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Trial registered on ANZCTR


Registration number
ACTRN12610000881033
Ethics application status
Approved
Date submitted
4/08/2010
Date registered
19/10/2010
Date last updated
4/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for P.vivax in Kyaing Tone (Eastern Shan State)
Scientific title
Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for P.vivax in Kyaing Tone (Eastern Shan State)
Secondary ID [1] 252613 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 257884 0
Condition category
Condition code
Infection 258046 258046 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm propective evaluation with: (i) artemether-lumefantrine and (ii) dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and (iii) with chloroquine for the treatment of Plasmodium vivax malaria. .

Dose regimen:
Atemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg bw: 3 tablets and greater than or equal to 35 kg body weight (bw): 4 tablets. All treatment will be orally taken tablets.

Dihydroartemisinin-piperaquine tablets (tablet containing dihydroartemisinin 40 mg/piperaquine phophate 320 mg): 2-2.4/16-19.2 mg/kg once a day for 3 days according to the following weight bands:11-18 kg body weight (bw): 1 tablet; 19-29 kg body weight (bw): 1 1/2 tablets; 30-39 kg body weight (bw): 2 tablets and greater than or equal to 40 kg body weight (bw): 3 tablets. All treatment will be orally taken tablets.

Chloroquine phophate tablets (tablet contains 150 mg base): 25 mg/kg body weight ober 3 consecutive days (10 mg/kg body weight on day 0, 10 mg/kg body weight (bw) on day 1 and 5 mg/kg body weight (bw) on day 2). All treatment will be orally taken tablets.
Intervention code [1] 256936 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] 258899 0
% of artemether-lumefantrine and of dihydroartemisinin-piperaquine 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] 258899 0
At 28 day following treatment
Primary outcome [2] 258900 0
% of chloroquine treatment failure (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 [2] 258900 0
At 28 day following treatment
Primary outcome [3] 258901 0
% of adverse events in the artemether-lumefantrine and dihydroartemisinin-piperaquine 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 [3] 258901 0
At 28 day following treatment
Secondary outcome [1] 265058 0
Nil
Timepoint [1] 265058 0
Nil

Eligibility
Key inclusion criteria
*age between 13 years inclusive and above except females aged 13-17 year old inclusive;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/microliterl asexual forms) or or P. vivax detected by microscopy (parasitaemia > 250/µl 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
13 Years
Maximum age
60 Years
Sex
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); and
*a positive pregnancy test or breastfeeding;
*unable to or unwilling to take a pregnancy test or contraceptives.

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 he/she or a parent/guardian (in case of children) 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
1/08/2010
Actual
10/08/2010
Date of last participant enrolment
Anticipated
Actual
13/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 2802 0
Myanmar
State/province [1] 2802 0

Funding & Sponsors
Funding source category [1] 257387 0
Government body
Name [1] 257387 0
Ministry of Defense
Country [1] 257387 0
Myanmar
Primary sponsor type
Government body
Name
Clinical Research Unit (Malaria), Ministry of Defense
Address
Clinical Research Unit (Malaria)
Defense Services General Hospital
Mingalardon, Yangon, Myanmar
Country
Myanmar
Secondary sponsor category [1] 256626 0
None
Name [1] 256626 0
Address [1] 256626 0
Country [1] 256626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259406 0
Ethical Review Committee , World Health Organization (ERC, WHO)
Ethics committee address [1] 259406 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [1] 259406 0
Switzerland
Date submitted for ethics approval [1] 259406 0
24/06/2010
Approval date [1] 259406 0
02/07/2010
Ethics approval number [1] 259406 0
RPC410
Ethics committee name [2] 259407 0
Medical EThical Committee, Ministry of defence
Ethics committee address [2] 259407 0
Ministry of Defence,
Directorate of Medical Services,
No. (1) Defence Services general Hospital (1000 beds),
Mingalardon, Myanmar

Tel+9503630859; Fax: +95067416055
Ethics committee country [2] 259407 0
Myanmar
Date submitted for ethics approval [2] 259407 0
Approval date [2] 259407 0
11/06/2010
Ethics approval number [2] 259407 0
01/Ethics/10

Summary
Brief summary
Title: Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria, and chloroquine for plasmodium vivax in Kyaing Tone (Eastern Shan State).
Background: Therapeutic efficacy studies will be done in Myanmar to assess the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria, and chloroquine for the treatment of Plasmodium vivax.

The participants will be febrile people above 13 years with confirmed uncomplicated P. falciparum. Patients will be treated with artemether-lumefantrine twice a day over 3 days or dihydroartemisinin-piperaquine over 3 days or chloroquine over 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. 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 and vivax malaria.
Trial website
Trial related presentations / publications
Trial related presentations/publications do not exist yet.
Public notes

Contacts
Principal investigator
Name 31469 0
Dr Khin Phyu Pyar
Address 31469 0
Head of Clinical Research Unit (Malaria)
No. (1) Defence Services General Hospital (1000 bedded), Mingaladon.
Country 31469 0
Myanmar
Phone 31469 0
+951-03135195
Fax 31469 0
Email 31469 0
[email protected]
Contact person for public queries
Name 14716 0
Dr. Khin Phyu Pyar
Address 14716 0
Head of Clinical Research Unit (Malaria)
No. (1) Defence Services General Hospital (1000 bedded), Mingaladon.
Country 14716 0
Myanmar
Phone 14716 0
+951-03135195
Fax 14716 0
Email 14716 0
[email protected]
Contact person for scientific queries
Name 5644 0
Dr. Khin Phyu Pyar
Address 5644 0
Head of Clinical Research Unit (Malaria)
No (1) Defence Services General Hospital (1000 bedded), Mingaladon.
Country 5644 0
Myanmar
Phone 5644 0
+951-03135195
Fax 5644 0
Email 5644 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.