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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
Scientific title
Efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in West Sumba District, East Nusatenggara Province, Indonesia
Secondary ID [1] 263019 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 270744 0
Condition category
Condition code
Infection 270922 270922 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269406 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] 279648 0
% 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).
Timepoint [1] 279648 0
At 28 day following treatment
Primary outcome [2] 279649 0
% 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.
Timepoint [2] 279649 0
At 28 day following treatment
Secondary outcome [1] 294122 0
Nil
Timepoint [1] 294122 0
Nil

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.
Minimum age
3 Years
Maximum age
65 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 * unable to or unwilling to take contraceptives

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 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.
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
Nil
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] 3834 0
Indonesia
State/province [1] 3834 0

Funding & Sponsors
Funding source category [1] 269877 0
Government body
Name [1] 269877 0
Eijkman Institute for Molecular Biology,
Address [1] 269877 0
Jalan Diponegoro 69,
Jakarta 10430, Indonesia
Country [1] 269877 0
Indonesia
Funding source category [2] 269878 0
Government body
Name [2] 269878 0
Malaria sub-directorate, Directorate General of Disease control and Environmental Sanitation
Address [2] 269878 0
Jl Percetakan Negara No 29, Building D, 2nd Floor,
Jakarta Pusat, Jakarta 10560, Indonesia
Country [2] 269878 0
Indonesia
Funding source category [3] 269879 0
Government body
Name [3] 269879 0
Ministry of Health Indonesia
Address [3] 269879 0
Jl Percetakan Negara No 29, Building D, 2nd Floor,
Jakarta Pusat, Jakarta 10560, Indonesia
Country [3] 269879 0
Indonesia
Primary sponsor type
Government body
Name
Malaria sub-directorate, Directorate General of Disease control and Environmental Sanitation
Address
Jl Percetakan Negara No 29, Building D, 2nd Floor,
Jakarta Pusat, Jakarta 10560, Indonesia
Country
Indonesia
Secondary sponsor category [1] 268895 0
None
Name [1] 268895 0
Address [1] 268895 0
Country [1] 268895 0
Other collaborator category [1] 252261 0
Other
Name [1] 252261 0
World Health Organization Indonesia Country office
Address [1] 252261 0
Bina Mulia I, Floor 9. Jl.
HR. Rasuna Said Kav. 10-11 Kuningan Jakarta 12950
Country [1] 252261 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271845 0
Eijkman Institute Research Ethics Commission
Ethics committee address [1] 271845 0
Jalan Diponegoro 69, Jakarta 10430, Indonesia
Ethics committee country [1] 271845 0
Indonesia
Date submitted for ethics approval [1] 271845 0
28/06/2011
Approval date [1] 271845 0
29/07/2011
Ethics approval number [1] 271845 0
Project number 48

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.
Trial website
Trial related presentations / publications
No trial presentations/publications yet
Public notes

Contacts
Principal investigator
Name 33138 0
Dr Din Syafruddin
Address 33138 0
Institution: Eijkman Institute for Molecular Biology, Jalan Diponegoro 69, Jakarta 10430, Indonesia
Country 33138 0
Indonesia
Phone 33138 0
+62 21 3917131
Fax 33138 0
Email 33138 0
din@eijkman.go.id
Contact person for public queries
Name 16385 0
Dr Din Syafruddin, M.D., Ph.D.
Address 16385 0
Institution: Eijkman Institute for Molecular Biology,
Jalan Diponegoro 69, Jakarta 10430, Indonesia
Country 16385 0
Indonesia
Phone 16385 0
+62 21 3917131
Fax 16385 0
+62 1 3147982
Email 16385 0
din@eijkman.go.id
Contact person for scientific queries
Name 7313 0
Dr Din Syafruddin, M.D., Ph.D.
Address 7313 0
Institution: Eijkman Institute for Molecular Biology,
Jalan Diponegoro 69, Jakarta 10430, Indonesia
Country 7313 0
Indonesia
Phone 7313 0
+62 21 3917131
Fax 7313 0
+62 1 3147982
Email 7313 0
din@eijkman.go.id

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