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

Malaria Clinical Trial

— KNUST-COMDIS  

Official title:

The Clinical Impact of Seasonal Intermittent Preventive Treatment (IPT) and Home Management of Malaria (HMM) Using AQ+AS in Ghanaian Children Under 5 Years of Age - a Cluster Randomised Placebo Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550160
• Other study ID #: CKNT_1
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2007
• Last updated: September 17, 2015
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: September 2015
• Source: Kwame Nkrumah University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1490
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
Ghana	District Health Administration	Ejisu	Ashanti Region

Sponsors (4)

Lead Sponsor	Collaborator
Kwame Nkrumah University of Science and Technology	Center for International Health and Development, Department for International Development, United Kingdom, Malaria Consortium, UK

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of clinical episodes of malaria per child per year		One year	No
Secondary	Prevalence of peripheral parasitaemia		One year	No
Secondary	Prevalence of anaemia		One year	No
Secondary	Parasite density (geometric means)		One year	No
Secondary	Proportions adhering to strategies		One year	No
Secondary	Incidence of adverse drug effects within 7 days after intervention		One year	Yes