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Clinical Trials/NCT01454752
NCT01454752
Completed
Not Applicable

Intermittent Parasite Clearance (IPC) in Schools: a Randomised Double-blind Placebo-controlled Trial of the Impact of IPC on Malaria, Anaemia and Cognition Amongst School Children in Kedougou, Senegal

London School of Hygiene and Tropical Medicine1 site in 1 country860 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Intermittent parasite clearance
Conditions
Malaria
Sponsor
London School of Hygiene and Tropical Medicine
Enrollment
860
Locations
1
Primary Endpoint
Prevalence of malaria parasitaemia
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
February 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Arms & Interventions

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

Intervention: Intermittent parasite clearance

Control

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

Intervention: Placebo

Outcomes

Primary Outcomes

Prevalence of malaria parasitaemia

Time Frame: 8 weeks after treatment (February 2012)

Prevalence of anaemia (Haemoglobin<11 g/dL)

Time Frame: 8 weeks after treatment (February 2012)

Secondary Outcomes

  • Cognitive performance in tests of sustained attention(8 weeks after treatment (February 2012))

Study Sites (1)

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