NCT00142246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,758

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

August 31, 2005

Last Update Submit

January 25, 2017

Conditions

Malaria, Falciparum

Keywords

malariaanaemiaschool performanceeducationintermittent preventive treatmentschools

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anaemia (Hb <112g/L)

    March 2006

Secondary Outcomes (3)

  • Prevalence of Plasmodium falciparum parasitaemia

    March 2006

  • Sustained attention

    March 2006

  • Mean haemoglobin

    March 2006

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Intermittent preventive treatment (SP and amodiaquine)

2

PLACEBO COMPARATOR

Dual placebo comparator

Other: Placebo

Interventions

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.

1
PlaceboOTHER

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

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary schools within Bondo district / Bondo District Hospital

Bondo, Bondo District, Kenya

Location

Related Publications (3)

  • 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.

    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.

    PMID: 18620950DERIVED

MeSH Terms

Conditions

Malaria, FalciparumMalariaAnemia

Interventions

Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

KE(1)