Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000407998
Ethics application status
Not yet submitted
Date submitted
4/04/2011
Date registered
19/04/2011
Date last updated
19/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak and Ranong provinces of Thailand
Scientific title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak and Ranong provinces of Thailand
Secondary ID [1] 259908 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated falciparum malaria patients 265511 0
Condition category
Condition code
Infection 265663 265663 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Artemether-lumefantrine (Coartem 'Registered Trademark') combination. A total dose of artemether 2mg/kg and lumefantrine 12 mg/kg (One tablet contains 20 mg artemether and 120 mg lumefantrine) two times a day for three days will be given.
Intervention code [1] 264331 0
Treatment: Drugs
Comparator / control treatment
The study will be done in 2 sentinel sites. No control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266445 0
Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest World Health Organization (WHO) guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.
Timepoint [1] 266445 0
Day 1, 2, 3, 7, 14, 21, 28, 35 and 42
Secondary outcome [1] 273792 0
The incidence of any adverse event such as nausea, vomiting, diarrhea, etc. will be documented. All patients will be asked routinely about the previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form. Serious adverse events must be reported to the sponsor.
Timepoint [1] 273792 0
Day 1, 2, 3, 7, 14, 21, 28, 35 and 42

Eligibility
Key inclusion criteria
-Age 6 months and above;
-Mono-infection with Plasmodium falciparum detected by microscopy
-P. falciparum parasitaemia of 500-1000000/ul asexual forms
-presence of axillary or tympanic temperature equal or more than 37.5C or history of fever during the past 24 h
-Ability to swallow oral medication
-Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule and
-Informed consent from the patient or from a parent or guardian in the 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 of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO -mixed or mono-infection with another Plasmodium species detected by microscopy -presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference <110 mm) -presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases -Regular medication, which may interfere with antimalarial pharmacokinetics -history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment -Female of child-bearing potential with ages 12-17 years old inclusive -A positive pregnancy test or breastfeeding -Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age

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)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3335 0
Thailand
State/province [1] 3335 0
Ranong
Country [2] 3336 0
Thailand
State/province [2] 3336 0
Tak

Funding & Sponsors
Funding source category [1] 264794 0
Other
Name [1] 264794 0
World Health Organization
Country [1] 264794 0
Thailand
Primary sponsor type
Government body
Name
Bureau of Vector-Borne Diseases
Address
Department of Disease Control, Ministry of Public Health, Tiwanon Road, Muang District, Nonthaburi 11000
Country
Thailand
Secondary sponsor category [1] 263906 0
None
Name [1] 263906 0
Address [1] 263906 0
Country [1] 263906 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266767 0
The Ethical Committee for Research in Human Subjects
Ethics committee address [1] 266767 0
Department of Disease Control, Ministry of Public Health, Tiwanon Road, Muang District, Nonthaburi 11000
Ethics committee country [1] 266767 0
Thailand
Date submitted for ethics approval [1] 266767 0
07/04/2011
Approval date [1] 266767 0
Ethics approval number [1] 266767 0

Summary
Brief summary
Title: Efficacy and safety of artemether+lumefrantine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak and Ranong provinces in Thailand
Background: Current first-line treatment for P. falciparum in Thailand is a 3-day artesunate-mefloquine combination. The second-line treatment is 7-day quinine-doxycycline combination. Study conducted in 2008 in 5 sentinel sites revealed high efficacy of the 3-day artesunate-mefloquine combination (96.8-100%). In 2009, the efficacy of the artesunate-mefloquine combination declined to 87-92.7% in 4 sentinel sites. The monitoring the efficacy of the first line treatment to generate valuable information for updating the national treatment policy is critical.
Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak, and Ranong provinces of Thailand
Methods: Antimalarial drug efficacy trials will be conducted in 2 sites for uncomplicated falciparum infection. The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. falciparum infection. Falciparum malaria patients will be treated with Artemether-lumefantrine (Coartem 'Registered Trademark') combination. A total dose of artemether 2mg/kg and lumefantrine 12 mg/kg two times a day for three days. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy for falciparum malaria. The study will be conducted from May 2011 - May 2012. The results of this study will be used to assist the Ministry of Public Health of Thailand in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32432 0
Address 32432 0
Country 32432 0
Phone 32432 0
Fax 32432 0
Email 32432 0
Contact person for public queries
Name 15679 0
Dr. Kanungnit Congpuong
Address 15679 0
Bureau of Vector-Borne Disease,
Department of Disease Control,
Ministry of Public Health,
Tiwanon Road, Muang District,
Nonthaburi, 11000
Country 15679 0
Thailand
Phone 15679 0
662 965 9608
Fax 15679 0
662 591 8422
Email 15679 0
kanungnitcongpuong@ymail.com
Contact person for scientific queries
Name 6607 0
Dr. Kanungnit Congpuong
Address 6607 0
Bureau of Vector-Borne Disease,
Department of Disease Control,
Ministry of Public Health,
Tiwanon Road, Muang District,
Nonthaburi, 11000
Country 6607 0
Thailand
Phone 6607 0
662 965 9608
Fax 6607 0
662 591 8422
Email 6607 0
kanungnitcongpuong@ymail.com

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.