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| Sponsors and Collaborators: |
Gates Malaria Partnership University of Nairobi |
|---|---|
| Information provided by: | Gates Malaria Partnership |
| ClinicalTrials.gov Identifier: | NCT00142246 |
Purpose
This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Falciparum |
Drug: Intermittent preventive treatment (SP and amodiaquine) Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya |
| Enrollment: | 6758 |
| Study Start Date: | January 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)
|
Drug: Intermittent preventive treatment (SP and amodiaquine)
Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.
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2: Placebo Comparator
Dual placebo comparator
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Other: Placebo
Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age
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Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding & Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes.
The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated.
The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class.
Schools are randomly allocated to one of two arms:
Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
Contacts and Locations| Kenya, Bondo district | |
| Primary schools within Bondo district / Bondo District Hospital | |
| Bondo, Bondo district, Kenya | |
| Principal Investigator: | Sian E Clarke, PhD | London School of Hygiene and Tropical Medicine, University of London, UK |
| Principal Investigator: | Simon J Brooker, PhD | London School of Hygiene and Tropical Medicine, University of London, UK |
| Principal Investigator: | Benson BA Estambale, MBChB, PhD | University of Nairobi |
| Principal Investigator: | Matthew CH Jukes, PhD | Partnership for Child Development, Imperial College, University of London, UK |
| Principal Investigator: | Pascal Magnussen, MD | DBL - Institute for Health Research and Development, Denmark |
More Information
| Study ID Numbers: | ITDCVG41 |
| Study First Received: | August 31, 2005 |
| Last Updated: | February 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00142246 |
| Health Authority: | Kenya: Ministry of Health |
|
malaria anaemia school performance |
education intermittent preventive treatment schools |
|
Protozoan Infections Amodiaquine Anemia |
Parasitic Diseases Malaria Malaria, Falciparum |
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Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Pharmacologic Actions |
