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

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sulfadoxine-pyrimethamine plus amodiaquine
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria, All causes mortality, Cost effectiveness

Eligibility Criteria

3 Months - 119 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    All-causes mortality

    Secondary Outcome Measures

    Incidence of malaria by passive case detection

    Full Information

    First Posted
    July 8, 2008
    Last Updated
    September 21, 2009
    Sponsor
    London School of Hygiene and Tropical Medicine
    Collaborators
    Senegal: Ministere de la Sante, Institut de Recherche pour le Developpement, Cheikh Anta Diop University, Senegal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00712374
    Brief Title
    Evaluation of the Public Health Impact of Seasonal Intermittent Preventive Treatment (IPT) in Children in Senegal
    Official Title
    Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    December 2011 (Anticipated)
    Study Completion Date
    July 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    London School of Hygiene and Tropical Medicine
    Collaborators
    Senegal: Ministere de la Sante, Institut de Recherche pour le Developpement, Cheikh Anta Diop University, Senegal

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria
    Keywords
    Malaria, All causes mortality, Cost effectiveness

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    sulfadoxine-pyrimethamine plus amodiaquine
    Intervention Description
    SP+AQ on three occasions during the malaria transmission season Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine
    Primary Outcome Measure Information:
    Title
    All-causes mortality
    Time Frame
    2008-2010
    Secondary Outcome Measure Information:
    Title
    Incidence of malaria by passive case detection
    Time Frame
    2008-2010

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    119 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oumar Gaye, PhD
    Organizational Affiliation
    Universite CHeikh Anta Diop
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Badara Cisse, PhD
    Organizational Affiliation
    London School of Hygiene and Tropical Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Cheikh Sokhna, PhD
    Organizational Affiliation
    IRD, Dakar
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Oumar Faye, MD
    Organizational Affiliation
    Ministere de la Sante et de la Prevention
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paul Milligan, PhD
    Organizational Affiliation
    London School of Hygiene and Tropical Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32552759
    Citation
    Dieng S, Ba EH, Cisse B, Sallah K, Guindo A, Ouedraogo B, Piarroux M, Rebaudet S, Piarroux R, Landier J, Sokhna C, Gaudart J. Spatio-temporal variation of malaria hotspots in Central Senegal, 2008-2012. BMC Infect Dis. 2020 Jun 17;20(1):424. doi: 10.1186/s12879-020-05145-w.
    Results Reference
    derived
    PubMed Identifier
    27875528
    Citation
    Cisse B, Ba EH, Sokhna C, NDiaye JL, Gomis JF, Dial Y, Pitt C, NDiaye M, Cairns M, Faye E, NDiaye M, Lo A, Tine R, Faye S, Faye B, Sy O, Konate L, Kouevijdin E, Flach C, Faye O, Trape JF, Sutherland C, Fall FB, Thior PM, Faye OK, Greenwood B, Gaye O, Milligan P. Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial. PLoS Med. 2016 Nov 22;13(11):e1002175. doi: 10.1371/journal.pmed.1002175. eCollection 2016 Nov.
    Results Reference
    derived
    PubMed Identifier
    27764102
    Citation
    NDiaye JL, Cisse B, Ba EH, Gomis JF, Ndour CT, Molez JF, Fall FB, Sokhna C, Faye B, Kouevijdin E, Niane FK, Cairns M, Trape JF, Rogier C, Gaye O, Greenwood BM, Milligan PJ. Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial. PLoS One. 2016 Oct 20;11(10):e0162563. doi: 10.1371/journal.pone.0162563. eCollection 2016. Erratum In: PLoS One. 2016 Dec 8;11(12 ):e0168421.
    Results Reference
    derived

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

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