Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Mali
Study Type
Interventional
Intervention
Seasonal IPT in children - Sulfadoxine-pyrimethamine
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring malaria, intermittent preventive treatment, season, children
Eligibility Criteria
Inclusion Criteria:
- Age 6 months to 10 years
- Agree to seek initial medical care for all medical illness in the study clinic during the study period
- Written informed consent by a parent or legal garden,
- No plan to travel for a long time during the study period.
Exclusion Criteria:
- History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
- Chronic illness or symptomatic malaria at the time of enrollment
Sites / Locations
- Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Control group
Test group
Outcomes
Primary Outcome Measures
incidence rate of clinical malaria
in vivo adequate clinical and parasitological response of P. falciparum to SP
Secondary Outcome Measures
Full Information
NCT ID
NCT00623155
First Posted
February 14, 2008
Last Updated
February 22, 2008
Sponsor
University of Bamako
Collaborators
World Health Organization
1. Study Identification
Unique Protocol Identification Number
NCT00623155
Brief Title
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
Official Title
Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2002
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bamako
Collaborators
World Health Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, intermittent preventive treatment, season, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Control group
Arm Title
2
Arm Type
Experimental
Arm Description
Test group
Intervention Type
Drug
Intervention Name(s)
Seasonal IPT in children - Sulfadoxine-pyrimethamine
Intervention Description
Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.
Primary Outcome Measure Information:
Title
incidence rate of clinical malaria
Title
in vivo adequate clinical and parasitological response of P. falciparum to SP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 6 months to 10 years
Agree to seek initial medical care for all medical illness in the study clinic during the study period
Written informed consent by a parent or legal garden,
No plan to travel for a long time during the study period.
Exclusion Criteria:
History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
Chronic illness or symptomatic malaria at the time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ogobara Doumbo, MD
Organizational Affiliation
University of Bamako
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alassane Dicko, MD
Organizational Affiliation
University of Bamako
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako
City
Bamako
Country
Mali
12. IPD Sharing Statement
Citations:
PubMed Identifier
18611271
Citation
Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123.
Results Reference
derived
Learn more about this trial
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
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