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Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal

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ClinicalTrials.gov Identifier: NCT00712374
Recruitment Status : Unknown
Verified September 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : July 10, 2008
Last Update Posted : September 22, 2009
Sponsor:
Collaborators:
Senegal: Ministere de la Sante
Institut de Recherche pour le Developpement
Cheikh Anta Diop University, Senegal
Information provided by:
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE July 8, 2008
First Posted Date  ICMJE July 10, 2008
Last Update Posted Date September 22, 2009
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
All-causes mortality [ Time Frame: 2008-2010 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
Incidence of malaria by passive case detection [ Time Frame: 2008-2010 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal
Official Title  ICMJE Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal
Brief Summary In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria prevention. Studies in Senegal, Ghana, Mali and The Gambia have shown this approach can be highly effective. In Senegal, seasonal IPT with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). The purpose of the present project is to determine the public health impact and cost effectiveness of this intervention when it is delivered through the routine health service to communities in rural areas in Senegal. Demographic surveillance will be set up in the rural population of three districts (Mbour, Bambey and Fatick) which comprises approximately 540,000 people, including 100,000 children under 5 yrs, and is served by 54 health posts, as an expansion of the area covered by the existing DSS of Niakhar. Information about births, deaths and migrations, household characteristics such as socioeconomic status, and vaccination status of children and their use of bednets, will be recorded in 6-monthly rounds of all households. In selected areas, deaths among children under 10 years will be investigated using verbal autopsies. Over four years from September 2008 - November 2011, seasonal IPT (three monthly administrations of SP (sulfalene-pyrimethamine) plus amodiaquine during the transmission season each year to children 3-59 months of age) will be introduced gradually, in a step-wedge design, by 9 health posts in 2008, by an additional 18 posts in 2009, and another 18 in 2010 and 9 in 2011. At the end of each transmission season, a cross-sectional survey of 2400 children under 5 yrs of age, in which finger prick blood samples will be taken, will be used to estimate the prevalence of molecular markers of drug resistance to Plasmodium falciparum, the prevalence of anaemia and the nutritional status of children. Malaria incidence will be monitored by passive surveillance through health posts, health centres, and hospitals. Cost effectiveness will be assessed. Due to changes in the epidemiology of malaria in the study area, the upper age limit for inclusion was increased from 5 to 10 years old from September 2009.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE Drug: sulfadoxine-pyrimethamine plus amodiaquine

SP+AQ on three occasions during the malaria transmission season

Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine

Study Arms  ICMJE Experimental: Intervention
Children 3 months to 10 years old will receive a treatment dose of SP+AQ on three occasions during the malaria transmission season, delivered by the local health post
Intervention: Drug: sulfadoxine-pyrimethamine plus amodiaquine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 9, 2008)
100000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 3-119 months at time of first administration of IPT in September
  • Consent of mother or carer and the local community

Exclusion Criteria:

  • History of allergy to SP or AQ
  • Age < 3 months or >119 months at time of first administration of IPT in September

From 2009, the age for inclusion has been changed from 3-59 months to 3 months to 10 years of age.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 119 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712374
Other Study ID Numbers  ICMJE PSP01
40099
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Oumar Gaye, Universite Cheikh Anta Diop
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Senegal: Ministere de la Sante
  • Institut de Recherche pour le Developpement
  • Cheikh Anta Diop University, Senegal
Investigators  ICMJE
Study Director: Oumar Gaye, PhD Universite CHeikh Anta Diop
Principal Investigator: Badara Cisse, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Cheikh Sokhna, PhD IRD, Dakar
Principal Investigator: Oumar Faye, MD Ministere de la Sante et de la Prevention
Principal Investigator: Paul Milligan, PhD London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date September 2009

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