The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children (KNUST-COMDIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Kwame Nkrumah University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Department for International Development, United Kingdom
Malaria Consortium, UK
Center for International Health and Development
Information provided by:
Kwame Nkrumah University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00550160
First received: October 25, 2007
Last updated: May 25, 2010
Last verified: October 2007
  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 4

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of peripheral parasitaemia [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Prevalence of anaemia [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Parasite density (geometric means) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportions adhering to strategies [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Incidence of adverse drug effects within 7 days after intervention [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1600
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.

Experimental: 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Malaria Consortium, UK
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

No publications provided

Responsible Party: Technical Director, Malaria Consortium, UK
ClinicalTrials.gov Identifier: NCT00550160     History of Changes
Other Study ID Numbers: CKNT_1
Study First Received: October 25, 2007
Last Updated: May 25, 2010
Health Authority: Ghana: Ministry of Health

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 23, 2014