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Artemether/Lumefantrine and Vivax Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625871
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : January 17, 2013
University of Kassala, Sudan
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum

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

Condition or disease Intervention/treatment Phase
Vivax Malaria Drug: tablets artemether/lumefantrine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
Study Start Date : September 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

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 Name: Quartem

Primary Outcome Measures :
  1. The cure rate [ Time Frame: 28 days ]
    The proportion of the cure patients

Secondary Outcome Measures :
  1. Fever clearance time [ Time Frame: 28 days ]
    The time for fever clearance

  2. Parasite clearance time [ Time Frame: 28 days ]
    The time for the parasite to clear

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with vivax malaria

Exclusion Criteria:

  • severe malaria
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01625871

Kassala, Sudan, 249
Sponsors and Collaborators
University of Khartoum
University of Kassala, Sudan

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ishag Adam, Professor, University of Khartoum Identifier: NCT01625871     History of Changes
Other Study ID Numbers: vivax
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Ishag Adam, University of Khartoum:

Additional relevant MeSH terms:
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents