Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001246976
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 Plasmodium falciparum malaria, and chloroquine for P. vivax in Bamaw (Kachin State) and Loikaw (Kayah State).
Scientific title
Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for P. vivax in Bamaw (Kachin State) and Loikaw (Kayah State).
Secondary ID [1] 273508 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 279308 0
Condition category
Condition code
Infection 279500 279500 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): 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] 283824 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] 286064 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] 286064 0
At 28 day following artemether-lumefantrine or chloroquine treatment or at 42 day following artesunate-mefloquine treatment.
Primary outcome [2] 286065 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] 286065 0
At 28 day following artemether-lumefantrine or chloroquine treatment or at 42 day following artesunate-mefloquine treatment.
Secondary outcome [1] 295063 0
Nil
Timepoint [1] 295063 0
Nil

Eligibility
Key inclusion criteria
*age above 13 years inclusive except females aged 14-17 year old inclusive;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro liter asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/micro liter 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
14 Years
Maximum age
60 Years
Sex
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
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment outside Australia
Country [1] 3989 0
Myanmar
State/province [1] 3989 0

Funding & Sponsors
Funding source category [1] 284301 0
Government body
Name [1] 284301 0
Ministry of defense
Country [1] 284301 0
Myanmar
Primary sponsor type
Government body
Name
Defense Services General Hospital, Ministry of defense
Address
Ministry of Defense
Clinical Research Unit (Malaria)
Defense Services General Hospital
Mingalardon, Yangon, Myanmar
Country
Myanmar
Secondary sponsor category [1] 283247 0
None
Name [1] 283247 0
Address [1] 283247 0
Country [1] 283247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286261 0
Medical EThical Committee
Ethics committee address [1] 286261 0
Ministry of Defence,
Directorate of Medical Services,
No. (1) Defence Services general Hospital (1000 beds),
Mingalardon, Myanmar
Ethics committee country [1] 286261 0
Myanmar
Date submitted for ethics approval [1] 286261 0
Approval date [1] 286261 0
29/09/2011
Ethics approval number [1] 286261 0
01/Ethics/11
Ethics committee name [2] 286262 0
Ethical Review Committee , World Health Organization (ERC, WHO)
Ethics committee address [2] 286262 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [2] 286262 0
Switzerland
Date submitted for ethics approval [2] 286262 0
14/10/2011
Approval date [2] 286262 0
08/11/2011
Ethics approval number [2] 286262 0
RPC485

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
Public notes

Contacts
Principal investigator
Name 33471 0
Address 33471 0
Country 33471 0
Phone 33471 0
Fax 33471 0
Email 33471 0
Contact person for public queries
Name 16718 0
Dr. Khin Phyu Pyar
Address 16718 0
Head of Clinical Research Unit (Malaria)
No. (1) Defence Services General Hospital (1000 bedded), Mingaladon.
Country 16718 0
Myanmar
Phone 16718 0
+951-03135195
Fax 16718 0
Email 16718 0
[email protected]
Contact person for scientific queries
Name 7646 0
Dr. Khin Phyu Pyar
Address 7646 0
Head of Clinical Research Unit (Malaria)
No. (1) Defence Services General Hospital (1000 bedded), Mingaladon.
Country 7646 0
Myanmar
Phone 7646 0
+951-03135195
Fax 7646 0
Email 7646 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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