Trial Review

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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
Sex
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
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
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
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.