Severe malarial anaemia Infections and Infestations Malaria, anaemia
Conditions
Interventions
Patients are randomised into one of the following groups:
Group A - lumefantrine-artemether, single 3-day course at enrolment
Group B - lumefantrine-artemether, three 3-day courses (at enrolment, at 1
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Haemoglobin 5 kg at the time of randomization 5. Subject completed blood transfusion(s) in accordance with routine hospital practice 6. Subject completed intravenous (IV) quinine in accordance with routine hospital practice 7. Able to feed (for breastfed children) or eat (for older children) 8. Able to sit unaided 9. Provision of informed consent by parent or guardian
Exclusion criteria
Exclusion criteria: 1. Recognised, specific other cause of severe anaemia at the time of admission to the hospital (e.g. trauma, haematological malignancy, known bleeding disorder, known sickle cell disease) 2. Previous enrolment in the present study 3. Severe anaemia (haemoglobin <5.0 g/dl ) at the time of randomization 4. Known hypersensitivity to any of the study drugs 5. Documented intake of Coartem® (=4 doses) or SP within 1 week prior to admission 6. Child resides outside of catchment area during the course of the study (6 months) 7. Known need at the time of randomization for concomitant prohibited medication during the 2 months randomized treatment period 8. Ongoing participation into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months) 9. Known need, or scheduled surgery during the course of the study (6 months) 10. Suspected non-compliance with the follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 22/04/2010: The incidence of rebound severe anaemia (Hb less than 5 g/L), severe malaria (hospital admissions requiring quinine) or death (a composite endpoint) between 1 and 6 months after enrolment. Initial information at time of registration: Mean haemoglobin at three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 22/04/2010: 1. The incidence of sick-child's clinic visits due to clinical malaria by 3 and 6 months 2. The incidence of all-cause sick-child's clinic visits by 3 and 6 months 3. The incidence of all cause re-hospitalisation between 1 - 3 and 1 - 6 months after enrolment 4. The incidence of the three individual components of the composite endpoint (severe anaemia, severe malaria, death) between 1 - 3 and 1 - 6 months after enrolment 5. Mean haemoglobin at 6 months 6. Incidence of adverse events by 3 and 6 months 7. Mean corrected heart rate (QTc) prolongation by 3 days Initial information at time of registration: 1. The incidence of sick-child's clinic visits due to clinical malaria by 3 and 6 months 2. The incidence of rebound severe anaemia (Hb <5 g/l) 3. The incidence of death by 3 and 6 months 4. Mean haemoglobin at 6 months 5. Incidence of adverse events by 3 and 6 months 6. Mean corrected heart rate (QTc) prolongation by 3 days | — |
Countries
Malawi
Outcome results
None listed