Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 3

Conditions: Malaria, Falciparum

Treatments: Other: Placebo; Drug: Intermittent preventive treatment (SP and amodiaquine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00142246

ITDCVG41

Details and patient eligibility

About

This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.

Full description

Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding & Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes.

The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated.

The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class.

Schools are randomly allocated to one of two arms:

• Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics
• Control schools: mass treatment with anthelminthics only

Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.

Enrollment: 6,758 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in primary school, and attending regularly
• Enrolled in nursery or classes 1-7
• Informed consent from parent or guardian

Exclusion criteria

• Enrolled in primary class 8
• Haemoglobin level below 70g/L at baseline
• History of reaction to sulfa drugs (e.g. fansidar, septrin)
• History of severe skin reaction to any drug

Withdrawal criteria:

• Withdrawal of parental consent
• Haemoglobin level falling below 70g/L
• Severe adverse reaction to treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,758 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)

Treatment:

Drug: Intermittent preventive treatment (SP and amodiaquine)

2

Placebo Comparator group

Description:

Dual placebo comparator

Treatment:

Other: Placebo