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Trial registered on ANZCTR


Registration number
ACTRN12610000896077
Ethics application status
Approved
Date submitted
19/10/2010
Date registered
21/10/2010
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of artesunate 7days therapy for the treatment of
uncomplicated Plasmodium falciparum malaria in Kawthaung
(Tanintharyi Division) in Myanmar.
Scientific title
Efficacy of artesunate 7days therapy for the treatment of
uncomplicated Plasmodium falciparum malaria in Kawthaung
(Tanintharyi Division) in Myanmar.
Secondary ID [1] 252910 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 258446 0
Condition category
Condition code
Infection 258610 258610 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm propective evaluation with artesunate 4 mg/day over 7 days for the treatment of uncomplicated Plasmodium falciparum malaria.

Dose regimen:
artesunate tablets (Tablet containing 50 mg): 4mg/kg/day
for 7 days. Each dose administration will be observed and recorded.
Intervention code [1] 257440 0
Treatment: Drugs
Comparator / control treatment
A one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259459 0
% of artesunate treatment failures (early treatment failure+late clinical failure+late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).
Timepoint [1] 259459 0
At 28 day following treatment
Secondary outcome [1] 266015 0
% of adverse events in the artesunate treated groups. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the case report form.
Timepoint [1] 266015 0
At 28 day following treatment

Eligibility
Key inclusion criteria
*age equal to or more than 18 years;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 1000-100000/microliterl asexual forms;
*presence of axillary equal to or more than 37.5 degrees centigrade 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
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*presence signs of severe falciparum malaria according to the definitions of World Health Organization (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 below 110 mm);
*presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(HIV/AIDS);
*regular medication, which may interfere with antimalarial pharmacokinetics;
*history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
a positive pregnancy test or breastfeeding (include this criterion only if adults are included);
*unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);
*previous antimalarial drug intake in the past 48 hours;
*patients presenting with splenectomy.

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)
Potential patients will be screened for inclusion/exclusion criteria. Once the patient meets all the enrolment criteria and sh/she consented to participate in the study, the patient will be recruited in to the study. All antimalarial treatment will be given by a study team member under supervision. Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made on days 2, 3 and 7 and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, and 28.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a one arm prospective study in which all eligible patients are given test drug.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 2982 0
Myanmar
State/province [1] 2982 0

Funding & Sponsors
Funding source category [1] 257880 0
Government body
Name [1] 257880 0
Department of Medical Research (Lower Myanmar)
Address [1] 257880 0
No.5, Ziwaka Road, Dagon
P.O. Yangon 11191
Country [1] 257880 0
Myanmar
Primary sponsor type
Government body
Name
Department of Medical Research (Lower Myanmar)
Address
No.5, Ziwaka Road, Dagon
P.O. Yangon 11191
Country
Myanmar
Secondary sponsor category [1] 257080 0
None
Name [1] 257080 0
Address [1] 257080 0
Country [1] 257080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259906 0
Ethical Review Committee , World Health Organization (ERC, WHO)
Ethics committee address [1] 259906 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [1] 259906 0
Switzerland
Date submitted for ethics approval [1] 259906 0
01/07/2010
Approval date [1] 259906 0
24/08/2010
Ethics approval number [1] 259906 0
RPC412
Ethics committee name [2] 260118 0
Department of medical Rsearch, Ministry of Health
Ethics committee address [2] 260118 0
No.5, Ziwaka Road, Dagon P.O. Yangon 11191
Ethics committee country [2] 260118 0
Myanmar
Date submitted for ethics approval [2] 260118 0
Approval date [2] 260118 0
21/06/2010
Ethics approval number [2] 260118 0
15/Ethics 2010

Summary
Brief summary
Title: Efficacy of artesunate 4 mg/day over 7 days for the treatment of uncomplicated Plasmodium falciparum
malaria in Kawthaung (Tanintharyi Division) in Myanmar.

Background: The artemisinin resistance is not just on the Thai-Cambodia border, but may have extended to or
emerged on the Thai-Myanmar, China-Myanmar and Cambodia-Viet Nam borders, confirmatory artemisinin
monotherapy in vivo studies and molecular fingerprinting of parasite genomes to track artemisinin resistance
(gene flow) moving around the region is even more important now. Of the data presented from these countries,
the slow parasite clearance time (PCT) following treatment with artemisinin derivatives was of greatest
concern. With combination therapy, artesunate usually provides the initial rapid decrease of PCT, with 95% of
patients clearing peripheral parasitaemia within 48 hours, hence if the PCT is slow despite the drug being in the
blood at adequate levels, this could provide evidence that it is failing.

Objective: To assess the efficacy of artesunate 4 mg/day over 7 days for the treatment of uncomplicated
Plasmodium falciparum malaria in Kawthaung (Tanintharyi Division) in Myanmar.
Methods: An antimalarial drug efficacy trial will be conducted in Kawthaung (Tanintharyi Division),
Mzanmar. The participants will be febrile people > 18 years with confirmed uncomplicated P. falciparum
infection. Patients will be treated with artesunate 28 mg/kg over 7 days. Clinical and parasitological parameters
will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from
October to December 2010. The results of this study will be used to assist the Ministry of Health of Myanmar in
assessing the current national treatment guidelines for uncomplicated P. falciparum malaria and mapping the
extent of artesunate resistance.
Trial website
Trial related presentations / publications
Trial related presentations/publications are not available
Public notes

Contacts
Principal investigator
Name 31804 0
Dr Myat-Phone-Kyaw
Address 31804 0
Research Division, Department of Medical Research (Lower Myanmar). No.5, Ziwaka Road, Dagon P.O. Yangon 11191, Myanmar
Country 31804 0
Myanmar
Phone 31804 0
+951-3754 47, +951375449, +951-375457
Fax 31804 0
Email 31804 0
myat@mptmail.net.mm
Contact person for public queries
Name 15051 0
Dr Dr. Myat-Phone-Kyaw
Address 15051 0
Research Division, Department of Medical Research (Lower Myanmar).
No.5, Ziwaka Road, Dagon P.O. Yangon 11191, Myanmar
Country 15051 0
Myanmar
Phone 15051 0
+951-3754 47, 951375449, 951-375457
Fax 15051 0
951 251514
Email 15051 0
myat@mptmail.net.mm
Contact person for scientific queries
Name 5979 0
Dr Dr. Myat-Phone-Kyaw
Address 5979 0
Research Division, Department of Medical Research (Lower Myanmar).
No.5, Ziwaka Road, Dagon P.O. Yangon 11191, Myanmar
Country 5979 0
Myanmar
Phone 5979 0
+951-3754 47, 951375449, 951-375457
Fax 5979 0
951 251514
Email 5979 0
myat@mptmail.net.mm

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary