A Phase 4 interventional study of Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg) in Malaria and Anemia, sponsored by Bernhard Nocht Institute for Tropical Medicine. Completed at 1 site in Ghana. Open to participants aged 2 Months to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-30.
Sponsored by Bernhard Nocht Institute for Tropical Medicine · Phase 4, Interventional, and Prevention
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
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
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 1,070 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Bernhard Nocht Institute for Tropical Medicine is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
• 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
• 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
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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Bernhard Nocht Institute for Tropical Medicine