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Trial registered on ANZCTR


Registration number
ACTRN12618001999224
Ethics application status
Approved
Date submitted
28/11/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia
Scientific title
Clinical and parasitological efficacy over 42 days of Artesunate-Mefloquine and Artesunate-Pyronaridine in the treatment of uncomplicated Plasmodium falciparum and vivax malaria in 5 provinces in Cambodia
Secondary ID [1] 296724 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 310586 0
Patients with P. vivax 310587 0
Condition category
Condition code
Infection 309299 309299 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 Artesunate-Mefloquine (ASMQ) for the treatment of P. falciparum and P. vivax malaria in Mondulkiri, Rattanakiri and Kratie provinces, and Artesunate-Pyronaridine (ASPY) in Pursat and Kampong Speu provinces. For the ASMQ treatment group, a patient with P. falciparum or P. vivax infection was given a daily dose of 1 tablet for 18-29kg, and 2 tablets for 30 kg body weight or above over 3 days. One tablet of ASMQ contains 100mg Artesunate plus 220mg Mefloquine. Only adults or children with at least 20 kg body weight were treated for the ASPY treatment group. A patient with P. falciparum or P. vivax was given a daily dose of 1 tablet for 20-<24 kg body weight, 2 tablets for 24-<45, 3 tablets for 45-<65 kg body weight, and 4 tablets for 65 kg body weight or above. One table of ASPY contains 60mg Artesunate and 180mg Pyronaridine. A patient is given a full dose if he/she vomits within 30 minutes following the drug administration. A blood smear was examined by microscope every 24 hours until the patient becomes negative over 2 consecutive days. The physical and parasitological examinations are conducted on weekly basis over 28 days for P. vivax patients and 42 days for P. falciparum patients.


Intervention code [1] 313030 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308266 0
Proportions of treatment successful confirmed by Polymerase Chain-Reaction (PCR). Three drops of blood will be collected on a filter paper (3M Whatman filter) at day 0 and day of failure to define putative markers related to antimalarial drugs resistance.
Timepoint [1] 308266 0
28 days post-enrolment for patients with P. vivax malaria and 42 days post-enrolment for patients with P. falciparum malaria
Secondary outcome [1] 354476 0
Proportions of malaria prevalence, drug-induced adverse events such as nausea, vomiting, and dizziness as well as the proportions of other clinical sign and symptoms resulted from the physical examination such as fever, abdominal pain, dark urine, and tachycardia.
Timepoint [1] 354476 0
Day 0, 1, 2,3

Eligibility
Key inclusion criteria
Mono-infection with P. falciparum or P. vivax
Axillary above 37.5 Celsius or fever history over the last 24 hours
Ability to swallow oral medication
Ability and willingness to comply with the study for the duration of the study
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-malaria febrile
Pregnancy or lactation
Mixed infection or 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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/09/2018
Date of last participant enrolment
Anticipated
4/02/2019
Actual
Date of last data collection
Anticipated
18/03/2019
Actual
Sample size
Target
600
Accrual to date
425
Final
Recruitment outside Australia
Country [1] 21086 0
Cambodia
State/province [1] 21086 0
Provinces of Pursast, Kampong Speu, Mondulkiri, Rattanakiri, and Kratie

Funding & Sponsors
Funding source category [1] 301303 0
Other
Name [1] 301303 0
World Health Organization
Country [1] 301303 0
Cambodia
Funding source category [2] 301305 0
Other
Name [2] 301305 0
U.S. Agency for International Development
Country [2] 301305 0
Cambodia
Primary sponsor type
Government body
Name
National Center for Parasitology, Entomology, and Malaria Control
Address
#477 Betong Street, (Corner St.92), Village Trapengsvay, Sangkat Phnom Penh Thmey, Khan Sensok, Phnom Penh
Country
Cambodia
Secondary sponsor category [1] 300958 0
Government body
Name [1] 300958 0
Ministry of Health
Address [1] 300958 0
#80, 289 Samdach Penn Nouth St.(289), Phnom Penh
Country [1] 300958 0
Cambodia
Secondary sponsor category [2] 300959 0
Government body
Name [2] 300959 0
Institute Pasteur of Cambodia
Address [2] 300959 0
No. 5, Monivong Boulevard, 12201 Phnom Penh
Country [2] 300959 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302046 0
National Ethics Committee for Health Research
Ethics committee address [1] 302046 0
Ethics committee country [1] 302046 0
Cambodia
Date submitted for ethics approval [1] 302046 0
02/04/2018
Approval date [1] 302046 0
04/05/2018
Ethics approval number [1] 302046 0
106NECHR

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88946 0
Dr RITHEA Leang
Address 88946 0
National Center for Parasitology, Entomology, and Malaria Control
Health Research Unit
#477 Betong St (Corner St. 92), Trapeng Svay Village, Sangkat Phnom Penh Thmey, Khan Sensok, Phnom Penh
Country 88946 0
Cambodia
Phone 88946 0
85512715666
Fax 88946 0
Email 88946 0
rithealeang@gmail.com
Contact person for public queries
Name 88947 0
Denis Mey Bouth
Address 88947 0
National Center for Parasitology, Entomology, and Malaria Control
#477 Betong St (Corner St. 92), Trapeng Svay Village, Sangkat Phnom Penh Thmey, Khan Sensok, Phnom Penh
Country 88947 0
Cambodia
Phone 88947 0
85512858320
Fax 88947 0
Email 88947 0
meybouthd@gmail.com
Contact person for scientific queries
Name 88948 0
Ringwald Pascal
Address 88948 0
World Health Organization
Head Quarter, Geneva, Switzerland
Country 88948 0
Switzerland
Phone 88948 0
+41227913469
Fax 88948 0
Email 88948 0
ringwaldp@who.int

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The results of treatment efficacy and the safety of study drugs.
When will data be available (start and end dates)?
From 15 to 30 April 2019
Available to whom?
Donors, MoH, WHO, and Director of the National Center for Parasitology, Entomology and Malaria Control
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Only with the approval of the Director of National Center for Parasitology, Entomology and Malaria Control with the agreement from WHO.


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
SourceTitleYear of PublicationDOI
EmbaseEfficacy and Safety of Pyronaridine-Artesunate plus Single-Dose Primaquine for the Treatment of Malaria in Western Cambodia.2019https://dx.doi.org/10.1128/AAC.01273-19
N.B. These documents automatically identified may not have been verified by the study sponsor.