Malaria Paediatrics
Conditions
Interventions
Artesunate
Artesunate (standard treatment)
Sponsors
Prof. Peter Kremsner
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female children from 6 months to 10 years. Clinical diagnosis of severe Plasmodium falciparum malaria requiring hospitalization. Parasitaemia (>5000 parasites per microliter on initial blood smear). Availability of child's parent/guardian and their willingness to provide written informed consent in accordance with the local practice. Willingness and ability to comply with the study protocol for the duration of the study. Willingness to remain in the hospital for 3 days.
Exclusion criteria
Exclusion criteria: Known serious adverse reaction or hypersensitivity to artemisinins, including artemether, dihydroartemisinins or co-artemether (artemether/lumefantrine). Any underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication. Participation in any investigational drug study during 30 days prior to screening. Adequate (according to WHO- and country specific guidelines) antimalarial treatment within 24 hours prior to admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with parasite clearance (>99% reduction from Baseline) at 24hrs after initiation of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic sample collection for subgroup of 300 patients;non-invasive oto-acoustic test;genetic polymorphisms ;in vitro drug sensitivity | — |
Countries
Gabon, Gambia, Ghana, Kenya, Malawi
Contacts
Public ContactStefanie Bolte
Project Manager
Outcome results
None listed