Artemether/Lumefantrine and Vivax Malaria

• Sponsor: University of Khartoum (Other)
• Overall Status: Completed
• CT.gov ID: NCT01625871
• Collaborator: University of Kassala, Sudan (Other)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The cure rate of artemether/lumefantrine in the treatment of vivax malaria.

Condition or Disease	Intervention/Treatment	Phase
Vivax Malaria	Drug: tablets artemether/lumefantrine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Quartem

Outcome Measures

Primary Outcome Measures

1. The cure rate [28 days]

   The proportion of the cure patients

Secondary Outcome Measures

1. Fever clearance time [28 days]

   The time for fever clearance

2. Parasite clearance time [28 days]

   The time for the parasite to clear

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with vivax malaria

Exclusion Criteria:

• severe malaria

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kassala	Kassala		Sudan	249

Sponsors and Collaborators

• University of Khartoum
• University of Kassala, Sudan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• http://www.ncbi.nlm.nih.gov/pubmed?term=adam%20i

Publications

• Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1:S5. doi: 10.1186/1475-2875-8-S1-S5. Review.

• Responsible Party: Ishag Adam, Professor, University of Khartoum
• ClinicalTrials.gov Identifier: NCT01625871
• Other Study ID Numbers: vivax
• First Posted: Jun 22, 2012
• Last Update Posted: Jan 17, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Ishag Adam, Professor, University of Khartoum: malaria; vivax; artemether/lumefantrine; Sudan
• Additional relevant MeSH terms: Malaria; Malaria, Vivax; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination

Study Results

No Results Posted as of Jan 17, 2013