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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454752
• Other study ID #: WT-Clarke-Sen2011
• Status: Completed
• Phase: N/A
• First received: October 12, 2011
• Last updated: April 18, 2012
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Malaria

Intervention

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

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

Locations

Country	Name	City	State
Senegal	Institut de Recherche pour le Developpement	Dakar

Sponsors (7)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Cheikh Anta Diop University, Senegal, Division Controle Medicale Scolaire, Ministry of Education, Senegal, Harvard University, Institut de Recherche pour le Developpement, Senegal, Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal, Ministry of Health, Senegal

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of malaria parasitaemia		8 weeks after treatment (February 2012)	No
Primary	Prevalence of anaemia (Haemoglobin<11 g/dL)		8 weeks after treatment (February 2012)	No
Secondary	Cognitive performance in tests of sustained attention		8 weeks after treatment (February 2012)	No