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

Primary Purpose

Malaria, Falciparum

Status
Completed
Phase
Phase 3
Locations
Kenya
Study Type
Interventional
Intervention
Intermittent preventive treatment (SP and amodiaquine)
Placebo
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria, Falciparum focused on measuring malaria, anaemia, school performance, education, intermittent preventive treatment, schools

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Primary schools within Bondo district / Bondo District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

Dual placebo comparator

Outcomes

Primary Outcome Measures

Prevalence of anaemia (Hb <112g/L)

Secondary Outcome Measures

Prevalence of Plasmodium falciparum parasitaemia
Sustained attention
Mean haemoglobin

Full Information

First Posted
August 31, 2005
Last Updated
January 25, 2017
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Nairobi
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1. Study Identification

Unique Protocol Identification Number
NCT00142246
Brief Title
Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Nairobi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
malaria, anaemia, school performance, education, intermittent preventive treatment, schools

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6758 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Dual placebo comparator
Intervention Type
Drug
Intervention Name(s)
Intermittent preventive treatment (SP and amodiaquine)
Intervention Description
Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age
Primary Outcome Measure Information:
Title
Prevalence of anaemia (Hb <112g/L)
Time Frame
March 2006
Secondary Outcome Measure Information:
Title
Prevalence of Plasmodium falciparum parasitaemia
Time Frame
March 2006
Title
Sustained attention
Time Frame
March 2006
Title
Mean haemoglobin
Time Frame
March 2006

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sian E Clarke, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine, University of London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon J Brooker, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine, University of London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benson BA Estambale, MBChB, PhD
Organizational Affiliation
University of Nairobi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew CH Jukes, PhD
Organizational Affiliation
Partnership for Child Development, Imperial College, University of London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Magnussen, MD
Organizational Affiliation
DBL - Institute for Health Research and Development, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary schools within Bondo district / Bondo District Hospital
City
Bondo
State/Province
Bondo district
Country
Kenya

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18620950
Citation
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. Erratum In: Lancet. 2009 Jan 3;373(9657):30.
Results Reference
derived

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

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