Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
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|ClinicalTrials.gov Identifier: NCT01454752|
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : April 19, 2012
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 or disease||Intervention/treatment||Phase|
|Malaria Anaemia||Drug: Intermittent parasite clearance Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||860 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||November 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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
Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days
- Prevalence of malaria parasitaemia [ Time Frame: 8 weeks after treatment (February 2012) ]
- Prevalence of anaemia (Haemoglobin<11 g/dL) [ Time Frame: 8 weeks after treatment (February 2012) ]
- Cognitive performance in tests of sustained attention [ Time Frame: 8 weeks after treatment (February 2012) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454752
|Institut de Recherche pour le Developpement|
|Principal Investigator:||Sian E Clarke, PhD||London School of Hygiene and Tropical Medicine, UK|