Intermittent Preventive Treatment in Infant in Mali - Full Text View

Sponsors and Collaborators:	University of Bamako UNICEF
Information provided by:	University of Bamako
ClinicalTrials.gov Identifier:	NCT00766662

Purpose

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

Condition	Intervention
Malaria	Drug: Sulfadoxine pyrimethamine

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Fansidar Sulfadoxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment

Further study details as provided by University of Bamako:

Primary Outcome Measures:

EPI vaccines and other health interventions coverage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Study Start Date:	October 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Resident of Kolokani, Mali
Age less than 24 months

Exclusion Criteria:

Not Resident of Kolokani
Age of 24 months or above

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766662

Locations

Mali
Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako
Bamako, Mali, 0000

Sponsors and Collaborators

University of Bamako

UNICEF

Investigators

Principal Investigator:	Alassane Dicko, MD	Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
Study Director:	Ogobara K Doumbo, MD	Faculty of Medicine, Pharmacy and Dentistry; University of Bamako

More Information

No publications provided

Study ID Numbers:	06-55
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766662 History of Changes
Health Authority:	Mali: Ministry of Health

Keywords provided by University of Bamako:

Malaria
Intermittent Preventive Treatment
EPI vaccine coverage
Resistance of P. falciparum to Sulfadoxine- Pyrimethamine

Study placed in the following topic categories:

Folic Acid
Pyrimethamine
Antimalarials
Protozoan Infections
Sulfadoxine-pyrimethamine

Anti-Infective Agents, Urinary
Parasitic Diseases
Malaria
Folic Acid Antagonists
Sulfadoxine

Additional relevant MeSH terms:

Pyrimethamine
Protozoan Infections
Anti-Infective Agents
Sulfadoxine-pyrimethamine
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Anti-Infective Agents, Urinary
Enzyme Inhibitors

Malaria
Renal Agents
Folic Acid Antagonists
Sulfadoxine
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Parasitic Diseases

ClinicalTrials.gov processed this record on May 07, 2009