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Artemether/Lumefantrine and Vivax Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625871
First Posted: June 22, 2012
Last Update Posted: October 12, 2017
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.
Collaborator:
University of Kassala, Sudan
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum
  Purpose
The cure rate of artemether/lumefantrine in the treatment of vivax malaria.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ishag Adam, University of Khartoum:

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


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

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


Enrollment: 38
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

Inclusion Criteria:

  • Patients with vivax malaria

Exclusion Criteria:

  • severe malaria
  • pregnancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01625871


Locations
Sudan
Kassala
Kassala, Sudan, 249
Sponsors and Collaborators
University of Khartoum
University of Kassala, Sudan
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01625871     History of Changes
Other Study ID Numbers: vivax
First Submitted: June 17, 2012
First Posted: June 22, 2012
Last Update Posted: October 12, 2017
Last Verified: January 2013

Keywords provided by Ishag Adam, University of Khartoum:
malaria
vivax
artemether/lumefantrine
Sudan

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics