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Trial registered on ANZCTR


Registration number
ACTRN12612000935831
Ethics application status
Approved
Date submitted
30/08/2012
Date registered
3/09/2012
Date last updated
3/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh
Scientific title
Efficacy (adequate clinical and parasitological response-ACPR) as well failure (early treatment failure-ETF, late clinical failure-LCF, late parasitological failure-LPF) of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria patients in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh.
Secondary ID [1] 281126 0
Nil
Universal Trial Number (UTN)
U 1111-1132-5400
Trial acronym
TES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistance status of artemether-lumefantrine against uncomplicated P. falciparum malaria. 287296 0
Condition category
Condition code
Public Health 287626 287626 0 0
Other public health
Infection 287632 287632 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) Treatment with artemether-lumefantrine will be given as per the national drug regimen 6 doses over 3 days. After the first dose second dose will be taken 8 hours after. Then the remaining four doses will be taken 12 hourly. Each tablet contains 20 mg of artemether and 120 mg of lumefantrine.

b) Mode of Administration-Oral tablet
Intervention code [1] 285584 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287877 0
This study will help to measure the efficacy (adequate clinical and parasitological response-ACPR).

ACPR- absence of parasitaemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.

Above classification is on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest WHO guidelines.
Timepoint [1] 287877 0
Patients will be followed up on days 1, 2, 3, 7, 14, 21 and 28 or any other days if warranted.
Primary outcome [2] 287886 0
Failure (early treatment failure-ETF, late clinical failure-LCF, late parasitological failure-LPF) of artemether-lumefantrine in the treatment of uncomplicated plasmodium malaria in Bangladesh.

Early treatment failure:
1. danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia;
2. parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature;
3. parasitaemia on day 3 with axillary temperature greater than or equal to37.5 degree Centigrade ;
4. parasitaemia on day 3 more than or equal to 25% of count on day 0.

Late treatment failure:

a. Late clinical failure:
1. danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 (day 42) in patients who did not previously meet any of the criteria of early treatment failure;
2. presence of parasitaemia on any day between day 4 and day 28 with axillary temperature greater than or equal to 37.5 degree Centigrade in patients who did not previously meet any of the criteria of early treatment failure

b. Late parasitological failure:
presence of parasitaemia on any day between day 7 and day 28 with axillary temperature less than 37.5 degree Centigrade in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure


Above classifications are on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest WHO guidelines.

The PCR technique will be used to differentiate a recrudescence (same parasite strain) from a newly acquired infection (different parasite strain),
Timepoint [2] 287886 0
Patients will be followed up on days 1, 2, 3, 7, 14, 21 and 28 or any other days if warranted.
Secondary outcome [1] 298974 0
Adverse events and serious adverse events during follow up.

Examples;

1. Death
2. Life-threatening
3. Prolongation of hospitalization
4. Permanent disability

Adverse events will be assessed by direct questioning. An adverse event is defined as any unfavourable, unintended sign, symptom, syndrome or disease that develops or worsens with the use of a medicinal product, regardless of whether it is related to the medicinal product.
Timepoint [1] 298974 0
On days 1, 2, 3, 7, 14, 21 and 28 or any other days if warranted.
Secondary outcome [2] 298988 0
Withdrawal and drop out during follow up period.
Timepoint [2] 298988 0
On days 1, 2, 3, 7, 14, 21 and 28 or any other days if warranted.

Eligibility
Key inclusion criteria
1. All patients above 6 months of age except girls between 12-18 years and unmarried women;

2. Malaria positive P. falciparum mono-infection with parasite density of 1,000-100,000 parasites/micro-litre;

3. Axillary temperature > 37.5 degree Centigrade or history of fever during the past 24 hours;

4. Ability to swallow oral medication;

5. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;

6. 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
1. Presence of general danger signs or other signs of severe and complicated falciparum malaria according to current WHO definitions.

2. Mixed or mono-infection with another Plasmodium species detected by microscopy;

3. Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference < 110 mm)

4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);

5. Regular medication, which may interfere with antimalarial pharmacokinetics;

6. History of hypersensitivity reactions or contraindications to the medicine being tested;

7. A positive pregnancy test or breastfeeding;

8. Unmarried women and girls between 12-18 years;

9. Unable to or unwilling to take contraceptives (for 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment outside Australia
Country [1] 4517 0
Bangladesh
State/province [1] 4517 0

Funding & Sponsors
Funding source category [1] 285907 0
Other
Name [1] 285907 0
World Health Organization
Country [1] 285907 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health and Family Welfare
Address
Bangladesh Secretariat
Dhaka-1000
Country
Bangladesh
Secondary sponsor category [1] 284729 0
None
Name [1] 284729 0
Address [1] 284729 0
Country [1] 284729 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287937 0
Bangladesh Medical Research Council
Ethics committee address [1] 287937 0
Ethics committee country [1] 287937 0
Bangladesh
Date submitted for ethics approval [1] 287937 0
04/03/2012
Approval date [1] 287937 0
13/05/2012
Ethics approval number [1] 287937 0
BMRC/NREC/2010-2013/657

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34642 0
Address 34642 0
Country 34642 0
Phone 34642 0
Fax 34642 0
Email 34642 0
Contact person for public queries
Name 17889 0
Dr Mohammad Jahirul Karim
Address 17889 0
Deputy Programme Manager, Malaria & Parasitic Disease Control Unit, Directorate General of Health Services, Mohakhali, Dhaka-1212.
Country 17889 0
Bangladesh
Phone 17889 0
+880-172-7007000
Fax 17889 0
+880-2-8861642
Email 17889 0
jahirulkarim@gmail.com
Contact person for scientific queries
Name 8817 0
Dr Abu Nayeem Mohammad Sohel
Address 8817 0
Evaluator, Malaria & Parasitic Disease Control Unit, Directorate General of Health Services, Mohakhali, Dhaka-1212.
Country 8817 0
Bangladesh
Phone 8817 0
+880-171-3009597
Fax 8817 0
+880-2-8861642
Email 8817 0
nayeemdr@yahoo.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.