The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children

Summary

This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.

The study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study children randomly selected will receive three full treatment courses of AS+AQ intermittently during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs) will administer all courses of IPTc. The first dose of each course will be directly observed by the CDDs who will educate mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.

Conditions

• Malaria

Interventions

DRUG

Amodiaquine plus Artesunate co-administration

Under the Home Management of Malaria (HMM) strategy the Community Drug Distributors (CDD) will treat all children under 5 years presented to them with measured fever or a history of fever with AQ plus AS co-administered. Children under 12 months receive 75mg of AQ co-administered with 25mg of AS daily for three days. Children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days. Asymptomatic children under 5 years in the Intermittent Preventive Treatment (IPTc) clusters will receive additional AQ plus AS co-administered during high malaria transmission season. Those under 12 months will receive 75mg of AQ co-administered with 25mg of AS daily for three days; and children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.

Sponsors & Collaborators

• Department for International Development, United Kingdom

  collaborator OTHER_GOV

• Malaria Consortium, UK

  collaborator NETWORK

• Center for International Health and Development

  collaborator OTHER

• Kwame Nkrumah University of Science and Technology

  lead OTHER

Principal Investigators

• Harry Tagbor, DrPH · Department of Community Health, School of Medical Science, Kwame Nkrumah University of Science & Technology

• Edmund Browne, PhD · Department of Community Health, School of Medical Sciences, Kwame Nkrumah University of Science & Technology

• Helen Counihan, PhD · Malaria Consortium, UK

• Sylvia Meek, PhD · Malaria Consortium, UK

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2008-05-31

Completion

2008-10-31

Countries

• Ghana

Study Locations