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

Kwame Nkrumah University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: Amodiaquine plus Artesunate co-administration

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00550160

CKNT_1

Details and patient eligibility

About

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.

Enrollment: 1,490 patients

Sex: All

Ages: 3 to 59 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,490 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Drug: Amodiaquine plus Artesunate co-administration

2

Experimental group

Description:

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

Treatment:

Drug: Amodiaquine plus Artesunate co-administration