- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00623155
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali
February 22, 2008 updated by: University of Bamako
Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
262
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bamako, Mali
- Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 1
Control group
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Experimental: 2
Test group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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incidence rate of clinical malaria
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in vivo adequate clinical and parasitological response of P. falciparum to SP
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ogobara Doumbo, MD, University of Bamako
- Principal Investigator: Alassane Dicko, MD, University of Bamako
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
July 1, 2003
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
February 14, 2008
First Submitted That Met QC Criteria
February 22, 2008
First Posted (Estimate)
February 25, 2008
Study Record Updates
Last Update Posted (Estimate)
February 25, 2008
Last Update Submitted That Met QC Criteria
February 22, 2008
Last Verified
September 1, 2002
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Infective Agents, Urinary
- Renal Agents
- Pyrimethamine
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
Other Study ID Numbers
- A10828
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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