NCT01625871

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

June 17, 2012

Last Update Submit

January 16, 2013

Conditions

Vivax Malaria

Keywords

malariavivaxartemether/lumefantrineSudan

Outcome Measures

Primary Outcomes (1)

  • The cure rate

    The proportion of the cure patients

    28 days

Secondary Outcomes (2)

  • Fever clearance time

    28 days

  • Parasite clearance time

    28 days

Study Arms (1)

artemether-lumefantrine

EXPERIMENTAL

tablets (containing 20mg artemether and 120 mg lumefantrine) for three days

Drug: tablets artemether/lumefantrine

Interventions

tablets artemether/lumefantrineDRUG

six doses of oral tablets of artemether/lumefantrine

Also known as: Quartem
artemether-lumefantrine

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with vivax malaria

You may not qualify if:

  • severe malaria
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kassala

Kassala, Kassala, 249, Sudan

Location

Related Publications (2)

  • 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: 19818172BACKGROUND

  • 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: 23217037DERIVED

Related Links

MeSH Terms

Conditions

Malaria, VivaxMalaria

Interventions

ArtemetherLumefantrine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 22, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

SU(1)