Back to resultsArtemether/Lumefantrine and Vivax Malaria
Primary Purpose
Vivax Malaria
Status
Completed
Phase
Phase 3
Locations
Sudan
Study Type
Interventional
Intervention
tablets artemether/lumefantrine
Sponsored by
About this trial
This is an interventional treatment trial for Vivax Malaria focused on measuring malaria, vivax, artemether/lumefantrine, Sudan
Eligibility Criteria
Inclusion Criteria:
- Patients with vivax malaria
Exclusion Criteria:
- severe malaria
- pregnancy
Sites / Locations
- Kassala
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
artemether-lumefantrine
Arm Description
tablets (containing 20mg artemether and 120 mg lumefantrine) for three days
Outcomes
Primary Outcome Measures
The cure rate
The proportion of the cure patients
Secondary Outcome Measures
Fever clearance time
The time for fever clearance
Parasite clearance time
The time for the parasite to clear
Full Information
NCT ID
NCT01625871
First Posted
June 17, 2012
Last Updated
January 16, 2013
Sponsor
University of Khartoum
Collaborators
University of Kassala, Sudan
1. Study Identification
Unique Protocol Identification Number
NCT01625871
Brief Title
Artemether/Lumefantrine and Vivax Malaria
Official Title
Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
Collaborators
University of Kassala, Sudan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The cure rate of artemether/lumefantrine in the treatment of vivax malaria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vivax Malaria
Keywords
malaria, vivax, artemether/lumefantrine, Sudan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
artemether-lumefantrine
Arm Type
Experimental
Arm Description
tablets (containing 20mg artemether and 120 mg lumefantrine) for three days
Intervention Type
Drug
Intervention Name(s)
tablets artemether/lumefantrine
Other Intervention Name(s)
Quartem
Intervention Description
six doses of oral tablets of artemether/lumefantrine
Primary Outcome Measure Information:
Title
The cure rate
Description
The proportion of the cure patients
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Fever clearance time
Description
The time for fever clearance
Time Frame
28 days
Title
Parasite clearance time
Description
The time for the parasite to clear
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with vivax malaria
Exclusion Criteria:
severe malaria
pregnancy
Facility Information:
Facility Name
Kassala
City
Kassala
ZIP/Postal Code
249
Country
Sudan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19818172
Citation
Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S5. doi: 10.1186/1475-2875-8-S1-S5.
Results Reference
background
PubMed Identifier
23217037
Citation
Abdallah TM, Ali AA, Bakri M, Gasim GI, Musa IR, Adam I. Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan. Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed?term=adam%20i
Description
http://www.ncbi.nlm.nih.gov/pubmed?term=adam%20i
Learn more about this trial
Artemether/Lumefantrine and Vivax Malaria
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