Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| Senegal | |
| Institut de Recherche pour le Developpement | |
| Dakar, Senegal | |
| 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 May 23, 2013