Malaria, Anaemia
Conditions
Keywords
Home management of malaria, Seasonal malaria chemoprevention
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.
Interventions
DRUGDihydroartemisinin Piperaquine combination
DRUGAmodiaquine plus sulphadoxine-pyrimethamine combination
Sponsors
London School of Hygiene and Tropical Medicine
Centre for Global Health Research, Ghana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of malaria cases | 12 months | Incidence of malaria cases recorded by the community health workers (CHWs) and at the study health centres. Malaria will be defined as fever or history of fever combined with parasitologically confirmed P. falciparum infection by blood slide. Management of suspected malaria cases reporting to CHWs and health centres will be according to rapid diagnostic test (RDT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children with parasitaemia | 12 months | Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide.. |
| Proportion of children with anaemia | 12 months | Anaemia is defined as haemoglobin less than \<8 g/dL |
| Incidence of severe illness | 12 months | — |
| Incidence of adverse events | 12 months | — |
| Number of referrals | 12 months | Referrals to hospital and admissions due to malaria and other causes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of seasonal malaria chemoprevention | 2 months | Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews |
Countries
Ghana
Outcome results
None listed