- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01625871
Artemether/Lumefantrine and Vivax Malaria
January 16, 2013 updated by: Ishag Adam, University of Khartoum
Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
The cure rate of artemether/lumefantrine in the treatment of vivax malaria.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kassala, Sudan, 249
- Kassala
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with vivax malaria
Exclusion Criteria:
- severe malaria
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: artemether-lumefantrine
tablets (containing 20mg artemether and 120 mg lumefantrine) for three days
|
six doses of oral tablets of artemether/lumefantrine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The cure rate
Time Frame: 28 days
|
The proportion of the cure patients
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fever clearance time
Time Frame: 28 days
|
The time for fever clearance
|
28 days
|
Parasite clearance time
Time Frame: 28 days
|
The time for the parasite to clear
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
June 17, 2012
First Submitted That Met QC Criteria
June 19, 2012
First Posted (Estimate)
June 22, 2012
Study Record Updates
Last Update Posted (Estimate)
January 17, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- vivax
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vivax Malaria
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University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts, Amherst and other collaboratorsRecruitingPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLao People's Democratic Republic
-
Medicines for Malaria VentureAsociacion Civil Selva AmazonicaCompletedPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
-
University of OxfordMenzies School of Health ResearchCompletedUncomplicated Vivax MalariaAfghanistan, Ethiopia, Indonesia, Vietnam
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Centers for Disease Control and PreventionTerminated
-
Menzies School of Health ResearchMinistry of Health, MalaysiaUnknownPlasmodium Vivax Malaria Without ComplicationMalaysia
-
Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis Ababa... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaEthiopia, Bangladesh, Indonesia
-
Menzies School of Health ResearchAga Khan University; University of Melbourne; Universitas Sumatera Utara; Ethiopian... and other collaboratorsRecruitingVivax Malaria | Malaria, Vivax | Plasmodium Vivax | Malaria RelapseCambodia, Ethiopia, Indonesia, Pakistan
-
Menzies School of Health ResearchUniversity of Melbourne; Curtin University; Addis Ababa University; Fundação de... and other collaboratorsNot yet recruitingVivax MalariaBrazil, Ethiopia, Indonesia, Papua New Guinea
-
University of OxfordCompleted
-
London School of Hygiene and Tropical MedicineHealthNet TPOCompletedMalaria | Vivax MalariaPakistan
Clinical Trials on tablets artemether/lumefantrine
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Dafra PharmaKenya Medical Research InstituteCompleted
-
University of OxfordMahidol University; Mahidol Oxford Tropical Medicine Research UnitTerminatedHealthy | Pharmacokinetic | Drug CombinationThailand
-
University of Cape TownLondon School of Hygiene and Tropical MedicineCompletedHIV | MalariaSouth Africa
-
University of OxfordUniversity of KinshasaCompleted
-
London School of Hygiene and Tropical MedicineRadboud University Medical Center; Centre national de recherche et de formation...Completed
-
Novartis PharmaceuticalsMedicines for Malaria VentureCompletedAcute Uncomplicated Falciparum MalariaBurkina Faso, Benin, Congo, Nigeria, Togo
-
University of LiverpoolInfectious Diseases Institute, Makerere University College of Health Sciences and other collaboratorsRecruitingMalaria,FalciparumUganda
-
Novartis PharmaceuticalsCenters for Disease Control and PreventionCompletedMalariaUnited States
-
NovartisCompletedMalaria | FalciparumBenin, Kenya, Mali, Mozambique, Tanzania
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Centers for Disease Control and PreventionIfakara Health Research and Development CentreCompleted