Clinical trial NCT01651416: Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana
Official title: An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Anaemia
Keywords: Home management of malaria
Seasonal malaria chemoprevention
Lead sponsor: Centre for Global Health Research, Ghana
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2012-07-27
Enrollment: 2400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas.

Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time.

The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.


Eligibility criteria: Inclusion Criteria:

* Children aged between 3-59 months
* Care giver or parent willing to participate and have given informed consent
* Children living in the study area

Exclusion Criteria:

* Children who are unable to take and retain medication
* Children who have a severe or chronic illness
* Children who have a history of serious adverse reaction to the study drugs

Primary outcomes:
measure: Incidence of malaria cases
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of children with parasitaemia
timeFrame: 12 months
measure: Proportion of children with anaemia
timeFrame: 12 months
measure: Number of referrals
timeFrame: 12 months
measure: Incidence of severe illness
timeFrame: 12 months
measure: Incidence of adverse events
timeFrame: 12 months
Other outcomes:
measure: Acceptability of seasonal malaria chemoprevention
timeFrame: 2 months
Locations:
city: Kumasi
country: Ghana
facility: Ejisu-Juaben Municipality
state: Ashanti
Study officials:
affiliation: Kwame Nkrumah University of Science and Technology
name: Harry Tagbor, DrPH
role: PRINCIPAL_INVESTIGATOR
References: