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Trial registered on ANZCTR
Registration number
ACTRN12611000999932
Ethics application status
Approved
Date submitted
19/09/2011
Date registered
20/09/2011
Date last updated
4/04/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in West Sumba District, East Nusatenggara Province, Indonesia
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Scientific title
Efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in West Sumba District, East Nusatenggara Province, Indonesia
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Secondary ID [1]
263019
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malaria
270744
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Condition category
Condition code
Infection
270922
270922
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
One arm prospective evaluation with artesunate + amodiaquine given over 3 days for the treatment of uncomplicated Plasmodium falciparum malaria. Dose regimen: Oral tablets of artesunate 4 mg/kg + amodiaquine 10 mg/kg once daily for 3 consecutive days. Each dose administration will be observed and recorded.
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Intervention code [1]
269406
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Treatment: Drugs
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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".
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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% of artesunate-amodiaquine 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).
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Assessment method [1]
279648
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Timepoint [1]
279648
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At 28 day following treatment
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Primary outcome [2]
279649
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% of adverse events (e.g. weakness, headache, nausea, vomiting, abdominal pain, diarrhoea etc) in the artesunate-amodiaquine 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.
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Assessment method [2]
279649
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Timepoint [2]
279649
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At 28 day following treatment
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Secondary outcome [1]
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Nil
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Assessment method [1]
294122
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Timepoint [1]
294122
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Nil
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Eligibility
Key inclusion criteria
*age between 3 to 65 years old excluding minor female aged 12-17 years; *mono-infection with P. falciparum detected by microscopy. *presence of P. falciparum malaria asexual 500-200000/ microliter; *presence of axillary equal to or more than 37.5 degrees centigrade 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.
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Minimum age
3
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 * unable to or unwilling to take contraceptives
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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 treatments 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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Nil
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2011
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Actual
12/12/2011
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Date of last participant enrolment
Anticipated
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Actual
29/02/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3834
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Indonesia
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State/province [1]
3834
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Funding & Sponsors
Funding source category [1]
269877
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Government body
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Name [1]
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Eijkman Institute for Molecular Biology,
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Address [1]
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Jalan Diponegoro 69,
Jakarta 10430, Indonesia
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Country [1]
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Indonesia
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Funding source category [2]
269878
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Government body
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Name [2]
269878
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Malaria sub-directorate, Directorate General of Disease control and Environmental Sanitation
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Address [2]
269878
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Jl Percetakan Negara No 29, Building D, 2nd Floor,
Jakarta Pusat, Jakarta 10560, Indonesia
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Country [2]
269878
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Indonesia
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Funding source category [3]
269879
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Government body
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Name [3]
269879
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Ministry of Health Indonesia
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Address [3]
269879
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Jl Percetakan Negara No 29, Building D, 2nd Floor,
Jakarta Pusat, Jakarta 10560, Indonesia
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Country [3]
269879
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Indonesia
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Primary sponsor type
Government body
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Name
Malaria sub-directorate, Directorate General of Disease control and Environmental Sanitation
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Address
Jl Percetakan Negara No 29, Building D, 2nd Floor,
Jakarta Pusat, Jakarta 10560, Indonesia
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Country
Indonesia
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Secondary sponsor category [1]
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None
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Name [1]
268895
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Address [1]
268895
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Country [1]
268895
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Other collaborator category [1]
252261
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Other
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Name [1]
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World Health Organization Indonesia Country office
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Address [1]
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Bina Mulia I, Floor 9. Jl.
HR. Rasuna Said Kav. 10-11 Kuningan Jakarta 12950
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Country [1]
252261
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Indonesia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Eijkman Institute Research Ethics Commission
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Ethics committee address [1]
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Jalan Diponegoro 69, Jakarta 10430, Indonesia
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Ethics committee country [1]
271845
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Indonesia
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Date submitted for ethics approval [1]
271845
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28/06/2011
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Approval date [1]
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29/07/2011
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Ethics approval number [1]
271845
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Project number 48
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Summary
Brief summary
Title: Efficacy and safety of artesunate + amodiaquine for the treatment of uncomplicated Plasmodium falciparum infection in in Indonesia.
Background: Therapeutic efficacy studies will be done in Indonesia to assess the efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated falciparum malaria. The study will be conducted in West Sumba District, East Nusa Tenggara Province of Indonesia. The participants will be febrile people equal to or above 6 months , inclusive. Patients will be treated with artesunate-amodiaquine daily for 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 Indonesia, in assessing the current national treatment guidelines for uncomplicated P. falciparum.
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Trial website
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Trial related presentations / publications
No trial presentations/publications yet
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Public notes
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Contacts
Principal investigator
Name
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Dr Din Syafruddin
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Address
33138
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Institution: Eijkman Institute for Molecular Biology, Jalan Diponegoro 69, Jakarta 10430, Indonesia
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Country
33138
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Indonesia
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Phone
33138
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+62 21 3917131
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Fax
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Email
33138
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[email protected]
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Contact person for public queries
Name
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Dr Din Syafruddin, M.D., Ph.D.
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Address
16385
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Institution: Eijkman Institute for Molecular Biology,
Jalan Diponegoro 69, Jakarta 10430, Indonesia
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Country
16385
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Indonesia
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Phone
16385
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+62 21 3917131
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Fax
16385
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+62 1 3147982
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Email
16385
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[email protected]
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Contact person for scientific queries
Name
7313
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Dr Din Syafruddin, M.D., Ph.D.
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Address
7313
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Institution: Eijkman Institute for Molecular Biology,
Jalan Diponegoro 69, Jakarta 10430, Indonesia
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Country
7313
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Indonesia
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Phone
7313
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+62 21 3917131
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Fax
7313
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+62 1 3147982
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Email
7313
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[email protected]
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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.
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