Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality

Detailed Description
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In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following parameters are evaluated: i) the level of protection from malaria attacks and episodes of anemia during the treatment period, ii) the level of protection from severe malaria during the treatment period, iii) the effect on malaria morbidity after sustaining treatment, iv) the decrease of overall morbidity and mortality, including the number of hospital admissions and visits of hospital outpatient departments v) the influence of the intervention on the development of drug resistances, vi) the impact of the intervention on the development of immunity, vii) the possible influence of the intervention on sub-clinical organ dysfunction due to chronic Plasmodium falciparum infection. Parts of the study are performed in collaboration with the Laboratory of Research, Hospital Albert Schweitzer, Lambaréné, Gabon and the School of Medicine and Health Sciences, University of Development Studies, Tamale, Ghana

Official Title
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Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infant: a Randomized, Double-blind, and Placebo-controlled Clinical Trial

Conditions
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Malaria, Anemia

Intervention / Treatment
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* Drug: Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent by parent/guardian (written or oral) Permanent residentship in the study area Age of 3 months +/-4 weeks Exclusion Criteria: Hypersensitivity to sulfonamides or pyrimethamine (skin rashes, evidence of hemolysis including dark urine and/or purpura, presumptive signs of bone marrow depression such as sore throat and/or mouth ulcers) Other severe adverse events related to pyrimethamine-sulfadoxine application Signs of severe hepatic or renal dysfunction not due to malaria Other reasons after decision of the study physician

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Efficacy of an extended intermittent treatment with sulfadoxine-pyrimethamine for the control of clinical malaria and anemia (proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 21 months of life) |  |  | 
| • Determination of the rate of clinical malaria and anemia after suspending an extended intermittent treatment for analysis of possible rebound effects |  |  | 
| • Evaluation of safety and adverse effects of the administration of single doses of sulfadoxine-pyrimethamine in infants and children |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Rate and time points of hospitalizations with anemia, malaria or other diseases |  |  | 
| • Rate and time points of severe anemia episodes |  |  | 
| • Proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 12 months of life |  |  | 
| • Antibody responses against parasite antigens |  |  | 
| • Multiplicity of P. falciparum infections |  |  | 
| • Proportion of P. falciparum isolates with SP resistance |  |  | 
| • Influence of host genetic variants on the rate of P. falciparum infections |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Anemia, IPTi, Intermittent Preventive Treatment in Infants, Sulfadoxine-Pyrimethamine, Chemoprophylaxis, Ghana