Trial of Malaria Seasonal IPTc Combined With Community Case Management
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): IPTc+CCM; Community Case Management with artemether-lumefantrine (AL)
Intervention type(s): Drug; Drug
Intervention description(s): Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management; Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IPTc; Community Case Management; Home Management for malaria