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

• ClinicalTrials.gov Identifier: NCT00142246
• Recruitment Status: Completed
• First Posted: September 2, 2005
• Last Update Posted: January 26, 2017
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: University of Nairobi
• Information provided by (Responsible Party): Brian Greenwood, London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: August 31, 2005
• First Posted Date: September 2, 2005
• Last Update Posted Date: January 26, 2017
• Study Start Date: January 2005
• Actual Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 7, 2008): Prevalence of anaemia (Hb <112g/L) [ Time Frame: March 2006 ]

Original Primary Outcome Measures (submitted: August 31, 2005)

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

Current Secondary Outcome Measures (submitted: February 7, 2008)

• Prevalence of Plasmodium falciparum parasitaemia [ Time Frame: March 2006 ]
• Sustained attention [ Time Frame: March 2006 ]
• Mean haemoglobin [ Time Frame: March 2006 ]

Original Secondary Outcome Measures (submitted: August 31, 2005)

• Prevalence of Plasmodium falciparum parasitaemia
• Sustained attention

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Malaria, Falciparum

Intervention

• 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.
• 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

Study Arms

• Experimental: 1
  Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)
  Intervention: Drug: Intermittent preventive treatment (SP and amodiaquine)
• Placebo Comparator: 2
  Dual placebo comparator
  Intervention: Other: Placebo

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2008): 6758
• Original Enrollment (submitted: August 31, 2005): 6000
• Actual Study Completion Date: April 2006
• Actual Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kenya

Administrative Information

• NCT Number: NCT00142246
• Other Study ID Numbers: ITDCVG41
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Brian Greenwood, London School of Hygiene and Tropical Medicine
• Original Responsible Party: Not Provided
• Current Study Sponsor: London School of Hygiene and Tropical Medicine
• Original Study Sponsor: Gates Malaria Partnership
• Collaborators: 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

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: January 2017