Phase II Artesunate Study in Severe Malaria

This study has been completed.
Sponsor:
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Severe Malaria in African Children Consortium
Information provided by:
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT00522132
First received: August 28, 2007
Last updated: September 15, 2011
Last verified: September 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-Blind Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous Artesunate in Children With Severe Malaria

Resource links provided by NLM:


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
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cohort 1
2.4 mg/kg iv artesunate at 0, 12, 24, 48and 72 hours
Drug: Artesunate
intravenous application
Experimental: cohort 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 and Developing Countries Clinical Trials Partnership (EDCTP)
Severe Malaria in African Children Consortium
Investigators
Principal Investigator: Peter Kremsner, MD University of Tuebingen, Germany
  More Information

No publications provided by Medicines for Malaria Venture

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jörg J. Möhrle, Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT00522132     History of Changes
Other Study ID Numbers: EDCTP/MMV07-01, EDCTP Grant #2004.01.M.d2
Study First Received: August 28, 2007
Last Updated: September 15, 2011
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

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on July 20, 2014