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Trial registered on ANZCTR


Registration number
ACTRN12611000427976
Ethics application status
Approved
Date submitted
14/04/2011
Date registered
27/04/2011
Date last updated
3/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapeutic Efficacy Testing For Artemether Lumefantrine in treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (Katete, Mansa and Chipata) in Zambia
Scientific title
Therapeutic Efficacy Testing For Artemether Lumefantrine in treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (Katete, Mansa and Chipata) in Zambia
Secondary ID [1] 260011 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 265672 0
Condition category
Condition code
Infection 265805 265805 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm prospective evaluation with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Eligible subjects will be treated with artemether-lumefantrine. All patients will be followed up for 28 days.

Dose regimen: artemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg bw: 3 tablets and greater than or equal to 35 kg body weight (bw): 4 tablets. All treatment will be orally taken tablets.
Intervention code [1] 264429 0
Treatment: Drugs
Comparator / control treatment
"N/A - This is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria".
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266558 0
% of artemether-lumefantrine treatment failures (early treatment failure+late clinical failure+late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).
Timepoint [1] 266558 0
At 28 day following treatment
Secondary outcome [1] 276027 0
% of adverse events (e.g. abdominal pain, nausea, vomiting, headache and dizziness) in the artemether-lumefantrine treated patients. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the case report form.
Timepoint [1] 276027 0
At 28 day following treatment

Eligibility
Key inclusion criteria
*age equal to or above 6 months excluding female aged 12 to 18 years;
*mono-infection with P. falciparum detected by microscopy;
*parasitaemia of 1,000 to 200,000/microlitre asexual forms; *presence of axillary equal to or more than 37.5 degrees centigrade 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
Gender
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 (WHO);
*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 below 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 Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(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;
*unable to or unwilling to take contraceptives for pregnancy negative 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)
Potential patients will be screened for inclusion/exclusion criteria. Once the patient meets all the enrolment criteria and a parent/guardian consented to participate in the study, the patient will be recruited in to the study. All antimalarial treatment doses will be given by a study team member under supervision. Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made on days 2, 3 and 7 and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, and 28.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a one arm prospective study in which all eligible patients are given test drug.
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)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3392 0
Zambia
State/province [1] 3392 0

Funding & Sponsors
Funding source category [1] 264904 0
Government body
Name [1] 264904 0
Ministry of Health
Address [1] 264904 0
Ndeke House,
P.O. Box 30205,
Lusaka.
Country [1] 264904 0
Zambia
Primary sponsor type
Government body
Name
Ministry of Health
Address
Ndeke House,
P.O. Box 30205,
Lusaka.
Country
Zambia
Secondary sponsor category [1] 264002 0
None
Name [1] 264002 0
Address [1] 264002 0
Country [1] 264002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266858 0
TDRC Ethics Review Committee
Ethics committee address [1] 266858 0
Tropical Disease Research Centre,
P.O. Box 71769
NDOLA
Ethics committee country [1] 266858 0
Zambia
Date submitted for ethics approval [1] 266858 0
16/02/2011
Approval date [1] 266858 0
04/03/2011
Ethics approval number [1] 266858 0
TRC/C4/03/2011
Ethics committee name [2] 266859 0
World Health Organization Ethical Review Committee (WHO ERC)
Ethics committee address [2] 266859 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [2] 266859 0
Switzerland
Date submitted for ethics approval [2] 266859 0
21/03/2011
Approval date [2] 266859 0
04/04/2011
Ethics approval number [2] 266859 0
RPC445

Summary
Brief summary
Title: Therapeutic Efficacy Testing For Artemether Lumefantrine in treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (Katete, Mansa and Chipata) in Zambia.

Background: Therapeutic efficacy studies will be done in Zambia to assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria. The participants will be febrile people above 6 months except female aged 12-18, inclusive. Patients will be treated with artemether-lumefantrine twice a day over 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The results of this study will be used to assist the Ministry of Health of Zambia in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
There is trial related presentations/publications
Public notes

Contacts
Principal investigator
Name 32499 0
Mrs Busiku Hamainza
Address 32499 0
National Malaria Control Center Chainama Hospital College Grounds Lusaka
Country 32499 0
Zambia
Phone 32499 0
+260211282455
Fax 32499 0
Email 32499 0
bhamainza@nmcc.org.zm
Contact person for public queries
Name 15746 0
Mrs Busiku Hamainza
Address 15746 0
National Malaria Control Center

Chainama Hospital College Grounds
Lusaka
Country 15746 0
Zambia
Phone 15746 0
+260211282455
Fax 15746 0
+260211282427
Email 15746 0
bhamainza@nmcc.org.zm
Contact person for scientific queries
Name 6674 0
Mrs Busiku Hamainza
Address 6674 0
National Malaria Control Center
Chainama Hospital College Grounds
Lusaka
Country 6674 0
Zambia
Phone 6674 0
+260211282455
Fax 6674 0
+260211282427
Email 6674 0
bhamainza@nmcc.org.zm

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary