search
Back to results

Artemether/Lumefantrine and Vivax Malaria

Primary Purpose

Vivax Malaria

Status
Completed
Phase
Phase 3
Locations
Sudan
Study Type
Interventional
Intervention
tablets artemether/lumefantrine
Sponsored by
University of Khartoum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vivax Malaria focused on measuring malaria, vivax, artemether/lumefantrine, Sudan

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 17, 2012
Last Updated
January 16, 2013
Sponsor
University of Khartoum
Collaborators
University of Kassala, Sudan
search

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

We'll reach out to this number within 24 hrs