Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.

NCT ID: NCT00142246

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6758 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-04-30

Brief Summary

This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.

Detailed Description

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:

• Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics
• Control schools: mass treatment with anthelminthics only

Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.

Conditions

Malaria, Falciparum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)

Group Type: EXPERIMENTAL

Intermittent preventive treatment (SP and amodiaquine)

Intervention Type: DRUG

Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.

2

Dual placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age

Interventions

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.

Intervention Type: DRUG

Placebo

Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Enrolled in primary school, and attending regularly
• Enrolled in nursery or classes 1-7
• Informed consent from parent or guardian

Exclusion Criteria

• Enrolled in primary class 8
• Haemoglobin level below 70g/L at baseline
• History of reaction to sulfa drugs (e.g. fansidar, septrin)
• History of severe skin reaction to any drug

Withdrawal criteria:

• Withdrawal of parental consent
• Haemoglobin level falling below 70g/L
• Severe adverse reaction to treatment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nairobi

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Brian Greenwood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sian E Clarke, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine, University of London, UK

Simon J Brooker, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine, University of London, UK

Benson BA Estambale, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nairobi

Matthew CH Jukes, PhD

Role: PRINCIPAL_INVESTIGATOR

Partnership for Child Development, Imperial College, University of London, UK

Pascal Magnussen, MD

Role: PRINCIPAL_INVESTIGATOR

DBL - Institute for Health Research and Development, Denmark

Locations

Primary schools within Bondo district / Bondo District Hospital

Bondo, Bondo District, Kenya

Countries

Kenya

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 18620950 (View on PubMed)

Other Identifiers

ITDCVG41

Identifier Type: -

Identifier Source: org_study_id