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Trial registered on ANZCTR


Registration number
ACTRN12622000638730
Ethics application status
Approved
Date submitted
15/12/2021
Date registered
2/05/2022
Date last updated
2/05/2022
Date data sharing statement initially provided
2/05/2022
Date results information initially provided
2/05/2022
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 of artesunate-amodiaquine over 28 days in the treatment of uncomplicated falciparum malaria in Cambodia
Secondary ID [1] 306061 0
120NECHR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with Plasmodium falciparum infection 324703 0
Patients with Plasmodium vivax infection 325276 0
Condition category
Condition code
Infection 322154 322154 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ASMQ (Artesunate + Mefloquine co-formulated). The adult dose tablet contains 100mg Artesunate plus 220mg Mefloquine and the pediatric tablet contain 55mg Artesunate plus 55 mg Mefloquine. ASP (Artesunate + Pyronaridine/ Pyramax): Adults and children greater than or equal to 20 kg.
All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The patients are recommended to stay at the health facility until they complete the treatment course for malaria infection.
This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. Eligible patients were treated with a daily dose of 1 tablet containing 135mg amodiaquine 'AQ' and 50mg artesunate 'AS' for the patients with 8-17 kg body weight over 3 days, 1 tablet containing 270mg amodiaquine 'AQ' and 100mg artesunate 'AS' for the patients with 17-35 kg body weight and 2 tablets for the patients above 35 kg body weight over 3 days. In addition, 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 examined daily until the patient was negative on 2 consecutive days. The patients took each dose of the drug before the health stay, stayed at the study site for the first 3 or 4 days, and returned to the study site weekly over 28 days.
Intervention code [1] 322464 0
Treatment: Drugs
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330864 0
The proportion of patients with early treatment failure, late clinical failure, late parasitological failure, or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.
Timepoint [1] 330864 0
Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy.
Secondary outcome [1] 404297 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] 404297 0
During the treatment at days 0, 1, and 2 and post-treatment at day 3

Eligibility
Key inclusion criteria
The study population consisted of patients with uncomplicated P. falciparum or P. vivax malaria attending the study health clinic who are aged between 2-60 years for ASP and 18-60 years for ASMQ. All adult patients were above 18 years, age of majority in this country, signed an informed consent form for participation. Parents or guardians were informed consent on behalf of children who have not reached the age of majority. Children aged from 12 years and age of majority are required to consent for participation by signing an informed assent form.
Minimum age
2 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
Actual
31/10/2020
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
120
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 24449 0
Cambodia
State/province [1] 24449 0
Ratanakiri, Mondulkiri, Kampong Spue, Pursat

Funding & Sponsors
Funding source category [1] 310398 0
Other
Name [1] 310398 0
World Health Organization
Country [1] 310398 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] 311547 0
Government body
Name [1] 311547 0
National Center for Malaria Control, Parasitology and Entomology
Address [1] 311547 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] 311547 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310046 0
National Ethics Committee for Health Research at the Ministry of Health
Ethics committee address [1] 310046 0
Ministry of Health
#80, 289 Samdach Penn Nouth St (289), Phnom Penh
Ethics committee country [1] 310046 0
Cambodia
Date submitted for ethics approval [1] 310046 0
12/05/2020
Approval date [1] 310046 0
27/05/2020
Ethics approval number [1] 310046 0
120NECHR

Summary
Brief summary
This study was to monitor and evaluate 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116302 0
Dr Rithea Leang
Address 116302 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 116302 0
Cambodia
Phone 116302 0
+85512715666
Fax 116302 0
Email 116302 0
[email protected]
Contact person for public queries
Name 116303 0
Mey Bouth Denis
Address 116303 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 116303 0
Cambodia
Phone 116303 0
+85512858320
Fax 116303 0
Email 116303 0
[email protected]
Contact person for scientific queries
Name 116304 0
Ringwald Pascal
Address 116304 0
World Health Organization
20 Av. Appia, 1211 Geneva 27
Country 116304 0
Switzerland
Phone 116304 0
+41227913469
Fax 116304 0
+41227914824
Email 116304 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14450Ethical approval    383311-(Uploaded-15-12-2021-15-23-53)-Study-related document.pdf



Results publications and other study-related documents

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