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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
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Scientific title
Clinical and parasitological efficacy over 42 days of artesunate-pyronaridine in the treatment of uncomplicated falciparum malaria in 2 provinces in Cambodia
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Secondary ID [1]
295586
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086NECHR
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
Nil
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Health condition
Health condition(s) or problem(s) studied:
Patients with plasmodium falciparum infection
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Condition category
Condition code
Infection
307796
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
301887
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Treatment: Drugs
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
306781
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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.
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Assessment method [1]
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Timepoint [1]
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42 Days
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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at day 0, 1, 2, 3
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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
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Minimum age
15
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 non-malaria febrile conditions
- Pregnancy or lactation
- Severe malaria
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
Kaplan-Meier survival analysis
Cox proportional hazards regression
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
17/10/2017
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Date of last participant enrolment
Anticipated
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Actual
21/02/2018
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Date of last data collection
Anticipated
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Actual
5/04/2018
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Sample size
Target
120
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Accrual to date
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Final
111
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Recruitment outside Australia
Country [1]
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Cambodia
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State/province [1]
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Provinces of Mondulkiri and Rattanakiri
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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World Health Organization
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Address [1]
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1217 1st Floor, No. 61-64, Preah Norodom Blvd (St 306), Sangkat Boeung Keng Kang I, Khan Chamkamom Phnom Penh, Cambodia
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Country [1]
300164
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United States of America
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Primary sponsor type
Government body
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Name
Ministry of Health
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Address
#80, 289 Samdach Penn Nouth St. (289), Phnom Penh, Cambodia
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Country
Cambodia
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Secondary sponsor category [1]
299572
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Government body
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Name [1]
299572
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National Center for Parapsychology, Entomology and Malaria Control
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Address [1]
299572
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#477 Betong Street. ( Corner St.92), Village Trapangsvay, Sangkat Phnom Penh Thmey, Khan Sen Sok, Phnom Penh. Phone.
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Country [1]
299572
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Cambodia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300997
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National Ethics Committee for Health Research at Ministry of Health
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Ethics committee address [1]
300997
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Health, #80, 289 Samdach Penn Nouth St. (289), Phnom Penh, Cambodia
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Ethics committee country [1]
300997
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Cambodia
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Date submitted for ethics approval [1]
300997
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10/03/2017
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Approval date [1]
300997
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10/04/2017
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Ethics approval number [1]
300997
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086NECHR
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Summary
Brief summary
This therapeutic efficacy study was to assess the efficacy and safety of the treatment of P. falciparum malaria with pyronaridine-artesunate
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Trial website
Nil
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Trial related presentations / publications
Nil
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Public notes
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Contacts
Principal investigator
Name
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Dr Rithea Leang
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Address
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#477 Betong Street.( Corner St.92), Village Trapangsvay, Sangkat Phnom Penh Thmei, Phnom Penh
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Country
85546
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Cambodia
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Phone
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85512715666
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Fax
85546
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Email
85546
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[email protected]
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Contact person for public queries
Name
85547
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Dr Chea Huch
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Address
85547
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#477 Betong Street.( Corner St.92), Village Trapangsvay, Sangkat Phnom Penh Thmei, Phnom Penh
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Country
85547
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Cambodia
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Phone
85547
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85512308405
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Fax
85547
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Email
85547
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[email protected]
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Contact person for scientific queries
Name
85548
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Dr Ringwald Pascal
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Address
85548
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World Health Organisation, 20 Av. Appia, 1211 Geneva 27
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Country
85548
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Switzerland
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Phone
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41227913469
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Fax
85548
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41227914824
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Email
85548
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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
Source
Title
Year of Publication
DOI
Embase
Efficacy and safety of pyronaridine-artesunate plus single-dose primaquine for treatment of uncomplicated plasmodium falciparum malaria in eastern Cambodia.
2019
https://dx.doi.org/10.1128/AAC.02242-18
N.B. These documents automatically identified may not have been verified by the study sponsor.
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