Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001628134
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring and evaluation of efficacy and safety of Artesunate-Amodiaquine (ASAQ) in Ta Sanh Health Centre (Battambong) and Kvav Health Centre (Siem Reap) with a single 15-mg adult dose of Primaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia
Scientific title
Clinical and parasitological efficacy of artesunate-amodiaquine over 28 days in the treatment of uncomplicated falciparum malaria in Cambodia
Secondary ID [1] 299113 0
136NECHR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with Plasmodium falciparum infection 314163 0
Condition category
Condition code
Infection 312533 312533 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 the efficacy and safety of Artesunate-Amodiaquine (ASAQ) for the treatment of Plasmodium falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet containing 135mg AQ and 50mg AS for the patients with 8-17 kg body weight over 3 days, 1 tablet containing 270mg AQ and 100mg AS for the patients with 17-35 kg body weight and 2 tablets for the patients above 35 kg body weight over 3 days. A single oral dose of 15-mg adult dose of Primaquine was given to the patient on the first day of treatment. The blood slide was daily examined until the patients it was negative on 2 consecutive days. The patients took each dose of the drug in front of the health staff, and they stayed at the study site for the first 3 or 4 days, and they returned to the study site weekly over 28 days.
Intervention code [1] 315380 0
Treatment: Drugs
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321175 0
The proportion of treatment successful which was confirmed by the polymerase chain reaction (PCR) based on the fresh blood.
Timepoint [1] 321175 0
Post-treatment at day 28
Secondary outcome [1] 374200 0
the proportions of the drug-induced adverse events such as vomiting, insomnia, and abdominal pain based on clinical examination, direct observation and participant self-reported
Timepoint [1] 374200 0
During the treatment at day 0, 1, and 2 and post-treatment at day 3

Eligibility
Key inclusion criteria
- Patients with the bodyweight of 8 kg or above
- P. falciparum infection
- Ability to swallow the drug
- Ability and willingness to comply with the study protocol
Minimum age
5 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy or lactation
- Severe malaria
- Mixed malaria infection

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Kaplan-Meier survival analysis
Cox proportional hazards

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/09/2016
Date of last participant enrolment
Anticipated
Actual
22/02/2017
Date of last data collection
Anticipated
Actual
26/03/2017
Sample size
Target
120
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 21807 0
Cambodia
State/province [1] 21807 0
Pursat and Mondulkiri

Funding & Sponsors
Funding source category [1] 303651 0
Other
Name [1] 303651 0
World Health Organization
Country [1] 303651 0
Switzerland
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] 303739 0
Government body
Name [1] 303739 0
National Center for Malaria Control, Parasitology and Entomology
Address [1] 303739 0
National Center for Parasitology, Entomology and Malaria Control
#477 Betong (Corner st. 92), Trapeng Svay village, Sangkat Phnom Penh Thmey, Khan Sen Sok
Phnom Penh
Country [1] 303739 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304173 0
National Ethics Committee for Health Research at the Ministry of Health
Ethics committee address [1] 304173 0
Ethics committee country [1] 304173 0
Cambodia
Date submitted for ethics approval [1] 304173 0
04/03/2016
Approval date [1] 304173 0
29/03/2016
Ethics approval number [1] 304173 0
136NECHR

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

Contacts
Principal investigator
Name 96046 0
Dr Rithea Leang
Address 96046 0
National Center for Parasitology, Entomology and Malaria Control
477 Betong St, Corner St. 92, Trapeng Svay village, Sangkat Phnom Penh Thmey, Phnom Penh
Country 96046 0
Cambodia
Phone 96046 0
+85512715666
Fax 96046 0
Email 96046 0
[email protected]
Contact person for public queries
Name 96047 0
Mey Bouth Denis
Address 96047 0
National Center for Parasitology, Entomology and Malaria Control
477 Betong St, Corner St. 92, Trapeng Svay village, Sangkat Phnom Penh Thmey, Phnom Penh
Country 96047 0
Cambodia
Phone 96047 0
+85512858320
Fax 96047 0
Email 96047 0
[email protected]
Contact person for scientific queries
Name 96048 0
Ringwald Pascal
Address 96048 0
World Health Organization
20 Av. Appia, 1211 Geneva 27
Country 96048 0
Switzerland
Phone 96048 0
+41227913469
Fax 96048 0
+41227914824
Email 96048 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4286Ethical approval    378247-(Uploaded-24-08-2019-14-49-13)-Study-related document.pdf



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.