School Based Malaria Control in Ugandan Schoolchildren (SBMC)

Makerere University

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP); Drug: Monthly IPT using DP; Drug: Placebo given every month

Study type: Interventional

Funder types: Other

Identifiers

NCT01231880

MCDC-SBMC

Details and patient eligibility

About

The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.

Enrollment: 740 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 6 - 14 years
• Pupils enrolled at participating school
• Willingness of the parent/guardian to provide consent
• Provision of assent by pupil (those above 8 years)

Exclusion criteria

• Known allergy or history of adverse reaction to study medications
• Intention of changing of schools during the follow-up period
• History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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740 participants in 3 patient groups, including a placebo group

Four monthly IPT

Experimental group

Description:

IPT give once a school term (every four months)

Treatment:

Drug: Four monthly IPT with dihydroartemisinin Piperaquine (DP)

Monthly IPT

Experimental group

Description:

IPT given every month

Treatment:

Drug: Monthly IPT using DP

Placebo

Placebo Comparator group

Description:

No active drug in the placebo

Treatment:

Drug: Placebo given every month