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Trial registered on ANZCTR
Registration number
ACTRN12610000546055
Ethics application status
Approved
Date submitted
6/07/2010
Date registered
7/07/2010
Date last updated
7/07/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
A pilot study comparing the efficacy of artesunate alone and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in central Vietnam
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Scientific title
A pilot study comparing the efficacy and tolerability of artesunate alone and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in central Vietnam
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Secondary ID [1]
252164
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malaria infection
257707
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Condition category
Condition code
Infection
257877
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Malaria patients will be given either artesunate alone (4 mg/kg on the first day of treatment then 2 mg/kg daily for 6 days) or artesunate (4 mg/kg) plus azithromycin (20 mg/kg) daily for 3 days for the treatment of uncomplicated falciparum malaria. The mode of administration will be by the oral route.
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Intervention code [1]
256761
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Treatment: Drugs
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Comparator / control treatment
Clinical efficacy and tolerability will be compared between the two treatment groups.
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare the therapeutic efficacy of artesunate alone and artesunate plus azithromycin for the treatment of uncomplicated Plasmodium falciparum in central Vietnam. Also, by evaluating artesunate alone will provide efficacy data as to whether there is reduced susceptibility to the artemisinin at the study site.
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Assessment method [1]
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Timepoint [1]
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Parasitaemia clearance will be determined from blood smears collected 12 hourly after starting treatment until three consecutive smears are negative for parasites. For the artesunate alone group follow-up blood smears will be taken at days 7, 14, 21, and 28 and for the artesunate plus azithromycin group at days 7, 14, 21, 28, 35 and 42 after starting treatment . Blood spots on filter paper will also be obtained at enrolment and on days 7 onwards at the same time blood smears are collected for the two treatment groups. A blood smear and filter blood spot will also be obtained for any patient that has a recurrence of malaria infection during the follow-up periods.
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Primary outcome [2]
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To compare the tolerability of artesunate alone and artesunate plus azithromycin for the treatment of uncomplicated Plasmodium falciparum in central Vietnam.
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Assessment method [2]
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Timepoint [2]
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Adverse events (eg., nausea, headache, fever, abdominal pain, vomiting and anorexia) will be recorded before commencement of treatment and at 24 h intervals after starting treatment until adverse events have disappeared.
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Secondary outcome [1]
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Multiplex Polymerase Chain Reaction (PCR) analysis will be done to distinguish recrudences from reinfections by targeting the genes, msp1, msp2 and glurp. Molecular genotyping of patient's Plasmodium falciparum parasites will be carried out using Multiplex PCR-Restriction Fragment Length Polymporphism (RFLP) analysis on the collected filter blood spots to characterise the frequency of Plasmodium falciparum chloroquine resistant transporter and multidrug-resistant genes.
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Assessment method [1]
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Timepoint [1]
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Multiplex PCR analysis will be done on patients who present with a recurrence of malaria during the 28 days follow-up period for patients on artesunate alone and 42 days for patients on artesunate plus azithromycin. Molecular genotyping of patient's Plasmodium falciparum parasites will be carried out using RFLP analysis on the collected filter blood spots before starting treatment.
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Eligibility
Key inclusion criteria
(i) Patients with falciparum malaria with parasitaemia between 100 and 200,000 parasites/uL of blood
(ii) Is willing to give small amounts of blood via finger prick and phlebotomy
(iii) Written informed consent and agreed to treatment follow-up for a total of 28 days for artesunate alone and 42 days for artesunate plus azithromycin.
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Minimum age
5
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of drugs will not be concealed. Patients will be sequentially allocated to the two treatment groups: Artesunate alone for 7 days and artesunate plus azithromycin for 3 days, with the first patient to receive artesunate alone , the second patient artesunate plus azithromycin, the third patient artesunate alone , and so on.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
17/05/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2746
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Viet Nam
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State/province [1]
2746
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Department of Defence
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Address [1]
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International Policy Division Russell Offices R1-5-C015 Russell Drive Canberra ACT 2600
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Australian Army Malaria Institute
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Address
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane QLD 4051
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Vietnam People's Army
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Address [1]
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Military Institute of Hygiene and Epidemiology, 21-Trung Liet Dong Da, Hanoi
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Country [1]
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Viet Nam
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
259272
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Australian Defence Human Research Ethics Committee
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Ethics committee address [1]
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Campbell Park, Campbell, Canberra, ACT 2612
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Ethics committee country [1]
259272
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Australia
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Date submitted for ethics approval [1]
259272
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Approval date [1]
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30/04/2010
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Ethics approval number [1]
259272
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ADHREC 586-10
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Summary
Brief summary
Artemisinin-based combination treatments (ACT) are now recommended as first-line treatment for Plasmodium falciparum malaria worldwide. Recent studies have shown reduce susceptibility of artesunate in western Cambodia and thus there is an urgent need to know whether artesunate resistance is present in neighbouring Southeast Asian countries such as Vietnam. In this study, we propose to assess whether reduce susceptibility exists at a commune in central Vietnam by giving patients a 7 day course of artesunate alone. At the same time, we will evaluate the efficacy of the ACT, artesunate plus azithromycin as this combination is meant to be safe in special risk groups such as young children and during pregnancy. However, before testing the artesunate plus azithromycin in special risk groups we need to know that the ACT is efficacious in the general population between 5 and 65 years.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Mike Edstein
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Address
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Australian Army Malaria Institute
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane QLD 4051
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Country
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Australia
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Phone
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61-7-33324930
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Fax
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61-7-33324800
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Mike Edstein
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Address
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Australian Army Malaria Institute
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane QLD 4051
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Country
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Australia
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Phone
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61-7-33324930
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Fax
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61-7-33324800
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
In vivo efficacy and tolerability of artesunate-azithromycin for the treatment of falciparum malaria in Vietnam.
2016
https://dx.doi.org/10.4269/ajtmh.16-0144
N.B. These documents automatically identified may not have been verified by the study sponsor.
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