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

NCT ID: NCT00550160

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1

The Home Management of Malaria (HMM) is a strategy aimed at improving access to prompt and effective antimalarial treatment of all fevers in children under 5 years. Community Drug Distributors (CDD) have been trained and equipped for this task.

Group Type: ACTIVE_COMPARATOR

Amodiaquine plus Artesunate co-administration

Intervention Type: DRUG

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.

2

An Intermittent Preventive Treatment (IPTc) schedule for asymptomatic pre-school children during high malaria transmission seasons alongside an ongoing Home Management of Malaria programme

Group Type: EXPERIMENTAL

Amodiaquine plus Artesunate co-administration

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A child in the study cohort will be eligible to receive a course of IPTc (active or placebo) if the child has NO fever (a temperature of 37•5o C or above) or history of fever in the last 24 hours. However, fever is only a temporary exclusion criterion. If a child has fever when he/she is due for an IPTc course, treatment will be given for the fever and the IPTc course given one month after the fever has subsided. This interval between treatment of fever episodes and administration of an IPTc course is proposed in order to minimise the risk of overdosing since the same drug is used for both HMM and IPTc.

Exclusion Criteria

• A child in the study cohort will not be eligible to receive a course of IPTc if:

• The child has a clinical condition that may be classified as severe according to IMCI guidelines.
• The child is known to suffer from chronic disease(s) e.g. sickle cell disease that might adversely affect the interpretation of study results.
• The mother/caregiver withdraws consent.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Malaria Consortium, UK

NETWORK

Sponsor Role: collaborator

Center for International Health and Development

OTHER

Sponsor Role: collaborator

Kwame Nkrumah University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Dr. Harry Tagbor

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harry Tagbor, DrPH

Role: PRINCIPAL_INVESTIGATOR

Department of Community Health, School of Medical Science, Kwame Nkrumah University of Science & Technology

Edmund Browne, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Community Health, School of Medical Sciences, Kwame Nkrumah University of Science & Technology

Helen Counihan, PhD

Role: PRINCIPAL_INVESTIGATOR

Malaria Consortium, UK

Sylvia Meek, PhD

Role: PRINCIPAL_INVESTIGATOR

Malaria Consortium, UK

Locations

District Health Administration

Ejisu, Ashanti Region, Ghana

Countries

Ghana

Other Identifiers

CKNT_1

Identifier Type: -

Identifier Source: org_study_id