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

This study has been completed.
Sponsor:
Collaborator:
University of Nairobi
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00142246
First received: August 31, 2005
Last updated: February 7, 2008
Last verified: February 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Prevalence of anaemia (Hb <112g/L) [ Time Frame: March 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of Plasmodium falciparum parasitaemia [ Time Frame: March 2006 ] [ Designated as safety issue: No ]
  • Sustained attention [ Time Frame: March 2006 ] [ Designated as safety issue: No ]
  • Mean haemoglobin [ Time Frame: March 2006 ] [ Designated as safety issue: No ]

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
Experimental: 1
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.
Placebo Comparator: 2
Dual placebo comparator
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142246

Locations
Kenya
Primary schools within Bondo district / Bondo District Hospital
Bondo, Bondo district, Kenya
Sponsors and Collaborators
Gates Malaria Partnership
University of Nairobi
Investigators
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

Publications:
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00142246     History of Changes
Other Study ID Numbers: ITDCVG41
Study First Received: August 31, 2005
Last Updated: February 7, 2008
Health Authority: Kenya: Ministry of Health

Keywords provided by Gates Malaria Partnership:
malaria
anaemia
school performance
education
intermittent preventive treatment
schools

Additional relevant MeSH terms:
Anemia
Malaria
Malaria, Falciparum
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014