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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Southeast University, China
Information provided by:
University of Khartoum

Study Description
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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
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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

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Uncomplicated malaria

Exclusion Criteria:

  • Severe cases
  • Pregnancy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01075945


Contacts
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Contact: Ishag Adam, MD, PhD +249912168988 ishagadam@hotmail.com
Contact: Fatih M Malik, MD +249911259199 ishagadamm@yahoo.com

Locations
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Sudan
Sinnar Recruiting
Cinnar, Blue Nile, Sudan, 11111
Contact: Ishag Adam, Md, PhD    +249912168988    ishagadam@hotmail.com   
Contact: Fatih M Malik, MD    +249911259199    ishagadamm@yahoo.com   
Principal Investigator: Ishag I Adam, MD, PhD         
Sponsors and Collaborators
University of Khartoum
Southeast University, China
More Information
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Publications:

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Responsible Party: Prof., Univeristy of Khartoum
ClinicalTrials.gov Identifier: NCT01075945    
Other Study ID Numbers: DP v AL01
DP v AL01aasudan ( Other Identifier: Holley )
wadadam
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010
Keywords provided by University of Khartoum:
antimalarials
ACTs
Piperaquine
uncomplicated
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Piperaquine
 Artemether, Lumefantrine Drug Combination
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents