Intravenous Artesunate and Malaria

Malaria Clinical Trial

— IVAS  

Official title:

Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01805232
• Other study ID #: artesunate and malaria
• Status: Recruiting
• Phase: Phase 4
• First received: March 2, 2013
• Last updated: March 4, 2013
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: March 2013
• Source: University of Khartoum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sudan: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Intravenous artesunate is egual to quinine in the treatment of severe malaria

Description:

Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 80 Years

Eligibility

Inclusion Criteria:

severe P.falciparum malaria-

Exclusion Criteria:

mixed infection Pregnant women -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• artesunate
intravenous artesunate 80 mg/kg initially then after 8 hours then daily
• Quinine
quinine infusion 80 mg/kg every 8 hours till the patient can take orally

Locations

Country	Name	City	State
Sudan	Kassala	Kassala

Sponsors (4)

Lead Sponsor	Collaborator
University of Khartoum	Kassala, Sudan, University of Kassala, Sudan

Country where clinical trial is conducted

Sudan, 

References & Publications (1)

Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance of the parasite and fever	To compare the parasite clearance time and fever clearance time between the two groups	3 days	No