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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by University of Khartoum.
Recruitment status was:  Recruiting
Southeast University, China
Information provided by:
University of Khartoum Identifier:
First received: February 18, 2010
Last updated: February 24, 2010
Last verified: February 2010
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

Condition Intervention Phase
Malaria Drug: Dihydroartemisinin- piperaquine Drug: artemether- lumefantrine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Khartoum:

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

Estimated Enrollment: 140
Study Start Date: February 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Inclusion Criteria:

  • Uncomplicated malaria

Exclusion Criteria:

  • Severe cases
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01075945

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

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
  More Information

Responsible Party: Prof., Univeristy of Khartoum Identifier: NCT01075945     History of Changes
Other Study ID Numbers: DP v AL01
DP v AL01aasudan ( Other Identifier: Holley )
Study First Received: February 18, 2010
Last Updated: February 24, 2010

Keywords provided by University of Khartoum:

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents
Anthelmintics processed this record on September 21, 2017