Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001092886
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
12/10/2012
Date last updated
12/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic Efficacy Testing of artemether-lumefantrine for the treatment of uncomplicated plasmodium falciparum malaria infection in mainland Tanzania
Scientific title
Therapeutic Efficacy Testing of artemether-lumefantrine for the treatment of uncomplicated plasmodium falciparum infection in mainland Tanzania
Secondary ID [1] 281162 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287327 0
Condition category
Condition code
Infection 287666 287666 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evaluating the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in Tanzania. Drug will be administered orally using a 6-dose regimen of artemether-lumefantrine (a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) twice a day for 3 days. (Patient weighing 5-14kg - one tablet, patients weighing 15-24kg - two tablets, patients weighing 25-35kg - 3 tablets).
Intervention code [1] 285611 0
Treatment: Drugs
Comparator / control treatment
N/A -is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287910 0
Percent of artemether-lumefantrine treatment failure (early treatment failure, late clinical failure, late parasitological failure).

Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.
Timepoint [1] 287910 0
at day 28 following treatment
Secondary outcome [1] 299041 0
Percentage of adverse events in all enrolled patients will be documented. Parents or guardians of all enrolled patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form.

Possible medicine related adverse effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus and increased hair loss, macular rash, reduction in neutrophil counts and convulsions. However, it is likely that many of these effects are disease-related rather than medicine-induced.
Timepoint [1] 299041 0
at day 28 following treatment

Eligibility
Key inclusion criteria
1. Patients aged 6- months-10 years.
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of greater than or equal to 250/microlitre asexual forms;
4. presence of axillary temperature greater than or equal to 37.5 degrees celsius or history of fever during the past 24 hours
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; and
7. Informed consent from the parent or guardian of children.
Minimum age
6 Months
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of general danger signs in children aged 6 months-10 years or signs of severe falciparum malaria according to the definitions of WHO;
2. mixed or mono-infection with another Plasmodium species detected by microscopy;
3. 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 of less than 110 mm);
4. 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);
5. regular medication, which may interfere with antimalarial pharmacokinetics;
6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

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 with uncomplicated malaria, who meet the study inclusion criteria will be enrolled, treated on site with artemether-lumefantrine and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations.
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 the test drug.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment outside Australia
Country [1] 4531 0
Tanzania, United Republic Of
State/province [1] 4531 0

Funding & Sponsors
Funding source category [1] 285938 0
Other Collaborative groups
Name [1] 285938 0
USAID
Country [1] 285938 0
United States of America
Funding source category [2] 285939 0
Other Collaborative groups
Name [2] 285939 0
World Health Organization
Country [2] 285939 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health of Tanzania
Address
P.O. Box 9083
Dar es Salaam
Country
Tanzania, United Republic Of
Secondary sponsor category [1] 284762 0
None
Name [1] 284762 0
Address [1] 284762 0
Country [1] 284762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287967 0
National Institute for Medical Research
Ethics committee address [1] 287967 0
P.O. Box 9653
Dar es Salaam
Ethics committee country [1] 287967 0
Tanzania, United Republic Of
Date submitted for ethics approval [1] 287967 0
04/03/2012
Approval date [1] 287967 0
03/05/2012
Ethics approval number [1] 287967 0
NIMH/HQ/R.8c/Vol. I/205
Ethics committee name [2] 287968 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 287968 0
Avenue Appia 20
1211 Geneva 27
Ethics committee country [2] 287968 0
Switzerland
Date submitted for ethics approval [2] 287968 0
24/07/2012
Approval date [2] 287968 0
28/08/2012
Ethics approval number [2] 287968 0
RPC533

Summary
Brief summary
Therapeutic Efficacy Testing of artemether-lumefantrine for the treatment of uncomplicated plasmodium falciparum infection in mainland Tanzania
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34663 0
Address 34663 0
Country 34663 0
Phone 34663 0
Fax 34663 0
Email 34663 0
Contact person for public queries
Name 17910 0
Dr Abdunoor Mulokozi Kabanywanyi
Address 17910 0
Ifakara Health Institute
Dar es Salaam office
P O Box 78373, Plot 463, Kiko Ave, Mikocheni
Dar es Salaam
Country 17910 0
Tanzania, United Republic Of
Phone 17910 0
+255 222 774 714
Fax 17910 0
Email 17910 0
[email protected]
Contact person for scientific queries
Name 8838 0
Dr Abdunoor Mulokozi Kabanywanyi
Address 8838 0
Ifakara Health Institute
Dar es Salaam office
P O Box 78373, Plot 463, Kiko Ave, Mikocheni
Dar es Salaam
Country 8838 0
Tanzania, United Republic Of
Phone 8838 0
+255 222 774 714
Fax 8838 0
Email 8838 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
No additional documents have been identified.