Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan

• Sponsor: University of Khartoum (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01075945
• Collaborator: Southeast University, China (Other)
• Enrollment: 140
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 72.2

Study Details

Study Description

Brief Summary

Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Dihydroartemisinin- piperaquine; Drug: artemether- lumefantrine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2010
• Anticipated Primary Completion Date: Apr 1, 2010
• Anticipated Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dihydroartemisinin- piperaquine orally tablets	Drug: Dihydroartemisinin- piperaquine; three tablets per day; Other Names: Hoy-Cotec ; Drug: artemether- lumefantrine; twenty tablet in eight doses; Other Names: Coartem
Active Comparator: artemether- lumefantrine oral tablets	Drug: artemether- lumefantrine; twenty tablet in eight doses; Other Names: Coartem

Outcome Measures

Primary Outcome Measures

1. comparing the cure rate between the two drugs [3 months]

   PCR cure rate Parasite clearance time Fever clearance time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Uncomplicated malaria

Exclusion Criteria:

• Severe cases

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinnar	Cinnar	Blue Nile	Sudan	11111

Sponsors and Collaborators

• University of Khartoum
• Southeast University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Adam I, Elmardi KA, Malik EM. Predictors of antimalarial treatment failure in an area of unstable malaria transmission in eastern Sudan. Trans R Soc Trop Med Hyg. 2009 Jan;103(1):21-4. doi: 10.1016/j.trstmh.2008.07.005. Epub 2008 Aug 20.

• ClinicalTrials.gov Identifier: NCT01075945
• Other Study ID Numbers: DP v AL01; DP v AL01aasudan; wadadam
• First Posted: Feb 25, 2010
• Last Update Posted: Feb 25, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: antimalarials; ACTs; Piperaquine; uncomplicated
• Additional relevant MeSH terms: Malaria; Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Artenimol

Study Results

No Results Posted as of Feb 25, 2010