Malaria Clinical Trial
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.
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.
Status | Completed |
Enrollment | 2400 |
Est. completion date | July 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 59 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Ghana | Ejisu-Juaben Municipality | Kumasi | Ashanti |
Lead Sponsor | Collaborator |
---|---|
Centre for Global Health Research, Ghana | London School of Hygiene and Tropical Medicine |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptability of seasonal malaria chemoprevention | Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews | 2 months | No |
Primary | Incidence of malaria cases | 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). | 12 months | No |
Secondary | Proportion of children with parasitaemia | Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide.. | 12 months | No |
Secondary | Proportion of children with anaemia | Anaemia is defined as haemoglobin less than <8 g/dL | 12 months | No |
Secondary | Number of referrals | Referrals to hospital and admissions due to malaria and other causes | 12 months | No |
Secondary | Incidence of severe illness | 12 months | No | |
Secondary | Incidence of adverse events | 12 months | Yes |
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