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Trial registered on ANZCTR


Registration number
ACTRN12611001245987
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
6/12/2011
Date last updated
6/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar
Scientific title
Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar
Secondary ID [1] 273507 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 279307 0
Condition category
Condition code
Infection 279499 279499 0 0
Studies of infection and infectious agents

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

Dose regimen:
Aartemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg) will be given as follows: 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 body weight (bw): 3 tablets and greater than or equal to 35 kg bw: 4 tablets. All treatment will be orally taken tablets.

Artesunate-mefloquine tablets co-administered as artesunate 4mg/kg/day for three days + mefloquine 25 mg base/kg (split dose as 15mg/kg on day 0 followed by 10mg/kg on day 1).

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] 283823 0
Treatment: Drugs
Comparator / control treatment
N/A. This is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria and vivax malaria.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286062 0
% of artemether-lumefantrine, artesunate-mefloquine and chloroquine 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 World Health Organization (WHO) protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).
Timepoint [1] 286062 0
At 28 day following artemether-lumefantrine or chloroquine treatment or at 42 day following artesunate-mefloquine treatment.
Primary outcome [2] 286063 0
% of adverse events in the artemether-lumefantrine, artesunate-mefloquine and chloroquine 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 [2] 286063 0
At 28 day following artemether-lumefantrine or chloroquine treatment or at 42 day following artesunate-mefloquine treatment.
Secondary outcome [1] 295062 0
Nil
Timepoint [1] 295062 0
Nil

Eligibility
Key inclusion criteria
*age between 6 years inclusive and above except females aged 12-17 year old inclusive;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro l asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/micro literl asexual forms);
*presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours;
*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 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*presence of signs of severe falciparum malaria according to the definitions of World Health Organisation (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 Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (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, 28 (for artemether-lumefantrine and chloroquine) and 35 and 42 (for artesunate-mefloquine).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A. 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
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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] 3988 0
Myanmar
State/province [1] 3988 0

Funding & Sponsors
Funding source category [1] 284296 0
Government body
Name [1] 284296 0
Department of Medical Research (Upper Myanmar)
Address [1] 284296 0
Ward 16, Pyin Oo Lwin township, Mandalay Region, Myanmar
Country [1] 284296 0
Myanmar
Primary sponsor type
Government body
Name
Department of Medical Research (Upper Myanmar)
Address
Ward 16, Pyin Oo Lwin township, Mandalay Region, Myanmar
Country
Myanmar
Secondary sponsor category [1] 283246 0
None
Name [1] 283246 0
Address [1] 283246 0
Country [1] 283246 0
Other collaborator category [1] 260366 0
Government body
Name [1] 260366 0
Department of Medical Research (Lower Myanmar) & Department of Health
Address [1] 260366 0
No.5, Ziwaka Road, Dagon
P.O. Yangon 11191
Country [1] 260366 0
Myanmar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286258 0
Etical Committee on Medical Research Involving Human Subjects
Ethics committee address [1] 286258 0
Department of Medical Research (Upper Myanmar),
Ministry of Health,
Near the Anisakhan Airport, Pyin Oo Lwin Township, Myanmar.
Ethics committee country [1] 286258 0
Myanmar
Date submitted for ethics approval [1] 286258 0
Approval date [1] 286258 0
31/05/2011
Ethics approval number [1] 286258 0
2/Ethics 2011
Ethics committee name [2] 286259 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 286259 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [2] 286259 0
Switzerland
Date submitted for ethics approval [2] 286259 0
11/10/2011
Approval date [2] 286259 0
27/10/2011
Ethics approval number [2] 286259 0
RPC482

Summary
Brief summary
Title:Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar.

Background: Therapeutic efficacy studies will be done in Myanmar to assess the efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for the treatment of Plasmodium vivax.

Objective: Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated P. falciparum malaria, and chloroquine for the treatment of Plasmodium vivax in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region.

Methods: participants will be febrile people above 6 years with confirmed uncomplicated P. falciparum or P. vivax infection. Patients will be treated with artemether-lumefantrine twice a day over 3 days or artesunate-mefloquine over 3 days or chloroquine daily for 3 days. Clinical and parasitological parameters will be monitored either over a 28-day follow-up period to evaluate artemether-lumefantrine and chloroquine efficacies or over a 42-day follow-up to evaluate artesunate-mefloquine 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 malariaand vivax malaria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33470 0
Address 33470 0
Country 33470 0
Phone 33470 0
Fax 33470 0
Email 33470 0
Contact person for public queries
Name 16717 0
Dr Khin Lin
Address 16717 0
Director/Head
Parasitology Research Division
Department of Medical Research (Upper Myanmar)
Sithar village,
Ward Number(16)
East of Ani Sa Khan Airport
Pyin Oo Lwin township( Postal code 05061)
Mandalay Division
Country 16717 0
Myanmar
Phone 16717 0
+95-085-50438
Fax 16717 0
+95-085-90435
Email 16717 0
lin.khin@gmail.com
Contact person for scientific queries
Name 7645 0
Dr Marian Warsame
Address 7645 0
World Health Organization
20 Av. Appia,
1211 Geneva 27 Switzerland
Country 7645 0
Switzerland
Phone 7645 0
+41 22 791 5076
Fax 7645 0
+41 22 791 48 24
Email 7645 0
warsamem@who.int

No information has been provided regarding IPD availability
Summary results
No Results