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

Primary Purpose

Malaria, Anaemia

Status
Completed
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Intermittent parasite clearance
Placebo
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring malaria, anaemia, cognition, intermittent preventive treatment, children, schools, insecticide-treated nets

Eligibility Criteria

7 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Institut de Recherche pour le Developpement

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intermittent parasite clearance

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Prevalence of malaria parasitaemia
Prevalence of anaemia (Haemoglobin<11 g/dL)

Secondary Outcome Measures

Cognitive performance in tests of sustained attention

Full Information

First Posted
October 12, 2011
Last Updated
April 18, 2012
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Division Controle Medicale Scolaire, Ministry of Education, Senegal, Ministry of Health, Senegal, Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal, Cheikh Anta Diop University, Senegal, Institut de Recherche pour le Developpement, Senegal, Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT01454752
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Division Controle Medicale Scolaire, Ministry of Education, Senegal, Ministry of Health, Senegal, Institut National d'Etude et d'Action pour le Developpement de l'Education, Senegal, Cheikh Anta Diop University, Senegal, Institut de Recherche pour le Developpement, Senegal, Harvard University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Anaemia
Keywords
malaria, anaemia, cognition, intermittent preventive treatment, children, schools, insecticide-treated nets

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
860 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent parasite clearance
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Children sleeping under a long-lasting insecticidal net (LLIN) receive placebo
Intervention Type
Drug
Intervention Name(s)
Intermittent parasite clearance
Intervention Description
Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days
Primary Outcome Measure Information:
Title
Prevalence of malaria parasitaemia
Time Frame
8 weeks after treatment (February 2012)
Title
Prevalence of anaemia (Haemoglobin<11 g/dL)
Time Frame
8 weeks after treatment (February 2012)
Secondary Outcome Measure Information:
Title
Cognitive performance in tests of sustained attention
Time Frame
8 weeks after treatment (February 2012)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sian E Clarke, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recherche pour le Developpement
City
Dakar
Country
Senegal

12. IPD Sharing Statement

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

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