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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
Scientific title
Clinical and parasitological efficacy over 42 days of Artesunate-Mefloquine in the treatment of uncomplicated Plasmodium falciparum in 3 provinces in Cambodia
Secondary ID [1] 295602 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Patients with P. falciparum infection 308924 0
Condition category
Condition code
Infection 307827 307827 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 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.
Intervention code [1] 301902 0
Treatment: Drugs
Comparator / control treatment
Ni
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306804 0
Proportions of treatment successful confirmed by the Polymerase Chain-Reaction (PCR)
Timepoint [1] 306804 0
42 days post-enrolment
Secondary outcome [1] 349699 0
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.
Timepoint [1] 349699 0
Day 0, 1, 2, 3

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
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
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] 10670 0
Cambodia
State/province [1] 10670 0
Provinces of Pursat, Kampong Speu and Stung Treng

Funding & Sponsors
Funding source category [1] 300177 0
Other
Name [1] 300177 0
World Health Organization
Address [1] 300177 0
1217 1st Floor, No. 61-64, Preah Norodom Blvd (St 306), Sangkat Beong Keng Kang I, Khan Chamkamon, Phnom Penh
Country [1] 300177 0
United States of America
Primary sponsor type
Government body
Name
Ministry of Health
Address
#80, 289 Samdach Penn Nouth St (289), Phnom Penh
Country
Cambodia
Secondary sponsor category [1] 299588 0
Government body
Name [1] 299588 0
National Center for Parasitology, Entomology and Malaria Control
Address [1] 299588 0
#477 Betong Street, (Corner St. 92), Village Trapengsvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phnom Penh.
Country [1] 299588 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301009 0
National Ethics Committee for Health Research at Ministry of Health
Ethics committee address [1] 301009 0
#80, 289 Samdach Penn Nouth St. (289), Phnom Penh
Ethics committee country [1] 301009 0
Cambodia
Date submitted for ethics approval [1] 301009 0
10/03/2017
Approval date [1] 301009 0
10/04/2017
Ethics approval number [1] 301009 0
087NECHR

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

Contacts
Principal investigator
Name 85586 0
Dr Rithea Leang
Address 85586 0
#477 Betong Street. (Corner St.92), Village Trapgensvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phom Penh.
Country 85586 0
Cambodia
Phone 85586 0
85512715666
Fax 85586 0
Email 85586 0
rithealeang@gmail.com
Contact person for public queries
Name 85587 0
Dr Chea Huch
Address 85587 0
#477 Betong Street. (Corner St.92), Village Trapgensvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phom Penh.
Country 85587 0
Cambodia
Phone 85587 0
85512308405
Fax 85587 0
Email 85587 0
huch.cnm@gmail.cin
Contact person for scientific queries
Name 85588 0
Dr Ringwald Pascal
Address 85588 0
World Health Organization, 20 Av, Appia, 12211 Geneva 27
Country 85588 0
Swaziland
Phone 85588 0
41227913469
Fax 85588 0
41227914824
Email 85588 0
ringwaldp@who.int

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