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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Parasitic Diseases
Protozoan Infections
Artemether
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Coccidiostats
Pharmacologic Actions
Schistosomicides
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014