Trial of Malaria Seasonal IPTc Combined With Community Case Management
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Malaria is a major public health problem. 250 million cases annually leads to approximately 1
million deaths. Over 80 per cent of these deaths occur among African children under age five.
The main interventions covered treatment with Artemisinin Combination Therapies (ACT), long
lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria diagnosis.
This has led in Senegal to a substantial decrease in the incidence of malaria, in 2009.
However the recent overall decline hides the fact that malaria incidence remains very high in
the south of Senegal. That's why Home-based management (HMM) for malaria is being introduced
in selected areas. Intermittent Preventive Treatment (IPT) by monthly administration of a
therapeutic dose of antimalarials can achieve a very high degree of protection from attacks
of clinical malaria in children. The purpose of this project is to evaluate the effectiveness
of combining IPTc with HMM in southern Senegal
The study objectives are to :
- Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in
areas with a longer transmission season,
- Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine +
Amodiaquine can offer in populations where a rapid and early care with home management
of malaria is already established.
- Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized
controlled trial has been designed to evaluate the effectiveness of adding seasonal IPTc
with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in
villages where home-based management of malaria is implemented. All villages in Saraya
district, excluding 7 villages with a health post, will be eligible to participate.
Saraya villages will be combined to form 24 clusters which will be randomized to receive
HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community Medicine
Distributors (CMD) will provide HMM. The primary endpoint will be the incidence of
clinical malaria with fever or history of fever and parasitaemia with density of at
least 3000/ul. Secondary outcomes will include the safety, the tolerability, the
coverage and acceptability of the intervention. Both the recurrent and capital costs to
the health service of training staff and delivering the interventions will be estimated.
Both direct and indirect costs to users of the services (children and their families)
will also be assessed.
Phase:
Phase 3
Details
Lead Sponsor:
Cheikh Anta Diop University, Senegal
Collaborator:
London School of Hygiene and Tropical Medicine
Treatments:
Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Fanasil, pyrimethamine drug combination Lumefantrine