Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan
3 other identifiers
interventional
140
1 country
1
Brief Summary
Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 25, 2010
February 1, 2010
2 months
February 18, 2010
February 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
comparing the cure rate between the two drugs
PCR cure rate Parasite clearance time Fever clearance time
3 months
Study Arms (2)
Dihydroartemisinin- piperaquine
EXPERIMENTALorally tablets
artemether- lumefantrine
ACTIVE COMPARATORoral tablets
Interventions
three tablets per day
twenty tablet in eight doses
Eligibility Criteria
You may qualify if:
- Uncomplicated malaria
You may not qualify if:
- Severe cases
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Khartoumlead
- Southeast University, Chinacollaborator
Study Sites (1)
Sinnar
Cinnar, Blue Nile, 11111, Sudan
Related Publications (1)
Adam I, Elmardi KA, Malik EM. Predictors of antimalarial treatment failure in an area of unstable malaria transmission in eastern Sudan. Trans R Soc Trop Med Hyg. 2009 Jan;103(1):21-4. doi: 10.1016/j.trstmh.2008.07.005. Epub 2008 Aug 20.
PMID: 18718621BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 25, 2010
Study Start
February 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 25, 2010
Record last verified: 2010-02