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
Date results information 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
Ministry of Health
#80, 289 Samdach Penn Nouth St (289), Phnom Penh
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
This therapeutic efficacy study was to assess the efficacy of ASAQ for the treatment of P. malaria over 28 days. The result was useful for the policymakers to modify the current national treatment guideline for P. malaria infection in Cambodia
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
Prof 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
Dr 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.