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NCT01625871 Clinical Trial

Artemether/Lumefantrine and Vivax Malaria

Vivax Malaria Clinical Trial

Official title:
Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01625871
Other study ID # vivax
Secondary ID
Status Completed
Phase Phase 3
First received June 17, 2012
Last updated January 16, 2013
Start date September 2011
Est. completion date September 2012

Study information
Verified date January 2013
Source University of Khartoum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The cure rate of artemether/lumefantrine in the treatment of vivax malaria.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 5 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with vivax malaria

Exclusion Criteria:

- severe malaria

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tablets artemether/lumefantrine
six doses of oral tablets of artemether/lumefantrine

Locations
Country Name City State
Sudan Kassala Kassala

Sponsors (2)
Lead Sponsor Collaborator
University of Khartoum University of Kassala, Sudan

Country where clinical trial is conducted

Sudan, 

References & Publications (1)

Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1:S5. doi: 10.1186/1475-2875-8-S1-S5. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The cure rate The proportion of the cure patients 28 days
Secondary Fever clearance time The time for fever clearance 28 days
Secondary Parasite clearance time The time for the parasite to clear 28 days
See also
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Active, not recruiting NCT03529396 - Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients Phase 2
Recruiting NCT05874271 - Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea N/A
Completed NCT05958797 - TES of Chloroquine for Pv in the Philippines in 2016
Completed NCT01716260 - Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan N/A
Completed NCT01288820 - Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria Phase 3
Completed NCT01640574 - Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD) Phase 3
Completed NCT01076868 - Incidence of Vivax Along the Thai Burma Border N/A
Completed NCT00158561 - Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria Phase 3
Completed NCT01780753 - Primaquine Pharmacokinetics in Lactating Women and Their Infants Phase 1
Completed NCT06044805 - Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Phase 4

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