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

This study has been completed.
Sponsor:
Collaborators:
Division Controle Medicale Scolaire, Ministry of Education, Senegal
Programme National de Lutte contre le Paludisme, 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
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01454752
First received: October 12, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Malaria
Anaemia
Drug: Intermittent parasite clearance
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Prevalence of malaria parasitaemia [ Time Frame: 8 weeks after treatment (February 2012) ] [ Designated as safety issue: No ]
  • Prevalence of anaemia (Haemoglobin<11 g/dL) [ Time Frame: 8 weeks after treatment (February 2012) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive performance in tests of sustained attention [ Time Frame: 8 weeks after treatment (February 2012) ] [ Designated as safety issue: No ]

Enrollment: 860
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intermittent parasite clearance
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
Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days
Placebo Comparator: Control
Children sleeping under a long-lasting insecticidal net (LLIN) receive placebo
Other: Placebo
Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454752

Locations
Senegal
Institut de Recherche pour le Developpement
Dakar, Senegal
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Division Controle Medicale Scolaire, Ministry of Education, Senegal
Programme National de Lutte contre le Paludisme, 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
Investigators
Principal Investigator: Sian E Clarke, PhD London School of Hygiene and Tropical Medicine, UK
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01454752     History of Changes
Other Study ID Numbers: WT-Clarke-Sen2011
Study First Received: October 12, 2011
Last Updated: April 18, 2012
Health Authority: Senegal: Ministere de la sante

Keywords provided by London School of Hygiene and Tropical Medicine:
malaria
anaemia
cognition
intermittent preventive treatment
children
schools
insecticide-treated nets

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 20, 2014