NCT00522132

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 16, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

August 28, 2007

Last Update Submit

September 15, 2011

Conditions

Malaria

Keywords

intravenous artesunatesevere malariaPlasmodium falciparumAfricaSevere Plasmodium falciparum Malaria

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours after initiation of study

Secondary Outcomes (5)

  • Time to total clearance of asexual parasites (PC100)

    after study drug administration

  • Time to 99% reduction of asexual parasites (PC99)

    after study drug administration

  • Time to 90% reduction of asexual parasites (PC90)

    after study drug administration

  • PCR corrected Adequate Clinical and Parasitological Response on day 28

    on day 28

  • plasma concentrations of artesunate following intravenous administration

    after study drug administration

Study Arms (2)

cohort 1

ACTIVE COMPARATOR

2.4 mg/kg iv artesunate at 0, 12, 24, 48and 72 hours

Drug: Artesunate

cohort 2

EXPERIMENTAL

4.0 mg/kg iv Artesunate at 0, 24 and 48 h

Drug: Artesunate

Interventions

ArtesunateDRUG

intravenous application

cohort 1cohort 2

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Albert Schweitzer Hospital

Lambaréné, Gabon

Location

Universite de Medecine et Science de la Sante

Libreville, Gabon

Location

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Related Publications (1)

  • Kremsner PG, Taylor T, Issifou S, Kombila M, Chimalizeni Y, Kawaza K, Bouyou Akotet MK, Duscha M, Mordmuller B, Kosters K, Humberg A, Miller RS, Weina P, Duparc S, Mohrle J, Kun JF, Planche T, Teja-Isavadharm P, Simpson JA, Kohler C, Krishna S. A simplified intravenous artesunate regimen for severe malaria. J Infect Dis. 2012 Jan 15;205(2):312-9. doi: 10.1093/infdis/jir724. Epub 2011 Dec 15.

    PMID: 22180622DERIVED

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Peter Kremsner, MD

    Universität Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 29, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

September 16, 2011

Record last verified: 2011-09

Locations

MA(1)GA(2)