The Synergistic Effects of Home-Management and Intermittent Preventive Treatment of Malaria in Children - Full Text View

Sponsors and Collaborators:	Kwame Nkrumah University of Science and Technology Department for International Development, United Kingdom UK: Malaria Consortium Center for International Health and Development
Information provided by:	Kwame Nkrumah University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00550160

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Amodiaquine plus Artesunate co-administration	Phase IV

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Kwame Nkrumah University of Science and Technology:

Primary Outcome Measures:

Incidence rate of clinical episodes of malaria per child per year [ Time Frame: One year ]

Secondary Outcome Measures:

Prevalence of peripheral parasitaemia [ Time Frame: One year ]
Prevalence of anaemia [ Time Frame: One year ]
Parasite density (geometric means) [ Time Frame: One year ]
Proportions adhering to strategies [ Time Frame: One year ]
Incidence of adverse drug effects within 7 days after intervention [ Time Frame: One year ]

Estimated Enrollment:	1600
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2009

Arms	Assigned Interventions
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 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: 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 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.

Arms

Assigned Interventions

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

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: 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

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.

Eligibility

Ages Eligible for Study:	3 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550160

Contacts

Contact: Harry K Tagbor, DrPH

+233 244 417701

ktagbor@yahoo.com

Locations

Ghana, Ashanti Region
District Health Administration	Recruiting
Ejisu, Ashanti Region, Ghana
Contact: Harry Tagbor, DrPH +233 244 417701 ktagbor@yahoo.com

Sponsors and Collaborators

Kwame Nkrumah University of Science and Technology

Department for International Development, United Kingdom

UK: Malaria Consortium

Center for International Health and Development

Investigators

Principal Investigator:	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

More Information

Study ID Numbers:	CKNT_1
Study First Received:	October 25, 2007
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00550160
Health Authority:	Ghana: Ministry of Health

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Amodiaquine
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Coccidiosis

ClinicalTrials.gov processed this record on January 15, 2009