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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 because the information has not been verified recently.
Verified February 2010 by University of Khartoum.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Southeast University, China
Information provided by:
University of Khartoum
ClinicalTrials.gov Identifier:
NCT01075945
First received: February 18, 2010
Last updated: February 24, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by University of Khartoum:

Primary Outcome Measures:
  • comparing the cure rate between the two drugs [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   5 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncomplicated malaria

Exclusion Criteria:

  • Severe cases
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Prof., Univeristy of Khartoum
ClinicalTrials.gov Identifier: NCT01075945     History of Changes
Other Study ID Numbers: DP v AL01, DP v AL01aasudan, wadadam
Study First Received: February 18, 2010
Last Updated: February 24, 2010
Health Authority: Sudan: Ministry of Health

Keywords provided by University of Khartoum:
antimalarials
ACTs
Piperaquine
uncomplicated

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Dihydroquinghaosu
Piperaquine
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 19, 2013