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

Malaria Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01075945
• Other study ID #: DP v AL01
• Secondary ID: DP v AL01aasudan
• Status: Unknown status
• Phase: Phase 4
• First received: February 18, 2010
• Last updated: February 24, 2010
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: February 2010
• Source: University of Khartoum
• Contact: Ishag Adam, MD, PhD
• Phone: +249912168988
• Email: ishagadam[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 95 Years

Eligibility

Inclusion Criteria:

• Uncomplicated malaria

Exclusion Criteria:

• Severe cases

• Pregnancy

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Dihydroartemisinin- piperaquine
three tablets per day
• artemether- lumefantrine
twenty tablet in eight doses

Locations

Country	Name	City	State
Sudan	Sinnar	Cinnar	Blue Nile

Sponsors (2)

Lead Sponsor	Collaborator
University of Khartoum	Southeast University, China

Country where clinical trial is conducted

Sudan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparing the cure rate between the two drugs	PCR cure rate Parasite clearance time Fever clearance time	3 months