Clinical trial NCT01454752: Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Anaemia
Keywords: malaria
anaemia
cognition
intermittent preventive treatment
children
schools
insecticide-treated nets
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Division Controle Medicale Scolaire, Ministry of Education, Senegal
name: Ministry of Health, Senegal
name: Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal
name: Cheikh Anta Diop University, Senegal
name: Institut de Recherche pour le Developpement, Senegal
name: Harvard University
First posted: 2011-10-19
Enrollment: 860
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Prevalence of malaria parasitaemia
timeFrame: 8 weeks after treatment (February 2012)
measure: Prevalence of anaemia (Haemoglobin<11 g/dL)
timeFrame: 8 weeks after treatment (February 2012)
Secondary outcomes:
measure: Cognitive performance in tests of sustained attention
timeFrame: 8 weeks after treatment (February 2012)
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Institut de Recherche pour le Developpement
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Sian E Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
References: