Phase II Artesunate Study in Severe Malaria - Full Text View

Sponsors and Collaborators:	Medicines for Malaria Venture European Developing Country Clinical Trial Partnership Severe Malaria in African Children Consortium
Information provided by:	Medicines for Malaria Venture
ClinicalTrials.gov Identifier:	NCT00522132

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Artesunate	Phase II

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Randomized, Double-Blind Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous Artesunate in Children With Severe Malaria

Further study details as provided by Medicines for Malaria Venture:

Primary Outcome Measures:

The proportion of patients with parasite clearance (more than 99% reduction from the baseline asexual parasite count) at 24 hours after initiation of study drug. [ Time Frame: 24 hours after initiation of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to total clearance of asexual parasites (PC100) [ Time Frame: after study drug administration ] [ Designated as safety issue: No ]
Time to 99% reduction of asexual parasites (PC99) [ Time Frame: after study drug administration ] [ Designated as safety issue: No ]
Time to 90% reduction of asexual parasites (PC90) [ Time Frame: after study drug administration ] [ Designated as safety issue: No ]
PCR corrected Adequate Clinical and Parasitological Response on day 28 [ Time Frame: on day 28 ] [ Designated as safety issue: No ]
plasma concentrations of artesunate following intravenous administration [ Time Frame: after study drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
cohort 1: Active Comparator 2.4 mg/kg iv artesunate at 0, 12, 24, 48and 72 hours	Drug: Artesunate intravenous application
cohort 2: Experimental 4.0 mg/kg iv Artesunate at 0, 24 and 48 h	Drug: Artesunate intravenous application

Show Detailed Description

Eligibility

Ages Eligible for Study:	6 Months to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522132

Locations

Gabon
Albert Schweitzer Hospital
Lambaréné, Gabon
Universite de Medecine et Science de la Sante
Libreville, Gabon
Malawi
Queen Elizabeth Central Hospital
Blantyre, Malawi

Sponsors and Collaborators

Medicines for Malaria Venture

European Developing Country Clinical Trial Partnership

Severe Malaria in African Children Consortium

Investigators

Principal Investigator:

Peter Kremsner, MD

University of Tuebingen, Germany

More Information

Responsible Party:	Medicines for Malaria Venture ( Jörg J. Möhrle )
Study ID Numbers:	EDCTP/MMV07-01, EDCTP Grant #2004.01.M.d2
Study First Received:	August 28, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00522132
Health Authority:	Gabon: Ministry of Health; Malawi: Ministry of Health,

Keywords provided by Medicines for Malaria Venture:

intravenous artesunate
severe malaria
Plasmodium falciparum
Africa
Severe Plasmodium falciparum Malaria

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009