation when they received
DPT-2, DPT-3, or measles vaccinations and at 12
months of age.
Main outcome measures Incidence of malaria and of
anaemia determined through passive case detection.
Results 89% (1103/1242) of children in the placebo
group and 88% (1088/1243) in the IPTi group
completed follow-up to 24 months of age. The
protective efficacy of IPTi against all episodes of
malaria was 24.8% (95% confidence interval 14.3% to
34.0%) up to 15 months of age. IPTi had no
protective effect against malaria between 16 and 24
months of age (protective efficacy –4.9%, − 21.3% to
9.3%). The incidence of high parasite density malaria
( ≥ 5000 parasites/ l) was higher in the IPTi group
than in the placebo group between 16 and 24 months
of age (protective efficacy − 19.5%, − 39.8% to
− 2.2%). IPTi reduced hospital admissions with
anaemia by 35.1% (10.5% to 52.9%) up to 15 months
of age. IPTi had no significant effect on anaemia
between 16 and 24 months of age (protective efficacy
− 6.4%, − 76.8% to 35.9%). The relative risk of death
up to 15 months of age in the IPTi group was 1.26
(95% confidence interval 0.81 to 1.96; P = 0.31), and
from 16 to 24 months it was 1.28 (0.77 to 2.14;
P = 0.35).
Conclusions Intermittent preventive treatment for
malaria with sulfadoxine-pyrimethamine can reduce
malaria and anaemia in infants even in seasonal, high
transmission areas, but concern exists about possible
