Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000276257
Ethics application status
Approved
Date submitted
21/03/2009
Date registered
15/05/2009
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana
Scientific title
Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana
Secondary ID [1] 295382 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimalarial medicine efficacy 4514 0
Condition category
Condition code
Infection 4797 4797 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
artemether-lumefantrine, 20 mg artemether and 120 mg lumefantrine per tablet, malaria treatment, oral treatment 1 tablet for 5-14 kg, 2 tablets for 15-24 kg, 3 tablets 25-34, 4 tablets over 35 kg twice a day over 3 days
Intervention code [1] 4268 0
Treatment: Drugs
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5657 0
Clinical efficacy monitored by health care professionals by clinical eximaniation and temperature measurement and parasitological efficacy monitored by labortaory techniciansby thick blood smear
Timepoint [1] 5657 0
28 days post-testing initial treatment
Secondary outcome [1] 241910 0
Prevalence of side effects assessed by questionnaire
Timepoint [1] 241910 0
28 days post-testing initial treatment

Eligibility
Key inclusion criteria
age six months and above;
mono-infection with Plasmodium falciparum detected by microscopy;
parasitaemia of 500–200 000 asexual forms /microl blood;
presence of axillary temperature = 37.5 degre C and/or history of fever during the past 24 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
6 Months
Maximum age
60 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 World Health Organization;
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 < 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 immunodeficiency virus/acquired immunodeficiency syndrome);
regular medication, which may interfere with antimalarial pharmacokinetics;
history of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment(s); and
a positive pregnancy test or breastfeeding.

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
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2009
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
1/05/2009
Date of last data collection
Anticipated
Actual
30/05/2009
Sample size
Target
261
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 1695 0
Botswana
State/province [1] 1695 0

Funding & Sponsors
Funding source category [1] 4896 0
Government body
Name [1] 4896 0
Ministry of Health
Country [1] 4896 0
Botswana
Primary sponsor type
Government body
Name
Ministry of Health
Address
P/bag 00269 Gaborone
Country
Botswana
Secondary sponsor category [1] 4428 0
None
Name [1] 4428 0
Address [1] 4428 0
Country [1] 4428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6959 0
Ministry of Health
Ethics committee address [1] 6959 0
P/bag 00269 Gaborone
Ethics committee country [1] 6959 0
Botswana
Date submitted for ethics approval [1] 6959 0
Approval date [1] 6959 0
17/02/2009
Ethics approval number [1] 6959 0
PPME/13/18/1

Summary
Brief summary
To assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections among people older than 6 months in Chobe, Okavango and Tutume districts in Botswana.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29425 0
Dr Nesredin Jami Oumer
Address 29425 0
P/Bag 00269, Gaborone, Botswana
Country 29425 0
Botswana
Phone 29425 0
00267 363 2397
Fax 29425 0
Email 29425 0
Nesredin@gmail.com
Contact person for public queries
Name 12672 0
Dr Dr Ringwald Pascal
Address 12672 0
20 avenue Appia
1211 Geneva 27
Country 12672 0
Switzerland
Phone 12672 0
+ 41 22 791 34 69
Fax 12672 0
Email 12672 0
ringwaldp@who.int
Contact person for scientific queries
Name 3600 0
Dr Dr Ringwald Pascal
Address 3600 0
20 avenue Appia
1211 Geneva 27
Country 3600 0
Switzerland
Phone 3600 0
+ 41 22 791 34 69
Fax 3600 0
Email 3600 0
ringwaldp@who.int

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.