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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

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 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
U.S. FDA Resources

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01075945


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

Locations
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

Publications:
Responsible Party: Prof., Univeristy of Khartoum
ClinicalTrials.gov Identifier: NCT01075945     History of Changes
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:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemisinins
Piperaquine
Artemether-lumefantrine combination
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics