Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-02-29

Brief Summary

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Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria infection, clinical illness and death. By the time they reach school, many children have already acquired some clinical immunity and the ability to limit parasite growth, and thus most infections are asymptomatic and will go undetected and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage may bring education, as well as health, benefits.

Intermittent parasite clearance (IPC) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes, and may usefully supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a policy of universal coverage of nets.

This study seeks to establish whether intermittent parasite clearance undertaken once a year at the end of the malaria transmission season can reduce malaria parasite carriage and anaemia amongst school-going children already using insecticide-treated nets, and its consequent impact on school attendance and performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes in areas of seasonal malaria transmission.

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Detailed Description

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Conditions

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Malaria Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intermittent parasite clearance

Children sleeping under a long-lasting insecticidal net (LLIN) receive an additional intermittent preventive treatment for clearance of asymptomatic malaria infection given once a year at the end of the malaria transmission season

Group Type ACTIVE_COMPARATOR

Intermittent parasite clearance

Intervention Type DRUG

Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days

Control

Children sleeping under a long-lasting insecticidal net (LLIN) receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days

Interventions

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Intermittent parasite clearance

Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days

Intervention Type DRUG

Placebo

Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* enrolled in participating elementary schooled
* provision of parental consent

Exclusion Criteria

* lack of consent
* chronic conditions which limit regular school attendance
* clinical malaria on the day of scheduled treatment (as defined as febrile, with a positive result in a rapid diagnostic test for malaria).

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes