Intermittent Preventive Treatment in Infant in Mali | NCT00766662

Studies
Intermittent Preventive Treatment in Infant in Mali

NCT00766662

Sponsor

University of Bamako

Status

Completed

Last Update Posted

Oct 6, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Malaria

Interventions

Sulfadoxine pyrimethamine

Countries

Mali

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 3, 2008

First Posted Date

Oct 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2008

Last Update Posted Date

Oct 6, 2008Estimated

Name	Class
UNICEF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

The study was implemented in districts of the region of Koulikoro; the district of Koulikoro and the district of Kolokani. The whole district of Koulikoro was covered by the intervention while in Kolokani, the 22 health areas (sub districts) were randomized in 1:1 ratio with the intervention in 11 health areas and the other 11 serving as control for the assessment of the impact of IPTi implementation on EPI vaccines and other health interventions coverage as well as its impact on the resistance to SP. The implementation consisted of administration of ½ tablet of Sulfadoxine -Pyrimethamine with EPI vaccines (DTP2, DTP3 and Measles vaccine) from December 2006 to December 2007.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Sulfadoxine pyrimethamine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EPI vaccines and other health interventions coverage		1 year
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Resident of Kolokani, Mali
Age less than 24 months

Exclusion Criteria:

Not Resident of Kolokani
Age of 24 months or above

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

23 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako		Bamako		0000	Mali

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22423611	Derived	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.
21767403

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases