Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001038886
Ethics application status
Approved
Date submitted
26/09/2012
Date registered
28/09/2012
Date last updated
28/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in selected districts of Nepal
Scientific title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in selected districts of Nepal
Secondary ID [1] 281305 0
NEP/TES/MAL/2012-1; version 3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uncomplicated falciparum malaria 287511 0
Condition category
Condition code
Infection 287840 287840 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment with artemether lumefantrine will be given orally in 6 doses twice daily over 3 days as per standard of care in Nepal. Each tablet contains 20 mg of artemether and 120 mg of lumefantrine. The number of tablets to be administered at each dose will be based on body weight (5-14 kg = 1 tablet; 15-24 kg = 2 tablets, 25-34 kg = 3 tablets and, 35 kg and over = 4 tablets). All patients will be confined in the hospital for three days and will return for efficacy and safety follow-up assessments at day 7, 14, 21 and 28 post-dosing.
Intervention code [1] 285767 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288059 0
Percent of treatment failures (early treatment failure + late clinical failure + late parasitological failure) as defined in the latest WHO protocol for monitoring antimalarial drug efficacy (WHO 2009)
Timepoint [1] 288059 0
Day 28 following initiation of treatment
Secondary outcome [1] 299352 0
Nature and incidence of adverse events that develops or worsens with the use of the medicinal product, regardless of whether it is related to the medicinal product. Possible adverse events include dizziness, tching, vomiting, abdominal pain, flatulence, headache, body ache, diarrhoea, tinnitus, increased hair loss, macular rash, reduction in neutriophil counts, and convulsions. However, it is likely that many of these effects are disease-related rather than associated to the use of the antimalarial drug.
Timepoint [1] 299352 0
Day 28 following initiation of treament.

Eligibility
Key inclusion criteria
Patients above 6 months, except girls between 12-18 years and unmarried women above 18 years
Malaria positive p. falciparum mono-infection with a parasite density of 1'000-100'000 parasites per microliter
Axillary temperature of 37.5 C or greater or history of fever during the past 24 hours
Ability to swallow oral medication
Ability to comply with study procedures
Written informed consent from patient or from parent or leagl guardian in case of children
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence general danger signs of severe and complicated malaria
Mixed or mono-infection with another Plasmodium species
Severe malnutrition
Febrile conditions due to disease other than malaria
Regular medication, whcih may interfere with antimalarial pharmacokinetics.
History of hypersensitivity reactions to the medicinal products
preganancy or breastfeeding
Girls between 12-18 years, or unamrried women above 18 years
Women unable or unwilling to take contraceptives

Study design
Purpose
Natural history
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment outside Australia
Country [1] 4571 0
Nepal
State/province [1] 4571 0

Funding & Sponsors
Funding source category [1] 286061 0
Government body
Name [1] 286061 0
World Health Organisation
Country [1] 286061 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health and Population, Nepal
Address
Department of Health Services,
TEKU Business Park
Kathmandou 44600
Kathmandu
Country
Nepal
Secondary sponsor category [1] 284873 0
None
Name [1] 284873 0
Address [1] 284873 0
Country [1] 284873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288111 0
WHO ERC
Ethics committee address [1] 288111 0
20 Avenue Appia
CH1211 Geneva 27
Ethics committee country [1] 288111 0
Switzerland
Date submitted for ethics approval [1] 288111 0
Approval date [1] 288111 0
25/09/2012
Ethics approval number [1] 288111 0
RPC539

Summary
Brief summary
To monitor the efficacy of artemether-lumefantrine in the treament of uncomplicated falciparum malaria in three sentinel sites in Nepal
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34758 0
Address 34758 0
Country 34758 0
Phone 34758 0
Fax 34758 0
Email 34758 0
Contact person for public queries
Name 18005 0
Dr Gabrib Das Thakur
Address 18005 0
Director, Epidemiology & Diesease Control Division
Department of Health Services
TEKU Business Park
Kathmandu 44600
Kathmandu
Country 18005 0
Nepal
Phone 18005 0
+ 977 1 426 2268
Fax 18005 0
Email 18005 0
[email protected]
Contact person for scientific queries
Name 8933 0
Dr Gabrib Das Thakur
Address 8933 0
Director, Epidemiology & Diesease Control Division
Department of Health Services
TEKU Business Park
Kathmandu 44600
Kathmandu
Country 8933 0
Nepal
Phone 8933 0
+ 977 1 426 2268
Fax 8933 0
Email 8933 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.