Intermittent Antimalaria Treatment With SP in African Children
November 1, 2005 updated by: Charite University, Berlin, Germany
Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
- Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
- It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
- It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
- Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined
Study Type
Interventional
Enrollment
1200
Phase
- Phase 4
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
2 months to 4 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- informed consent by parents or guardian
- no concomitant serious disease
- age >2 months
Exclusion Criteria:
- serious allergy or hypersensitivity to sulfonamides or pyrimethamine
- no severe hepatic or renal dysfunction
- serious breach of study protocol
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: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy and safety of IPTi with SP
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Impact of IPTi on incidence on malaria attacks
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Impact of IPTi on anemia
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Secondary Outcome Measures
Outcome Measure |
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Interaction between erythrocyte polymorphisms and SP
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Influence on parasite multiplicity
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Impact on child development
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Frank Mockenhaupt, PhD, Charite University-Medicine, Berlin, Germany
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.
General Publications
- Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.
- Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
- Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.
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
March 1, 2003
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 2, 2005
Last Update Submitted That Met QC Criteria
November 1, 2005
Last Verified
February 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01KA0202-T
- 01KA0202
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