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
About this trial
This is an interventional prevention trial for Malaria focused on measuring Malaria, All causes mortality, Cost effectiveness
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.
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
NCT ID
NCT00712374
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
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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