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Trial of Malaria Seasonal IPTc Combined With Community Case Management

This study has been completed.
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal
ClinicalTrials.gov Identifier:
NCT01449045
First received: September 11, 2011
Last updated: April 25, 2012
Last verified: April 2012
History of Changes

September 11, 2011
April 25, 2012
July 2011
December 2011   (final data collection date for primary outcome measure)
Number of children under 10 years of age with clinical malaria [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
children under 10 years age presenting symptoms of malaria with fever (or history of fever in the previous 48 hours) with a positive Rapid Diagnostic Test or positive blood slides
Same as current
Complete list of historical versions of study NCT01449045 on ClinicalTrials.gov Archive Site
Number of children under 10 years of age presenting clinical Malaria with high parasite density [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Malaria with parasite density at 3000 parasites/uL or more in the presence of fever or history of fever in the previous 48hours in children under 10 years of age
Same as current
Not Provided
Not Provided
 
Trial of Malaria Seasonal IPTc Combined With Community Case Management
Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Malaria
  • Drug: IPTc+CCM
    Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management
  • Drug: Community Case Management with artemether-lumefantrine (AL)
    Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive
  • Placebo Comparator: Community Case Management
    Provision of access to prompt diagnosis and treatment for malaria by community volunteers in the village (PECADOM)
    Intervention: Drug: Community Case Management with artemether-lumefantrine (AL)
  • Experimental: Community Case Management plus IPTc
    Monthly Intermittent Preventive Treatment with sulfadoxine pyrimethamine plus amodiaquine, in addition to community case management
    Intervention: Drug: IPTc+CCM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4554
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age between 3 to 120 months
  • consent participation given by parents or guardians
  • willing to remain in the study area in the next 6 months

Exclusion Criteria:

  • Known allergy to the study investigational drug
  • Any underlying chronic or severe condition.
  • Participant under Treatment with sulfamides
Both
3 Months to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Senegal
 
NCT01449045
SEN11.16, TA.2010.40200.032
Yes
Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal
Cheikh Anta Diop University, Senegal
London School of Hygiene and Tropical Medicine
Study Director: Oumar Gaye, PhD Cheikh Anta Diop University, Senegal
Study Chair: Paul Milligan, PhD London School of Hygiene and Tropical Medicine
Study Chair: Badara Cisse, PhD Cheikh Anta Diop University, Senegal
Cheikh Anta Diop University, Senegal
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP