NCT01805232

Brief Summary

Intravenous artesunate is egual to quinine in the treatment of severe malaria

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

March 2, 2013

Last Update Submit

March 4, 2013

Conditions

Malaria

Keywords

severeFalciaparumMalaria

Outcome Measures

Primary Outcomes (1)

  • clearance of the parasite and fever

    To compare the parasite clearance time and fever clearance time between the two groups

    3 days

Study Arms (2)

artesunate

EXPERIMENTAL

intravenous artesunate 80 mg/kg initially then after 8 hours then daily

Drug: artesunateDrug: Quinine

quinine

ACTIVE COMPARATOR

quinine infusion 80 mg/kg every 8 hours

Drug: artesunateDrug: Quinine

Interventions

artesunateDRUG

intravenous artesunate 80 mg/kg initially then after 8 hours then daily

artesunatequinine
QuinineDRUG

quinine infusion 80 mg/kg every 8 hours till the patient can take orally

artesunatequinine

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • severe P.falciparum malaria-

You may not qualify if:

  • mixed infection Pregnant women -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kassala

Kassala, Kassala, 249, Sudan

RECRUITING

Related Publications (1)

  • Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17.

    PMID: 20850004BACKGROUND

MeSH Terms

Conditions

MalariaLymphoma, Follicular

Interventions

ArtesunateQuinine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsCinchona AlkaloidsAlkaloidsHeterocyclic CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2013

First Posted

March 6, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

SU(1)