Clinical trial NCT00550160: The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Kwame Nkrumah University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Department for International Development, United Kingdom
name: Malaria Consortium, UK
name: Center for International Health and Development
First posted: 2007-10-29
Enrollment: 1490
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Incidence rate of clinical episodes of malaria per child per year
timeFrame: One year
Secondary outcomes:
measure: Prevalence of peripheral parasitaemia
timeFrame: One year
measure: Prevalence of anaemia
timeFrame: One year
measure: Parasite density (geometric means)
timeFrame: One year
measure: Proportions adhering to strategies
timeFrame: One year
measure: Incidence of adverse drug effects within 7 days after intervention
timeFrame: One year
Other outcomes:
Locations:
city: Ejisu
country: Ghana
facility: District Health Administration
state: Ashanti Region
Study officials:
affiliation: Department of Community Health, School of Medical Science, Kwame Nkrumah University of Science & Technology
name: Harry Tagbor, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Community Health, School of Medical Sciences, Kwame Nkrumah University of Science & Technology
name: Edmund Browne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaria Consortium, UK
name: Helen Counihan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaria Consortium, UK
name: Sylvia Meek, PhD
role: PRINCIPAL_INVESTIGATOR
References: