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Trial registered on ANZCTR


Registration number
ACTRN12618001569291
Ethics application status
Approved
Date submitted
7/06/2018
Date registered
19/09/2018
Date last updated
19/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and Safety of Artemether- Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Selected Upazila of Chittagong Hill Tracts (CHT), Bangladesh
Scientific title
Therapeutic Efficacy and safety of anti-malarial drug artemether-lumefantrine in uncomplicated Plasmodium falciparum infected patients in CHT of Bangladesh
Secondary ID [1] 295128 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
TES (Therapeutic Efficacy Study)
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Resistance status of uncomplicated P. falciparum malaria against Artemether-lumefantrine 308216 0
Fever 308219 0
uncomplicated P.falciparum parasite 308223 0
Condition category
Condition code
Infection 307249 307249 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral tablet of AL (one tablet contains Artemether 20 mg+Lumefantrine 120mg), given according to body weight, twice daily for 3 days. Laboratory tests such as daily blood smear from Day 0 to Day 3 and weekly up to Day 28 are done to monitor treatment response over a 28-day period.
Intervention code [1] 301458 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306205 0
Parasitological efficacy of Artemether-Lumefantrine by blood sample microscopy
Timepoint [1] 306205 0
Day 3 after treatment or post intervention for early treatment failure (ETF)
Primary outcome [2] 306207 0
Recrudescence from new infection will be differentiated by polymerase chain reaction (PCR) analysis by blood smears in Whattman filter paper
Timepoint [2] 306207 0
Blood smears are assessed weekly between day 3 and 28 .
Secondary outcome [1] 351187 0
Death
Timepoint [1] 351187 0
within 6 months
Secondary outcome [2] 351188 0
Life Threatening situation in Case Report form of Serious adverse event report form
Timepoint [2] 351188 0
Within 28 days

Eligibility
Key inclusion criteria
The followings are the inclusion criteria for the study:
1. age more than 6 months;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000/µl to 100,000 asexual forms;
4. presence of axillary temperature equal to 37.5 °C or history of fever during the past 48 h;
5. ability to swallow oral medication;
6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
7. informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years;
8. informed assent from any minor participant aged from 12 to 18 and
9. consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of majority years.

Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of one or more of the following conditions will be the exclusion criteria for the study:
• presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO .
• weight under 5 kg;
• any mixed or mono-infection with other Plasmodium species detected by microscopy;
• presence of severe malnutrition defined as a child aged 6 to 60 months who has symmetrical oedema involving at least the feet and/or has a mid-upper arm circumference less than 115 mm)
• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV and 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; and
• Unable to or unwilling to take pregnancy test or to use contraception for married women of child-bearing age.
• Minors (below 18 years of age) who have achieved menarche will be excluded from the study.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/05/2018
Date of last participant enrolment
Anticipated
15/11/2018
Actual
Date of last data collection
Anticipated
14/12/2018
Actual
Sample size
Target
120
Accrual to date
54
Final
Recruitment outside Australia
Country [1] 10536 0
Bangladesh
State/province [1] 10536 0
Chittagong

Funding & Sponsors
Funding source category [1] 299720 0
Government body
Name [1] 299720 0
Ministry of Health and Family Affairs
Country [1] 299720 0
Bangladesh
Funding source category [2] 300166 0
Other
Name [2] 300166 0
World Health Organization
Country [2] 300166 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health and Family Affairs
Address
Bangladesh Secretariat, Abdul Gani Road, Dhaka-1000, Bangladesh
Country
Bangladesh
Secondary sponsor category [1] 299058 0
Other Collaborative groups
Name [1] 299058 0
World Health Organization
Address [1] 299058 0
10, United House, Gulshan Avenue, Gulshan -2, Dhaka-1212, Bangladesh
Country [1] 299058 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300608 0
Bangladesh Medical Research Council
Ethics committee address [1] 300608 0
BMRC Bhaban, Mohakhali, Dhaka-1212, Bangladesh
Ethics committee country [1] 300608 0
Bangladesh
Date submitted for ethics approval [1] 300608 0
15/02/2018
Approval date [1] 300608 0
22/02/2018
Ethics approval number [1] 300608 0
BMRC/NREC/2016-2019/502

Summary
Brief summary
Malaria is one of the major public health problems in Bangladesh. Out of 64 districts in the country malaria is endemic in 13 districts and 13.25 million people are at risk of the disease. Artemether-lumefantrine is the first-line drug for the treatment uncomplicated falciparum malaria. High degree of resistance of P. falciparum against chloroquine was found in the country. The wide scale use of the treatment regimen started in 2007. This study will help to measure the efficacy of artemether-lumefantrine in the treatment of uncomplicated plasmodium malaria in Bangladesh.
The objective of the study is to assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in Ramgarh Upazila of Khagrachori district and Nykhonchori Upazila of Bandarban district in Bangladesh. The participants will be febrile people or with history of fever in the last 24 hours >6 months old with confirmed uncomplicated P. falciparum infection. Patients will be treated with 3 day-regimen of artemether-lumefantrine. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from July to December, 2016. The results of this study will be used to assist the National Malaria Control Programme of Bangladesh in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. The proportion of study subjects experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug(s). PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection. The population of interest consists of patients aged >6 months of age diagnosed with uncomplicated P. falciparum malaria attending the health complexes, and having given or whose parents or guardians (in case of children) have given an informed consent for study inclusion. The study will be conducted during the malaria transmission season from June to December 2016 with the actual data collection from July to October 2016. Safety will be assessed by recording the nature and incidence of adverse events and serious adverse events.
The principal investigator will ensure that the study protocol is strictly adhered to and that all data are collected and recorded correctly on the case report form During each visit of the PI, the completed forms will be collected, data will be entered into a database by double independent data entry, according to WHO standard procedures. At a confidence level of 95% and with a precision around the estimate of 5%, at least 73 subjects need to be included. With a 20% increase to allow losses to follow-up and withdrawals during the 28-day follow-up period, 60 subjects need to be included in each of the sentinel site. Data will be analyzed using two methods: the per protocol analysis and the survival analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84206 0
Dr Abu Nayeem Mohammad Sohel
Address 84206 0
Evaluator, Malaria & Parasitic Disease Control Unit, Directorate General of Health Services, Mohakhali, Dhaka-1212, Bangladesh
Country 84206 0
Bangladesh
Phone 84206 0
+880-1713009597
Fax 84206 0
+880-2-9884284
Email 84206 0
[email protected]
Contact person for public queries
Name 84207 0
Abu Nayeem Mohammad Sohel
Address 84207 0
Evaluator, Malaria & Parasitic Disease Control Unit, Directorate General of Health Services, Mohakhali, Dhaka-1212, Bangladesh
Country 84207 0
Bangladesh
Phone 84207 0
+880-1713009597
Fax 84207 0
+880-2-9884284
Email 84207 0
[email protected]
Contact person for scientific queries
Name 84208 0
Abu Nayeem Mohammad Sohel
Address 84208 0
Evaluator, Malaria & Parasitic Disease Control Unit, Directorate General of Health Services, Mohakhali, Dhaka-1212, Bangladesh
Country 84208 0
Bangladesh
Phone 84208 0
+880-1713009597
Fax 84208 0
+880-2-9884284
Email 84208 0
[email protected]

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No Supporting Document Provided



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