Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

Bernhard Nocht Institute for Tropical Medicine

Status and phase

Completed

Phase 4

Conditions

Anemia

Malaria

Treatments

Drug: Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT00206739

01KA0202

01KA0202-K7.3

Details and patient eligibility

About

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

Full 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

Enrollment

1,070 patients

Sex

All

Ages

2 to 4 months old

Volunteers

Accepts Healthy Volunteers

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