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Completed

NCT Number: NCT01454752

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

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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Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche pour le Developpement

Dakar, Senegal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intermittent parasite clearance

Drug

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

Placebo

Other

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

Primary outcomes

  1. Prevalence of malaria parasitaemia

    Time frame: 8 weeks after treatment (February 2012)

  2. Prevalence of anaemia (Haemoglobin<11 g/dL)

    Time frame: 8 weeks after treatment (February 2012)

Secondary outcomes

  1. Cognitive performance in tests of sustained attention

    Time frame: 8 weeks after treatment (February 2012)

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Cheikh Anta Diop University, Senegal
  • Division Controle Medicale Scolaire, Ministry of Education, Senegal
  • Harvard University
  • Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal
  • Institut de Recherche pour le Developpement, Senegal
  • Ministry of Health, Senegal

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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