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Artemether/Lumefantrine and Vivax Malaria

This study has been completed.
Sponsor:
Collaborator:
University of Kassala, Sudan
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum
ClinicalTrials.gov Identifier:
NCT01625871
First received: June 17, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by University of Khartoum:

Primary Outcome Measures:
  • The cure rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The proportion of the cure patients


Secondary Outcome Measures:
  • Fever clearance time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The time for fever clearance

  • Parasite clearance time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with vivax malaria

Exclusion Criteria:

  • severe malaria
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625871

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

Additional Information:
http://www.ncbi.nlm.nih.gov/pubmed?term=adam%20i  This link exits the ClinicalTrials.gov site

Publications:

Additional 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
Study First Received: June 17, 2012
Last Updated: January 16, 2013
Health Authority: Sudan: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013