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Trial registered on ANZCTR
Registration number
ACTRN12618001301257
Ethics application status
Approved
Date submitted
19/07/2018
Date registered
2/08/2018
Date last updated
2/08/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine with a low single dose of Primaquine for the treatment of uncomplicated Plasmodium malaria in Cambodia
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Scientific title
Clinical and parasitological efficacy over 42 days of Artesunate-Mefloquine in the treatment of uncomplicated Plasmodium falciparum in 3 provinces in Cambodia
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Secondary ID [1]
295602
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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
Nil
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Health condition
Health condition(s) or problem(s) studied:
Patients with P. falciparum infection
308924
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Condition category
Condition code
Infection
307827
307827
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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 therapeutically efficacy and safety of Artesunate-Mefloquine for the treatment of P. falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet for 18-29 kg, and 2 tablets for 30 kg body weight over 3 days. One tablet contains 100 mg Artesunate plus 220mg Mefloquine. The patients took the drugs in front of the field-based medical doctor and a complete dose was repeated if a patient vomited within 30 minutes following the drug administration. A blood smear was examined by the microscope on a daily basis until a patient became negative over 2 consecutive days. Then, the patients were asked to return to the study site once a week over 42 days. A home visit was made when any patient missed the appointment.
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Intervention code [1]
301902
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Treatment: Drugs
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Comparator / control treatment
Ni
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Proportions of treatment successful confirmed by the Polymerase Chain-Reaction (PCR)
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Assessment method [1]
306804
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Timepoint [1]
306804
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42 days post-enrolment
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Secondary outcome [1]
349699
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Proportions of drug-induced adverse events such as nausea, vomiting, dizziness. The patients were directly observed within 72 hours following the drug administration and were gone through clinical examination if necessary biological assessment. The patients were provided with appropriate treatment based on the results of the examination by the medical doctor.
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Assessment method [1]
349699
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Timepoint [1]
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Day 0, 1, 2, 3
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Eligibility
Key inclusion criteria
Mono-infection with P. falciparum
Axillary above 37.5 °C or history of fever over the past 24 hours.
Ability to swallow oral medication
Ability and willingness to comply with the study protocol for the duration of the study
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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
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
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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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
23/10/2017
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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
10/04/2018
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Sample size
Target
180
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Accrual to date
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Final
167
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Recruitment outside Australia
Country [1]
10670
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Cambodia
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State/province [1]
10670
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Provinces of Pursat, Kampong Speu and Stung Treng
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Funding & Sponsors
Funding source category [1]
300177
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Other
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Name [1]
300177
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World Health Organization
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Address [1]
300177
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1217 1st Floor, No. 61-64, Preah Norodom Blvd (St 306), Sangkat Beong Keng Kang I, Khan Chamkamon, Phnom Penh
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Country [1]
300177
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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
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Country
Cambodia
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Secondary sponsor category [1]
299588
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Government body
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Name [1]
299588
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National Center for Parasitology, Entomology and Malaria Control
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Address [1]
299588
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#477 Betong Street, (Corner St. 92), Village Trapengsvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phnom Penh.
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Country [1]
299588
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Cambodia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301009
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National Ethics Committee for Health Research at Ministry of Health
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Ethics committee address [1]
301009
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#80, 289 Samdach Penn Nouth St. (289), Phnom Penh
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Ethics committee country [1]
301009
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Cambodia
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Date submitted for ethics approval [1]
301009
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10/03/2017
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Approval date [1]
301009
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10/04/2017
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Ethics approval number [1]
301009
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087NECHR
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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 Artesunate-Mefloquine.
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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
85586
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Dr Rithea Leang
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Address
85586
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#477 Betong Street. (Corner St.92), Village Trapgensvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phom Penh.
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Country
85586
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Cambodia
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Phone
85586
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85512715666
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Fax
85586
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Email
85586
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[email protected]
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Contact person for public queries
Name
85587
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Dr Chea Huch
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Address
85587
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#477 Betong Street. (Corner St.92), Village Trapgensvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phom Penh.
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Country
85587
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Cambodia
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Phone
85587
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85512308405
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Fax
85587
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Email
85587
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[email protected]
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Contact person for scientific queries
Name
85588
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Dr Ringwald Pascal
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Address
85588
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World Health Organization, 20 Av, Appia, 12211 Geneva 27
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Country
85588
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Swaziland
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Phone
85588
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41227913469
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Fax
85588
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41227914824
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Email
85588
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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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