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Intravenous Artesunate and Malaria (IVAS)

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 4
Locations
Sudan
Study Type
Interventional
Intervention
artesunate
Quinine
Sponsored by
University of Khartoum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring severe, Falciaparum, Malaria

Eligibility Criteria

1 Year - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

severe P.falciparum malaria-

Exclusion Criteria:

mixed infection Pregnant women -

Sites / Locations

  • KassalaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

artesunate

quinine

Arm Description

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

quinine infusion 80 mg/kg every 8 hours

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 2, 2013
Last Updated
March 4, 2013
Sponsor
University of Khartoum
Collaborators
University of Kassala, Sudan, Kassala, Sudan
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1. Study Identification

Unique Protocol Identification Number
NCT01805232
Brief Title
Intravenous Artesunate and Malaria
Acronym
IVAS
Official Title
Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
Collaborators
University of Kassala, Sudan, Kassala, Sudan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intravenous artesunate is egual to quinine in the treatment of severe malaria
Detailed Description
Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
severe, Falciaparum, Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
artesunate
Arm Type
Experimental
Arm Description
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
Arm Title
quinine
Arm Type
Active Comparator
Arm Description
quinine infusion 80 mg/kg every 8 hours
Intervention Type
Drug
Intervention Name(s)
artesunate
Intervention Description
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
Intervention Type
Drug
Intervention Name(s)
Quinine
Intervention Description
quinine infusion 80 mg/kg every 8 hours till the patient can take orally
Primary Outcome Measure Information:
Title
clearance of the parasite and fever
Description
To compare the parasite clearance time and fever clearance time between the two groups
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: severe P.falciparum malaria- Exclusion Criteria: mixed infection Pregnant women -
Facility Information:
Facility Name
Kassala
City
Kassala
ZIP/Postal Code
249
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abzinab A Ali, MD
Phone
+249911259199
Ext
122
Email
ishagadamm@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tajeldien A Abdulla, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20850004
Citation
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.
Results Reference
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Intravenous Artesunate and Malaria

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