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Trial registered on ANZCTR


Registration number
ACTRN12615000171516
Ethics application status
Approved
Date submitted
14/11/2014
Date registered
20/02/2015
Date last updated
20/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pyronaridine-artesunate efficacy for the treatment of uncomplicated falciparum malaria in Cambodia
Scientific title
Pyronaridine-artesunate efficacy for the treatment of uncomplicated falciparum malaria in Cambodia
Secondary ID [1] 285660 0
071NECHR
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with plasmodium falciparum infection 293508 0
Condition category
Condition code
Infection 293787 293787 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is a single arm open label study to evaluation of the therapeutic efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated falciparum malaria. The eligible patients are treated with a daily dose of 1 tablet for 20-<24kg, 2 tablets for 24-<45 kg, 3 tablets for 45-<65kg and 4 tablets for 65 and above over 3 days. One tablet contains 60mg artesunate+18mg pyronaridine. Each dose is administered orally under the supervision of the medical doctor. A dose is repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only. The patients has a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). The patients has a weekly appointment over 42 days. If the patient do not attend for the follow-up a home-visitor from the study team will try to locate the patient and bring them to the study site.
Intervention code [1] 290602 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293584 0
The proportion of adequate clinical and parasitological response (ACPR) to the antimalarial treatment. A patient receives clinical examination and parastiological test for malaria on weekly basis over 42 days when the patient does not have malaria clinical manifestation and does not have malaria parasites in the blood the treatment outcome is classified as ACPR.
Timepoint [1] 293584 0
Day 42
Secondary outcome [1] 311403 0
The blood samples were collected to monitor the hepatic biological values (ALT, AST, total and conjugated bilirubin and alkaline phosphatase). These values are to be obtainable on day 0, 3, 7, 14, 21, 28, 35 and 42 by a liver function test machine at each study site.
Timepoint [1] 311403 0
at day 0, 3, 7,14,21,28,35 and 42

Eligibility
Key inclusion criteria
- Adults and children with body weight of 20 kg or above
- Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever 37.5 degree celcius or above
- Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
- Capability of taking an oral medication
Minimum age
10 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy or lactation (urine test for beta HCG to be performed on any woman of child bearing age, that is 18 to 45 years old)
- Female aged 12-18y
- Parasitemia less than 150 000/microlitre).
- Signs or symptoms indicative of severe malaria:
- Impaired consciousness (Blantyre Coma Score less than 5)
- Severe anaemia (Hct less than15%)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
- With the assumed efficacy of 90%, a sample size of 138 participants is needed for the study in three study sites for +/- 5% precision (this width is 0.1 in document), i.e., 85 to 95%. Allowing for a 5% drop out, we propose a sample size of 145 patients.

- Kaplan–Meier survival analysis
- Cox proportional hazards regression

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/08/2014
Actual
27/08/2014
Date of last participant enrolment
Anticipated
30/01/2015
Actual
31/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
145
Accrual to date
Final
Recruitment outside Australia
Country [1] 6496 0
Cambodia
State/province [1] 6496 0
Pailin
Country [2] 6497 0
Cambodia
State/province [2] 6497 0
Battambang
Country [3] 6498 0
Cambodia
State/province [3] 6498 0
Pursat

Funding & Sponsors
Funding source category [1] 290242 0
Government body
Name [1] 290242 0
National Centre for Parasitology, Entomology and Malaria Control
Country [1] 290242 0
Cambodia
Primary sponsor type
Other
Name
World Health Organization
Address
World Health Organization
20 Av. Appia, 1211 Geneva 27
Country
Switzerland
Secondary sponsor category [1] 288949 0
Government body
Name [1] 288949 0
The ministry of health
Address [1] 288949 0
No. 151-153, Kampuchea Krom Blvd (128), 12252 Phnom Penh
Country [1] 288949 0
Cambodia
Other collaborator category [1] 278233 0
University
Name [1] 278233 0
Mahidol Oxford Tropical Research Unit (MORU)
Faculty of Tropical Medicine, Mahidol University
Address [1] 278233 0
3/F 60th Anniversary Chalermprakiat Building, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand.
Country [1] 278233 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291945 0
National Ethics Committee for Health Research
Ethics committee address [1] 291945 0
Ethics committee country [1] 291945 0
Cambodia
Date submitted for ethics approval [1] 291945 0
06/03/2014
Approval date [1] 291945 0
28/03/2014
Ethics approval number [1] 291945 0
O71NECHR

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 238 238 0 0
/AnzctrAttachments/367427-Pyramax study 2014.pdf
Attachments [2] 239 239 0 0
/AnzctrAttachments/367427-Ethics Approval Letter.pdf

Contacts
Principal investigator
Name 52766 0
Dr Rithea Leang
Address 52766 0
National Centre for Parasitology, Entomology and Malaria Control Program
Corner St. 92, Trapeang Svay, Khan Sensok, Phnom Penh
Thmey, Phnom Penh
Phone: 85512715666
Country 52766 0
Cambodia
Phone 52766 0
+855 12 715 666
Fax 52766 0
Email 52766 0
rithealeang@gmail.com
Contact person for public queries
Name 52767 0
Denis Mey Bouth
Address 52767 0
National Centre for Parasitology, Entomology and Malaria Control Program
Corner St. 92, Trapeang Svay, Khan Sensok, Phnom Penh Thmey, Phnom Penh
Country 52767 0
Cambodia
Phone 52767 0
(+855 )12 858 320
Fax 52767 0
(+855) 23 996 202
Email 52767 0
mbdenis@yahoo.com
Contact person for scientific queries
Name 52768 0
Heng Pisal
Address 52768 0
National Centre for Parasitology, Entomology and Malaria Control Program
Corner St. 92, Trapeang Svay, Khan Sensok, Phnom Penh Thmey, Phnom Penh
Country 52768 0
Cambodia
Phone 52768 0
(+855) 23 996 202
Fax 52768 0
Email 52768 0
hengpisal16@gmail.com

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.