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

This study is enrolling participants by invitation only.
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
ClinicalTrials.gov Identifier:
NCT00712374
First received: July 8, 2008
Last updated: September 21, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: sulfadoxine-pyrimethamine plus amodiaquine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • All-causes mortality [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of malaria by passive case detection [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100000
Study Start Date: September 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: sulfadoxine-pyrimethamine plus amodiaquine

SP+AQ on three occasions during the malaria transmission season

Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine


  Eligibility

Ages Eligible for Study:   3 Months to 119 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712374

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Senegal: Ministere de la Sante
Institut de Recherche pour le Developpement
Cheikh Anta Diop University, Senegal
Investigators
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
  More Information

No publications provided

Responsible Party: Prof Oumar Gaye, Universite Cheikh Anta Diop
ClinicalTrials.gov Identifier: NCT00712374     History of Changes
Other Study ID Numbers: PSP01, 40099
Study First Received: July 8, 2008
Last Updated: September 21, 2009
Health Authority: Senegal: Ministere de la sante

Keywords provided by London School of Hygiene and Tropical Medicine:
Malaria
All causes mortality
Cost effectiveness

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on August 27, 2014