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

NCT00550160 | Completed Phase 4

• 1 other identifier: CKNT_1
• Study Type: interventional
• Target: 1,490
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence rate of clinical episodes of malaria per child per year

  One year

Secondary Outcomes (5)

• Prevalence of peripheral parasitaemia

  One year

• Prevalence of anaemia

  One year

• Parasite density (geometric means)

  One year

• Proportions adhering to strategies

  One year

• Incidence of adverse drug effects within 7 days after intervention

  One year

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Drug: Amodiaquine plus Artesunate co-administration

2

EXPERIMENTAL

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

Drug: Amodiaquine plus Artesunate co-administration

Interventions

Amodiaquine plus Artesunate co-administration 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.

1; 2

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kwame Nkrumah University of Science and Technology: lead
• Department for International Development, United Kingdom: collaborator
• Malaria Consortium, UK: collaborator
• Center for International Health and Development: collaborator

Study Sites (1)

District Health Administration

Ejisu, Ashanti Region, Ghana

Location

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Harry Tagbor, DrPH

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

  PRINCIPAL INVESTIGATOR

• Edmund Browne, PhD

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

  PRINCIPAL INVESTIGATOR

• Helen Counihan, PhD

  Malaria Consortium, UK

  PRINCIPAL INVESTIGATOR

• Sylvia Meek, PhD

  Malaria Consortium, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 29, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

GH (1)