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Trial registered on ANZCTR


Registration number
ACTRN12609000816257
Ethics application status
Approved
Date submitted
25/05/2009
Date registered
18/09/2009
Date last updated
18/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study: Comparison of the efficacy of artemisinin plus piperaquine (Artequick), artesunate plus amodiaquine (Coarsucam) and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in Vietnam
Scientific title
Pilot Study: Comparison of the efficacy of artemisinin plus piperaquine (Artequick), artesunate plus amodiaquine (Coarsucam) and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in Vietnam
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria infection 4852 0
Condition category
Condition code
Infection 237200 237200 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Malaria patients will be administered either Artequick (2.5 mg/kg artemisinin and 15 mg/kg piperaquine daily) for 2 days, Coarsucam (4 mg/kg artesunate plus 10 mg/kg amodiaquine daily) for 3 days or 4 mg/kg artesunate plus 30 mg/kg azithromycin daily for 3 days. The mode of administration is oral dosing.
Intervention code [1] 236635 0
Treatment: Drugs
Comparator / control treatment
Clinical efficacy and tolerability will be compared between the three treatment groups
Control group
Active

Outcomes
Primary outcome [1] 238012 0
To compare the therapeutic efficacy and tolerability of three artemisinin-based combination therapies (ACTs); artemisinin plus piperaquine (Artequick), artesunate plus amodiaquine (Coarsucam) and artesunate plus azithromycin for the treatment of uncomplicated Plasmodium falciparum in an area of central Vietnam. The efficacy of the three ACTs are compared by the number of patients cured of their infection over a 42-day follow-up period. Recrudescences of infection will be determined by Polymerase Chain Reaction (PCR) analysis.
Timepoint [1] 238012 0
Parasitaemia clearance will be determined from blood smears collected 12 hourly after starting treatment by microscopic analysis until negative and at weeks 1, 2, 3, 4, 5, and 6 after commencement of treatment. Blood spots for PCR analysis will also be collected before treatment and at weeks 1, 2, 3, 4, 5, and 6 after starting treatment.
Secondary outcome [1] 242156 0
To determine the in vitro susceptibility and molecular genotyping of Plasmodium falciparum isolates collected from malaria patients at Phuoc Chien Commune, central Vietnam. In vitro drug susceptibility testing will be carried out on a blood samples collected from the patients before starting treatment using the field microtechnique candle-jar method and molecular genotyping of Plasmodium falciparum isolates will be carried out using Multiplex PCR-Restriction Fragment Length Polymorphism (RFLP) analysis.
Timepoint [1] 242156 0
In vitro minimum inhibitory concentration (MIC) of several antimalarial drugs, Plasmodium falciparum chloroquine resistant transporter gene (Pfcrt) and Plasmodium falciparum multidrug-resistant 1 gene (Pfmdr1) will be assessed on a blood sample collected before starting treatment.

Eligibility
Key inclusion criteria
(i) Sex: male or female
(ii) Age: Between 5 years and 65 years old
(iii) Falciparum malaria with parasitaemia between 200 and 200,000 parasites/uL of blood
(iv) Is willing to give small amounts of blood via finger prick and phlebotomy
(vi) Written informed consent and agreed to treatment follow-up for a total of 42 days
Minimum age
5 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Severe/cerebral malaria or history of another serious medical disease
(ii) Prior treatment with an artemisinin drug within the previous 7 days
(iii) Pregnancy and lactating
(iv) Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of drugs was not concealed. Patients were sequentially allocated to the three treatment groups: Artequick for 2 days, Coarsucam for 3 days or artesunate-azithromycin for 3 days, with the first patient receiving Artequick, the second patient Coarsucam, the third patient artesunate-azithromycin, and so on.
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
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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] 1805 0
Viet Nam
State/province [1] 1805 0

Funding & Sponsors
Funding source category [1] 5018 0
Government body
Name [1] 5018 0
Australian Department of Defence
Address [1] 5018 0
International Policy Division
Russell Offices
R1-5-C015
Russell Drive
Canberra
ACT 2600
Country [1] 5018 0
Australia
Primary sponsor type
Other
Name
Australian Army Malaria Institute
Address
Weary Dunlop Drive
Gallipoli Barracks
Enoggera Brisbane
QLD 4051
Country
Australia
Secondary sponsor category [1] 4535 0
Government body
Name [1] 4535 0
Vietnam People's Army
Address [1] 4535 0
Military Institute of Hygiene and Epidemiology
21-Trung Liet
Dong Da, Hanoi
Country [1] 4535 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7115 0
Australian Defence Human Research Ethics Committee
Ethics committee address [1] 7115 0
Campbell Park
Campbell ACT 2612
Ethics committee country [1] 7115 0
Australia
Date submitted for ethics approval [1] 7115 0
Approval date [1] 7115 0
03/05/2008
Ethics approval number [1] 7115 0
ADHREC 507/08

Summary
Brief summary
Over 80 countries worldwide use artemisinin-based combination therapy (ACT) as first-line treatment of Plasmodium falciparum malaria. Debate continues as to the most effective ACT and how they will be deployed. Which ACT is the best combination therapy for first-line treatment in Vietnam has not been adequately studied. In the present study, we propose to investigate the efficacy and tolerability of three ACTs (artemisinin plus piperaquine, artesunate plus amodiaquine and artesunate plus azithromycin) in central Vietnam.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29645 0
Address 29645 0
Country 29645 0
Phone 29645 0
Fax 29645 0
Email 29645 0
Contact person for public queries
Name 12892 0
Dr Mike Edstein
Address 12892 0
Australian Army Malaria Institute
Weary Dunlop Drive
Gallipoli Barracks
Enoggera Brisbane
QLD 4051
Country 12892 0
Australia
Phone 12892 0
61-7-33324930
Fax 12892 0
61-7-33324800
Email 12892 0
Mike.Edstein@defence.gov.au
Contact person for scientific queries
Name 3820 0
Dr Mike Edstein
Address 3820 0
Australian Army Malaria Institute
Weary Dunlop Drive
Gallipoli Barracks
Enoggera Brisbane
QLD 4051
Country 3820 0
Australia
Phone 3820 0
61-7-33324930
Fax 3820 0
61-7-33324800
Email 3820 0
Mike.Edstein@defence.gov.au

No information has been provided regarding IPD availability
Summary results
No Results