NCT00766662

Brief Summary

Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

  • to develop an implementation model for IPTi in the health care system in Mali
  • to assess its impact on the EPI vaccines and other health interventions coverage
  • and on molecular makers of resistance to SP

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
Last Updated

October 6, 2008

Status Verified

September 1, 2008

Enrollment Period

1.2 years

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Keywords

MalariaIntermittent Preventive TreatmentEPI vaccine coverageResistance of P. falciparum to Sulfadoxine- Pyrimethamine

Outcome Measures

Primary Outcomes (2)

  • EPI vaccines and other health interventions coverage

    1 year

  • Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine

    1 year

Interventions

Eligibility Criteria

AgeUp to 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Resident of Kolokani, Mali
  • Age less than 24 months

You may not qualify if:

  • Not Resident of Kolokani
  • Age of 24 months or above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako

Bamako, 0000, Mali

Location

Related Publications (2)

  • Dicko A, Konare M, Traore D, Testa J, Salamon R, Doumbo O, Rogier C. The implementation of malaria intermittent preventive trialtreatment with sulphadoxine-pyrimethamine in infants reduced all-cause mortality in the district of Kolokani, Mali: results from a cluster randomized control. Malar J. 2012 Mar 16;11:73. doi: 10.1186/1475-2875-11-73.

  • Dicko A, Toure SO, Traore M, Sagara I, Toure OB, Sissoko MS, Diallo AT, Rogier C, Salomon R, de Sousa A, Doumbo OK. Increase in EPI vaccines coverage after implementation of intermittent preventive treatment of malaria in infant with Sulfadoxine -pyrimethamine in the district of Kolokani, Mali: results from a cluster randomized control trial. BMC Public Health. 2011 Jul 18;11:573. doi: 10.1186/1471-2458-11-573.

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Alassane Dicko, MD

    Faculty of Medicine, Pharmacy and Dentistry; University of Bamako

    PRINCIPAL INVESTIGATOR
  • Ogobara K Doumbo, MD

    Faculty of Medicine, Pharmacy and Dentistry; University of Bamako

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

October 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 6, 2008

Record last verified: 2008-09

Locations