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Trial registered on ANZCTR


Registration number
ACTRN12610001023044
Ethics application status
Approved
Date submitted
16/11/2010
Date registered
22/11/2010
Date last updated
3/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Keur Soce, district of Ndoffane and Guediawaye, district of Guediawaye, Senegal.
Scientific title
Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Keur Soce, district of Ndoffane and Guediawaye, district of Guediawaye, Senegal.
Secondary ID [1] 253058 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 258623 0
Condition category
Condition code
Infection 258767 258767 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm propective evaluation with asrtesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Illigible subjects will be treated in a sequential manner by artesunate-amodiaquine or artemether-lumefantrine. This means that patients will be enrolled in the artesunate-amodiaquine group and after the target sample is reach, the subsequent patients will be enrolled in the artemether-lumefantrine. All patients will be followed up for 28 days.

Dose regimen:

a. Artesunate 4 mg/kg + amodiaquine 10mg/kg once daily for 3 consecutive days.

b. Atemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince 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] 257582 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] 259629 0
% of artesunate-amodiaquine and 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] 259629 0
Timepoint: At 28 day following treatment
Primary outcome [2] 259630 0
% of adverse events in the artemether-lumefantrine treated groups. 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 [2] 259630 0
Timepoint: At 28 day following treatment
Secondary outcome [1] 266290 0
Nil
Timepoint [1] 266290 0
Nil

Eligibility
Key inclusion criteria
*age above 6 months except female minors aged 14 to 17 years inclusive.
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 1000-100,000/microliterl asexual forms) except at Mwali site 1000-200000/microliter;
*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 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);

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 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] 3029 0
Senegal
State/province [1] 3029 0

Funding & Sponsors
Funding source category [1] 258069 0
Government body
Name [1] 258069 0
Ministry of Health and Prevention of Senegal
Address [1] 258069 0
Rue Aime Cesaire

P.O. Box 4024 Dakar, Dakar - Senegal
Country [1] 258069 0
Senegal
Primary sponsor type
Government body
Name
Ministry of Health and Prevention of Senegal
Address
Rue Aime Cesaire

P.O. Box 4024 Dakar, Dakar - Senegal
Country
Senegal
Secondary sponsor category [1] 257260 0
None
Name [1] 257260 0
Address [1] 257260 0
Country [1] 257260 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260029 0
National Ethical Committee for Research and Health
Ethics committee address [1] 260029 0
Ethics committee country [1] 260029 0
Senegal
Date submitted for ethics approval [1] 260029 0
Approval date [1] 260029 0
07/10/2010
Ethics approval number [1] 260029 0
0042.78 MSP/DS/DER
Ethics committee name [2] 260064 0
Ethical Review Committee , World Health Organization (ERC, WHO)
Ethics committee address [2] 260064 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [2] 260064 0
Switzerland
Date submitted for ethics approval [2] 260064 0
08/09/2010
Approval date [2] 260064 0
20/10/2010
Ethics approval number [2] 260064 0
RPC417

Summary
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Senegal.

Background: Therapeutic efficacy studies will be done in Senegal to assess the efficacy and safety of artesunate-amodiaquine et artemether-lumefantrine for the treatment of uncomplicated falciparum malaria. The study will be conducted in Keur Soce (region de Kaolack) and Guediawaye (region de Dakar) of Senegal.

The participants will be febrile people above 6 months except female aged 14-17, inclusive. Patients will be treated with artesunate-amodiaquine daily for 3 days or 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 Senegal in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31895 0
Address 31895 0
Country 31895 0
Phone 31895 0
Fax 31895 0
Email 31895 0
Contact person for public queries
Name 15142 0
Dr Jean Louis A NDIAYE
Address 15142 0
Service de Parasitologie Medicale,
Faculty of Medecine,
University of Cheikh Antan de Dakar (UCAD)
P.O. Box 5005,
Dakar
Country 15142 0
Senegal
Phone 15142 0
+221 33 825 19 98
Fax 15142 0
+221 33 825 36 68
Email 15142 0
jlndiaye@yahoo.com
Contact person for scientific queries
Name 6070 0
Dr Jean Louis NDIAYE
Address 6070 0
Service de Parasitologie Medicale,
Faculty of Medecine,
University of Cheikh Antan de Dakar (UCAD)
P.O. Box 5005,
Dakar
Country 6070 0
Senegal
Phone 6070 0
+221 33 825 19 98
Fax 6070 0
+221 33 825 36 68
Email 6070 0
jlndiaye@yahoo.com

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