Table 1 Characteristics of five trials of IPT in schoolchildren

Country and enrolment period

Kenya (Bondo), March 2005–March 2006

Mali (Kambila), July 2002–July 2003

Mali (Kollé), September 2007–January 2008

Uganda (Tororo), February 2008–July 2008

Uganda (Tororo), February 2011–February 2012

Pattern of transmission

Intense and perennial with seasonal peaks

Seasonal transmission

Seasonal transmission

Entomological inoculation rate in 2001–2002 was 562

high-intensity year-round, estimated entomological inoculation rate of 562

Bed net use

Not available

35.4 %

Study design

Stratified, cluster randomized, double-blind, placebo-controlled

Randomized open controlled

Randomized open placebo-controlled trial

Randomized, single-blinded, placebo-controlled trial

Randomized, double-blind, placebo controlled trial

Number of children based on ITT

740

Randomization

Stratified cluster

Individual

Individual

Individual

Individual

IPTsc drugs and timing of delivery

SP + AQ every 4 months

SP bimonthly

SP + AS and AQ + AS only at baseline

SP, SP + AQ and DP only at baseline

DP monthly and DP every 3 and 5 months

Age of study participants

5–18 years

6 months–10 years

6–13 years

8–12 years for girls and 8–14 years for boys

6–14 years

Follow-up duration

12 months

12 months

11 months

42 days

12 months

Primary endpoint

Prevalence of anaemia

Incidence of clinical malaria

Incidence of clinical malaria and risk of asymptomatic parasitaemia

Risk of asymptomatic parasitaemia at 42 days

Incidence of clinical malaria over 12 months.

Secondary endpoint

School performances

The in vivo response of Plasmodium falciparum to SP

Impact on haemoglobin concentration

Impact on haemoglobin

Parasite prevalence and anemia over 12 months

Control

Dual placebo

Passive surveillance

Placebo

Placebo

Placebo