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Trial registered on ANZCTR


Registration number
ACTRN12618001300268
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
2/08/2018
Date last updated
2/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring and evaluation of efficacy and safety of Pyronaridine-Artesunate for the treatment with a low single dose of Primaquine of uncomplicated Plasmodium falciparum malaria in Cambodia
Scientific title
Clinical and parasitological efficacy over 42 days of artesunate-pyronaridine in the treatment of uncomplicated falciparum malaria in 2 provinces in Cambodia
Secondary ID [1] 295586 0
086NECHR
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Patients with plasmodium falciparum infection 308886 0
Condition category
Condition code
Infection 307796 307796 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is a single arm open-label study to evaluate therapeutic efficacy and safety of Pyronaridine-Artesunate for the treatment of Plasmodium falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet for the patients 20-<24 kg body weight, 2 tablets for 24-<45 kg body weight, 3 tablets for 45-<65 kg body weight and 4 tablets for the patients over 65 kg over 3 days. One tablet contains 60mg artesunate plus 18 mg pyronaridine. The patients took the drugs in front of the field-based medical doctor. A full dose was repeated if a patient vomited within 30 minutes following the drug administration. The patients had a blood smear examined by microscope on a daily basis until they were negative on 2 consecutive days. The patients were to visit the study site once a week over 42 days. The patient's home visit was conducted when any patient did not come as the appointment schedule.
Intervention code [1] 301887 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306781 0
The proportion of adequate clinical and parasitological response (no malaria clinical sings and symptom and no malaria parasites detected) confirmed by the polymerase chain reaction (PCR) in which filter papers collected 2 to 3 drops of blood on the admission day and the day of recurrent infection were paired for parasite DNA extraction and genotype.
Timepoint [1] 306781 0
42 Days
Secondary outcome [1] 349646 0
The proportions of drug-induced adverse events such as nausea or vomiting clinically observed within 72 hours following the drug administration by the medical doctor.
Timepoint [1] 349646 0
at day 0, 1, 2, 3

Eligibility
Key inclusion criteria
- Adults and children with the body weight of 20 kg or above
- Mono-infection with P. falciparum
- History of fever within 24 hours or presence of axillary (under the armpit) above 37.5 °C
- Ability to swallow medication
- Ability and willingness to comply with the study protocol during the study period
Minimum age
15 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of non-malaria febrile conditions
- Pregnancy or lactation
- Severe malaria

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
Type of endpoint(s)
Statistical methods / analysis
Kaplan-Meier survival analysis
Cox proportional hazards regression

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] 10664 0
Cambodia
State/province [1] 10664 0
Provinces of Mondulkiri and Rattanakiri

Funding & Sponsors
Funding source category [1] 300164 0
Other
Name [1] 300164 0
World Health Organization
Address [1] 300164 0
1217 1st Floor, No. 61-64, Preah Norodom Blvd (St 306), Sangkat Boeung Keng Kang I, Khan Chamkamom Phnom Penh, Cambodia
Country [1] 300164 0
United States of America
Primary sponsor type
Government body
Name
Ministry of Health
Address
#80, 289 Samdach Penn Nouth St. (289), Phnom Penh, Cambodia
Country
Cambodia
Secondary sponsor category [1] 299572 0
Government body
Name [1] 299572 0
National Center for Parapsychology, Entomology and Malaria Control
Address [1] 299572 0
#477 Betong Street. ( Corner St.92), Village Trapangsvay, Sangkat Phnom Penh Thmey, Khan Sen Sok, Phnom Penh. Phone.
Country [1] 299572 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300997 0
National Ethics Committee for Health Research at Ministry of Health
Ethics committee address [1] 300997 0
Health, #80, 289 Samdach Penn Nouth St. (289), Phnom Penh, Cambodia
Ethics committee country [1] 300997 0
Cambodia
Date submitted for ethics approval [1] 300997 0
10/03/2017
Approval date [1] 300997 0
10/04/2017
Ethics approval number [1] 300997 0
086NECHR

Summary
Brief summary
This therapeutic efficacy study was to assess the efficacy and safety of the treatment of P. falciparum malaria with pyronaridine-artesunate
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 85546 0
Dr Rithea Leang
Address 85546 0
#477 Betong Street.( Corner St.92), Village Trapangsvay, Sangkat Phnom Penh Thmei, Phnom Penh
Country 85546 0
Cambodia
Phone 85546 0
85512715666
Fax 85546 0
Email 85546 0
rithealeang@gmail.com
Contact person for public queries
Name 85547 0
Dr Chea Huch
Address 85547 0
#477 Betong Street.( Corner St.92), Village Trapangsvay, Sangkat Phnom Penh Thmei, Phnom Penh
Country 85547 0
Cambodia
Phone 85547 0
85512308405
Fax 85547 0
Email 85547 0
huch.cnm@gmail.cin
Contact person for scientific queries
Name 85548 0
Dr Ringwald Pascal
Address 85548 0
World Health Organisation, 20 Av. Appia, 1211 Geneva 27
Country 85548 0
Switzerland
Phone 85548 0
41227913469
Fax 85548 0
41227914824
Email 85548 0
ringwaldp@who.int

No data has been provided for results reporting
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