Intravenous Artesunate and Malaria (IVAS)

March 4, 2013 updated by: Ishag Adam, University of Khartoum

Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Kassala, Sudan, 249
        • Recruiting
        • Kassala
        • Contact:
        • Principal Investigator:
          • Tajeldien A Abdulla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

severe P.falciparum malaria-

Exclusion Criteria:

mixed infection Pregnant women -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
Drug: artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
Drug: Quinine
quinine infusion 80 mg/kg every 8 hours till the patient can take orally
ACTIVE_COMPARATOR: quinine
quinine infusion 80 mg/kg every 8 hours
Drug: artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
Drug: Quinine
quinine infusion 80 mg/kg every 8 hours till the patient can take orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clearance of the parasite and fever
Time Frame: 3 days
To compare the parasite clearance time and fever clearance time between the two groups
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Khartoum

Collaborators

University of Kassala, Sudan
Kassala
Sudan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2013

Study Completion (ANTICIPATED)

July 1, 2013

Study Registration Dates

First Submitted

March 2, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (ESTIMATE)

March 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • artesunate and malaria

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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