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

NCT00712374 | Unknown Phase 4 DMC

• 2 other identifiers: PSP0140099
• Study Type: interventional
• Target: 100,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria

Keywords

Malaria; All causes mortality; Cost effectiveness

Outcome Measures

Primary Outcomes (1)

• All-causes mortality

  2008-2010

Secondary Outcomes (1)

• Incidence of malaria by passive case detection

  2008-2010

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: sulfadoxine-pyrimethamine plus amodiaquine

Interventions

sulfadoxine-pyrimethamine plus amodiaquine DRUG

SP+AQ on three occasions during the malaria transmission season Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine

Intervention

Eligibility Criteria

• Age: 3 Months - 119 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Senegal: Ministere de la Sante: collaborator
• Institut de Recherche pour le Developpement: collaborator
• Cheikh Anta Diop University, Senegal: collaborator

Related Publications (3)

• 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.

  PMID: 32552759 DERIVED

• 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.

  PMID: 27875528 DERIVED

• 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.

  PMID: 27764102 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination; Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oumar Gaye, PhD

  Universite CHeikh Anta Diop

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 10, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: September 22, 2009

Record last verified: 2009-09