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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01075945
Recruitment Status : Unknown
Verified February 2010 by University of Khartoum.
Recruitment status was:  Recruiting
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Southeast University, China
Information provided by:
University of Khartoum

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2010
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Dihydroartemisinin- piperaquine
orally tablets
Drug: Dihydroartemisinin- piperaquine
three tablets per day
Other Name: Hoy-Cotec

Drug: artemether- lumefantrine
twenty tablet in eight doses
Other Name: Coartem

Active Comparator: artemether- lumefantrine
oral tablets
Drug: artemether- lumefantrine
twenty tablet in eight doses
Other Name: Coartem

Primary Outcome Measures :
  1. comparing the cure rate between the two drugs [ Time Frame: 3 months ]
    PCR cure rate Parasite clearance time Fever clearance time

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Uncomplicated malaria

Exclusion Criteria:

  • Severe cases
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01075945

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Contact: Ishag Adam, MD, PhD +249912168988
Contact: Fatih M Malik, MD +249911259199

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Sinnar Recruiting
Cinnar, Blue Nile, Sudan, 11111
Contact: Ishag Adam, Md, PhD    +249912168988   
Contact: Fatih M Malik, MD    +249911259199   
Principal Investigator: Ishag I Adam, MD, PhD         
Sponsors and Collaborators
University of Khartoum
Southeast University, China
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Responsible Party: Prof., Univeristy of Khartoum Identifier: NCT01075945    
Other Study ID Numbers: DP v AL01
DP v AL01aasudan ( Other Identifier: Holley )
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010
Keywords provided by University of Khartoum:
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Artemether, Lumefantrine Drug Combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents