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| Name | Class |
|---|---|
| University of Nairobi | OTHER |
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This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine) |
|
| 2 | Placebo Comparator | Dual placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent preventive treatment (SP and amodiaquine) | Drug | Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of anaemia (Hb <112g/L) | March 2006 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Plasmodium falciparum parasitaemia | March 2006 | |
| Sustained attention | March 2006 | |
| Mean haemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary schools within Bondo district / Bondo District Hospital | Bondo | Bondo District | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Clarke SE, Brooker S, Jukes MCH, Njagi JK, Khasakhala L, Otido J, Crudder C, McGlone B, Magnussen P & Estambale BBA. (2006). Randomised controlled trial of intermittent preventive treatment in schoolchildren: Impact on malaria, anaemia & school performance [abstract]. American Journal of Tropical Medicine & Hygiene Suppl 75 (5): 123. | ||
| Background | Clarke S, Njagi J, Jukes M, Estambale B, Khasakhala L, Ajanga A, Luoba A, Otido J, Ochola S & Magnussen P. (2005). Intermittent preventive treatment in schools: Malaria parasitaemia, anaemia and school performance [abstract]. Acta Tropica, Suppl 95: S133. | ||
| 18620950 | Derived | Clarke SE, Jukes MC, Njagi JK, Khasakhala L, Cundill B, Otido J, Crudder C, Estambale BB, Brooker S. Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jul 12;372(9633):127-138. doi: 10.1016/S0140-6736(08)61034-X. |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D000655 | Amodiaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Other | Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age |
|
| March 2006 |
| D000079426 |
| Vector Borne Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006571 | Heterocyclic Compounds |