Artemether/Lumefantrine and Vivax Malaria

January 16, 2013 updated by: Ishag Adam, University of Khartoum

Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan

The cure rate of artemether/lumefantrine in the treatment of vivax malaria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

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
        • Kassala

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

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with vivax malaria

Exclusion Criteria:

  • severe malaria
  • pregnancy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: artemether-lumefantrine
tablets (containing 20mg artemether and 120 mg lumefantrine) for three days
Drug: tablets artemether/lumefantrine
six doses of oral tablets of artemether/lumefantrine
Other Names:
  • Quartem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cure rate
Time Frame: 28 days
The proportion of the cure patients
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fever clearance time
Time Frame: 28 days
The time for fever clearance
28 days
Parasite clearance time
Time Frame: 28 days
The time for the parasite to clear
28 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

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

Helpful Links

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

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 17, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vivax

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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