Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana
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|ClinicalTrials.gov Identifier: NCT01651416|
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : September 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria Anaemia||Drug: Artemether-lumefantrine combination Drug: Dihydroartemisinin Piperaquine combination Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||July 2013|
Active Comparator: HMM using short-acting ACT
Home management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs
Drug: Artemether-lumefantrine combination
Experimental: HMM using short-acting ACT plus SMC
Home management of malaria using using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs plus seasonal malaria chemoprevention with Amodiaquine plus sulphadoxine-pyrimethamine combination.
Drug: Artemether-lumefantrine combination
Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination
Experimental: HMM using a long-acting ACT
Home management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs
Drug: Dihydroartemisinin Piperaquine combination
Other Name: Duo-cotecxin
- Incidence of malaria cases [ Time Frame: 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).
- Proportion of children with parasitaemia [ Time Frame: 12 months ]Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide..
- Proportion of children with anaemia [ Time Frame: 12 months ]Anaemia is defined as haemoglobin less than <8 g/dL
- Number of referrals [ Time Frame: 12 months ]Referrals to hospital and admissions due to malaria and other causes
- Incidence of severe illness [ Time Frame: 12 months ]
- Incidence of adverse events [ Time Frame: 12 months ]
- Acceptability of seasonal malaria chemoprevention [ Time Frame: 2 months ]Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651416
|Kumasi, Ashanti, Ghana|
|Principal Investigator:||Harry Tagbor, DrPH||Kwame Nkrumah University of Science and Technology|