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Trial registered on ANZCTR


Registration number
ACTRN12605000551695
Ethics application status
Approved
Date submitted
27/09/2005
Date registered
29/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of artemisinin combination treatment in the form of Coartem® (artemether-lumefantrine) with sulfadoxine-pyrimethamine for treatment of uncomplicated malaria in Jhapa District, Nepal
Scientific title
A comparison of artemisinin combination treatment in the form of Coartem® (artemether-lumefantrine) with sulfadoxine-pyrimethamine for treatment of uncomplicated malaria in Jhapa District, Nepal
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 676 0
Condition category
Condition code
Infection 750 750 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Artemether-lumefantrine or sulfadoxine pyrmethamine both given in recommended dose regimens (6 doses over 3 days for artemether-lumefantrine and a single dose for sulfadoxine pyrimethamine).
Intervention code [1] 685 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 937 0
28-day parasitological cure rate defined by conventional World Health Organisation (WHO) criteria
Timepoint [1] 937 0
Secondary outcome [1] 1790 0
Side effects
Timepoint [1] 1790 0
Secondary outcome [2] 1791 0
Parasite clearance time
Timepoint [2] 1791 0
Secondary outcome [3] 1792 0
Fever clearance time.
Timepoint [3] 1792 0

Eligibility
Key inclusion criteria
i) Uncomplicated falciparum or mixed falciparum/vivax infection, ii) Asexual parasite density >500/ul whole blood, iii) No prior antimalarial therapy within the last 3 months, iv) Temperature > 37.5C axillary, v) Absence of sensitivity to SP or chloroquine, vi) Ability to attend follow-up visits.
Minimum age
5 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be 2 artemether-lumefantrine cases to every 1 sulfadoxine-pyrimethamine (every third eligble patient allocated SP)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 831 0
Government body
Name [1] 831 0
US AID
Address [1] 831 0
Country [1] 831 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
RTI International
Address
Country
United States of America
Secondary sponsor category [1] 700 0
University
Name [1] 700 0
University of Western Australia
Address [1] 700 0
Country [1] 700 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2094 0
Jhapa District (Mechi Zonal Hospital)
Ethics committee address [1] 2094 0
Ethics committee country [1] 2094 0
Nepal
Date submitted for ethics approval [1] 2094 0
Approval date [1] 2094 0
Ethics approval number [1] 2094 0

Summary
Brief summary
To assess whether the existing treatment for uncomplicated malaria in eastern parts of the Terai in Nepal (supfadoxine-pyrimethamine) is still effective and to determine whether artemether-lumefantrine is a more effective alternative is a significant treatment failreu rate for SP is present
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35552 0
Address 35552 0
Country 35552 0
Phone 35552 0
Fax 35552 0
Email 35552 0
Contact person for public queries
Name 9874 0
Timothy Davis
Address 9874 0
School of Medicine and Pharmacology
University of Western Australia
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 9874 0
Australia
Phone 9874 0
+61 8 94313229
Fax 9874 0
+61 8 94312977
Email 9874 0
tdavis@cyllene.uwa.edu.au
Contact person for scientific queries
Name 802 0
Timothy Davis
Address 802 0
School of Medicine and Pharmacology
University of Western Australia
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 802 0
Australia
Phone 802 0
+61 8 94313229
Fax 802 0
+61 8 94312977
Email 802 0
tdavis@cyllene.uwa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results