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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
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

October 12, 2011
April 18, 2012
November 2011
February 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Prevalence of malaria parasitaemia [ Time Frame: 8 weeks after treatment (January 2012) ] [ Designated as safety issue: No ]
  • Prevalence of anaemia (Haemoglobin<11 g/dL) [ Time Frame: 8 weeks after treatment (January 2012) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01454752 on ClinicalTrials.gov Archive Site
Cognitive performance in tests of sustained attention [ Time Frame: 8 weeks after treatment (February 2012) ] [ Designated as safety issue: No ]
Cognitive performance in tests of sustained attention [ Time Frame: 8 weeks after treatment (January 2012) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Malaria
  • Anaemia
  • 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
  • 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
    Intervention: Drug: Intermittent parasite clearance
  • Placebo Comparator: Control
    Children sleeping under a long-lasting insecticidal net (LLIN) receive placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
860
February 2012
February 2012   (final data collection date for primary outcome measure)

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).
Both
7 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Senegal
 
NCT01454752
WT-Clarke-Sen2011
No
London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • 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
Principal Investigator: Sian E Clarke, PhD London School of Hygiene and Tropical Medicine, UK
London School of Hygiene and Tropical Medicine
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP