Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000217606
Ethics application status
Approved
Date submitted
10/01/2014
Date registered
28/02/2014
Date last updated
28/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring the therapeutic efficacy of antimalarial medicines across International borders of India.
Scientific title
A study evaluating the efficacy and safety of artemether lumefantrine for the treatment of uncomplicated plasmodium falciparum infections in Lunglei district (Mizoram); Changlang district (Arunachal Pradesh), Gomati district or Dhalai district (Tripura) in India.
Secondary ID [1] 283891 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 290876 0
Condition category
Condition code
Infection 291234 291234 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Artemether-lumefantrine will be administered orally twice daily to patients for 3 days. Adult patients (35kg and above) will receive dosage of 80 mg artemether and 480 mg lumefantrine twice daily for 3 days. For patients from 25 to 35 kg the dosage is 60mg artemether and 360 mg of lumefantrine twice daily for 3 days. For patients from 15 to 25 kg the dosage is 40mg artemether and 240 mg of lumefantrine twice daily for 3 days.
For patients from 5 to 15 kg the dosage is 20mg artemether and 120 mg of lumefantrine twice daily for 3 days.
The first dose will be administered at the health centre by a study nurse or clinician. Every day morning doses of medicine on day 0, 1and 2 will be administered under the supervision of a qualified staff. The subsequent second dose on each day will be given at home by a parent or guardian and will be monitored by study personnel through mobile phone call or home visits if the parent/guardian is not reachable by mobile phone. All the doses will be administered after meals.
Intervention code [1] 288566 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291231 0
The study end-point is the classification assigned to a patient. Valid study end-points include: treatment failure, completion of the follow-up period without treatment failure, loss to follow-up, withdrawal from study, and protocol violation. At all times, the well-being of the patient will take priority over his or her continuation in the study.Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.
Timepoint [1] 291231 0
A standard physical examination will be performed at baseline (day 0 before dosing) and on days 1, 2, 3, 7, 14, 21, 28, 35 and 42. A complete medical history, demographic information and contact details will be taken at baseline.
Secondary outcome [1] 306298 0
Nil
Timepoint [1] 306298 0
Nil

Eligibility
Key inclusion criteria
Age between 1 year to 65 years ; Mono infection with P. falciparum detected by microscopy, parasitaemia of (1000)–(100000)/microlitre asexual forms; presence of axillary great than or equal to 37.5 degrees celsius or history of fever during the past 48 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
1 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition, 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, 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); a positive pregnancy test or breastfeeding; and unable to or unwilling to take contraceptives (for 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)
Patients on site having malaria symptoms
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 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2014
Actual
10/01/2014
Date of last participant enrolment
Anticipated
9/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5743 0
India
State/province [1] 5743 0
Lunglei district (Mizoram)
Country [2] 5768 0
India
State/province [2] 5768 0
Changlang district (Arunachal Pradesh), bordering Myanmarh
Country [3] 5769 0
India
State/province [3] 5769 0
Gomati or Dhalai districts (Tripura) bordering Bangladesh

Funding & Sponsors
Funding source category [1] 288533 0
Charities/Societies/Foundations
Name [1] 288533 0
World Health Organization
Country [1] 288533 0
Switzerland
Primary sponsor type
Government body
Name
National Insititute of Malaria Research
Address
Indian Council of Medical Research
Sector 8
Dwarka
New Delhi 110 077
Country
India
Secondary sponsor category [1] 287244 0
None
Name [1] 287244 0
Nil
Address [1] 287244 0
Nil
Country [1] 287244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290398 0
Institutional Ethics Committee, National Institute of Malaria Research
Ethics committee address [1] 290398 0
Indian Council of Medical Research
Sector 8
Dwarka
New Delhi 110 077
Ethics committee country [1] 290398 0
India
Date submitted for ethics approval [1] 290398 0
03/05/2013
Approval date [1] 290398 0
03/06/2013
Ethics approval number [1] 290398 0
Ethics committee name [2] 290399 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 290399 0
Avenue Appia 20
1211 Geneve 20
Ethics committee country [2] 290399 0
Switzerland
Date submitted for ethics approval [2] 290399 0
17/09/2013
Approval date [2] 290399 0
03/12/2013
Ethics approval number [2] 290399 0
RPC591

Summary
Brief summary
To study the efficacy of antimalarial drugs in India
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45478 0
Dr Neena Valecha
Address 45478 0
Maulana Azad Medical College
Delhi University
1986 New Delhi
Country 45478 0
India
Phone 45478 0
+91-11-25307103-104
Fax 45478 0
Email 45478 0
[email protected]
Contact person for public queries
Name 45479 0
Dr Neelima Mishra
Address 45479 0
Maulana Azad Medical College,
Delhi University,
New Delhi 1986
Country 45479 0
India
Phone 45479 0
+91-11-25361090
Fax 45479 0
Email 45479 0
[email protected])
Contact person for scientific queries
Name 45480 0
Dr Neena Valecha
Address 45480 0
Maulana Azad Medical College, Delhi University,
New Delhi 1986
Country 45480 0
India
Phone 45480 0
+91-11-25307103-104
Fax 45480 0
Email 45480 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
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