B50 B53
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult or paediatric patient with microscopically confirmed malaria and intention for antimalarial treatment Patient or legal guardian able to provide informed consent Patient able and willing to complete follow-up examinations at least until Day 21
Exclusion criteria
Exclusion criteria: Having taken antimalarial drugs for malaria treatment 12 weeks prior to study inclusion (exclusive of prophylaxis) Having taken medication with haemolytic potential 12 weeks prior to inclusion Active Lymphoproliferative diseases (e.g., Lymphoma, Myeloma) Active rheumatic diseases History of autoimmunhaemolytic anaemia Known G6-PD deficiency Sickle cell anaemia or other known haemoglobinopathy Mechanical heart valve replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of clinical or laboratory-diagnosed haemolysis not attributable to malaria in a period of six weeks after the first dose of antimalarial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Any other adverse drug reactions, the degree of haemolysis in relation to risk factors, the duration of haemolysis, immunohaematologic parameters | — |
Countries
Gabon, Germany
Contacts
Medizinische Klinik mit Schwerpunkt Infektiologie und PneumologieCharité - Universitätsmedizin Berlin