Artemether/Lumefantrine and Vivax Malaria

NCT01625871 — Phase 3, Completed, 38 participants, University of Khartoum
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Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan

RegistryNCT01625871
StatusCompleted
PhasePhase 3
Study typeInterventional; na, single group, masking: none, treatment
Enrollment38 (Actual)
SponsorUniversity of Khartoum (Other); collaborators: University of Kassala, Sudan
ConditionsVivax Malaria
Interventionstablets artemether/lumefantrine (Drug)
Datesstart 2011-09-01, primary completion 2012-09-01, completion 2012-09-01, first posted 2012-06-22, last updated 2013-01-17
Locations1 site in Sudan

Related Papers Related Patents Related Grants Related Experts
All trials for Vivax Malaria All trials of tablets artemether/lumefantrine

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
artemether-lumefantrineExperimentalDrug: tablets artemether/lumefantrinetablets (containing 20mg artemether and 120 mg lumefantrine) for three days
  • tablets artemether/lumefantrine (Drug), also known as Quartem: six doses of oral tablets of artemether/lumefantrine

+Outcome measures

Primary outcomes

  • The cure rate [28 days]: The proportion of the cure patients

Secondary outcomes

  • Fever clearance time [28 days]: The time for fever clearance
  • Parasite clearance time [28 days]: The time for the parasite to clear

+Eligibility

Sex: All, ages: 5 Years to 80 Years

Inclusion Criteria:

* Patients with vivax malaria

Exclusion Criteria:

* severe malaria
* pregnancy

+Locations (1)

FacilityCityCountryStatus
KassalaKassala, KassalaSudan

+Publications

  • Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S5. doi: 10.1186/1475-2875-8-S1-S5. PMID 19818172
  • Results publication: Abdallah TM, Ali AA, Bakri M, Gasim GI, Musa IR, Adam I. Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan. Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404. PMID 23217037