Anemia, Malaria
Conditions
Keywords
Malaria, Anemia, IPTi, Intermittent Preventive Treatment in Infants, Sulfadoxine-Pyrimethamine, Chemoprophylaxis, Ghana
Brief summary
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
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
Interventions
Sponsors
German Federal Ministry of Education and Research
Deutscher Akademischer Austausch Dienst
The Volkswagen Foundation
Bernhard Nocht Institute for Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 4 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| • Antibody responses against parasite antigens | — |
| • Multiplicity of P. falciparum infections | — |
| • Rate and time points of hospitalizations with anemia, malaria or other diseases | — |
| • Influence of host genetic variants on the rate of P. falciparum infections | — |
| • Proportion of P. falciparum isolates with SP resistance | — |
| • 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 | — |
Countries
Ghana
Outcome results
None listed