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

NCT01454752 | Completed

• 1 other identifier: WT-Clarke-Sen2011
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Anaemia

Keywords

malaria; anaemia; cognition; intermittent preventive treatment; children; schools; insecticide-treated nets

Outcome Measures

Primary Outcomes (2)

• Prevalence of malaria parasitaemia

  8 weeks after treatment (February 2012)

• Prevalence of anaemia (Haemoglobin<11 g/dL)

  8 weeks after treatment (February 2012)

Secondary Outcomes (1)

• Cognitive performance in tests of sustained attention

  8 weeks after treatment (February 2012)

Study Arms (2)

Intermittent parasite clearance

ACTIVE COMPARATOR

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

Drug: Intermittent parasite clearance

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Intermittent parasite clearance

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• enrolled in participating elementary schooled
• provision of parental consent

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Institut de Recherche pour le Developpement

Dakar, Senegal

Location

MeSH Terms

Conditions

Malaria; Anemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sian E Clarke, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

SE (1)