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Phase II Artesunate Study in Severe Malaria

NCT00522132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-09-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Artesunate

intravenous application

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Severe Malaria in African Children Consortium

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Peter Kremsner, MD · Universität Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-06-30
Completion
2008-12-31

Countries

  • Gabon
  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522132 on ClinicalTrials.gov