Overview

Phase II Artesunate Study in Severe Malaria

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the study is to evaluate the effectiveness of 2 intravenous artesunate dosing regimens (2.4 mg/kg initially and at 12, 24, 48, and 72 hours or 4.0 mg/kg initially and at 24 and 48 hours) in clearing P. falciparum parasites in children with severe malaria. Secondary objectives include: - To compare the tolerability and safety of the 2 intravenous artesunate dosing regimens. - To evaluate differences in the pharmacokinetic profile of intravenous artesunate by patient age and clinical presentation.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Severe Malaria in African Children Consortium
Treatments:
Artemisinins
Artesunate
Criteria
Inclusion Criteria:

- Male or female children aged 6 months and ≥ 5kg to 10 years, inclusive.

- Clinical diagnosis of severe P. falciparum malaria (see Appendix B) requiring
hospitalization.

- Parasitemia (more than 5,000 parasites/microL on initial blood smear).

- Availability of child's parent/guardian and their willingness to provide written
informed consent in accordance to local practice.

- Willingness and ability to comply with the study protocol for the duration of the
study.

- Willingness to remain in the hospital for 4 days

Exclusion Criteria:

- Known serious adverse reaction or hypersensitivity to artemisinins, including
artesunate, artemether, dihydroartemisinins or Co-Artem (artemether/lumefantrine).

- Any underlying disease that may compromise the diagnosis and the evaluation of the
response to the study medication (including concomitant infection, concomitant
neurological disease and malnutrition)

- Participation in any investigational drug study during the 30 days prior to Screening.

- Adequate anti-malarial treatment within 24 hours prior to admission.