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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
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
Secondary ID [1] 252164 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria infection 257707 0
Condition category
Condition code
Infection 257877 257877 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256761 0
Treatment: Drugs
Comparator / control treatment
Clinical efficacy and tolerability will be compared between the two treatment groups.
Control group
Active

Outcomes
Primary outcome [1] 258741 0
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.
Timepoint [1] 258741 0
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.
Primary outcome [2] 258745 0
To compare the tolerability of artesunate alone and artesunate plus azithromycin for the treatment of uncomplicated Plasmodium falciparum in central Vietnam.
Timepoint [2] 258745 0
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.
Secondary outcome [1] 264789 0
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.
Timepoint [1] 264789 0
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.

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.
Minimum age
5 Years
Maximum age
65 Years
Sex
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
Non-randomised trial
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.
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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2746 0
Viet Nam
State/province [1] 2746 0

Funding & Sponsors
Funding source category [1] 257254 0
Government body
Name [1] 257254 0
Australian Department of Defence
Country [1] 257254 0
Australia
Primary sponsor type
Government body
Name
Australian Army Malaria Institute
Address
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane QLD 4051
Country
Australia
Secondary sponsor category [1] 256497 0
Government body
Name [1] 256497 0
Vietnam People's Army
Address [1] 256497 0
Military Institute of Hygiene and Epidemiology, 21-Trung Liet Dong Da, Hanoi
Country [1] 256497 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259272 0
Australian Defence Human Research Ethics Committee
Ethics committee address [1] 259272 0
Campbell Park, Campbell, Canberra, ACT 2612
Ethics committee country [1] 259272 0
Australia
Date submitted for ethics approval [1] 259272 0
Approval date [1] 259272 0
30/04/2010
Ethics approval number [1] 259272 0
ADHREC 586-10

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31368 0
Address 31368 0
Country 31368 0
Phone 31368 0
Fax 31368 0
Email 31368 0
Contact person for public queries
Name 14615 0
Dr Mike Edstein
Address 14615 0
Australian Army Malaria Institute
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane QLD 4051
Country 14615 0
Australia
Phone 14615 0
61-7-33324930
Fax 14615 0
61-7-33324800
Email 14615 0
Mike.Edstein@defence.gov.au
Contact person for scientific queries
Name 5543 0
Dr Mike Edstein
Address 5543 0
Australian Army Malaria Institute
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane QLD 4051
Country 5543 0
Australia
Phone 5543 0
61-7-33324930
Fax 5543 0
61-7-33324800
Email 5543 0
Mike.Edstein@defence.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseIn vivo efficacy and tolerability of artesunate-azithromycin for the treatment of falciparum malaria in Vietnam.2016https://dx.doi.org/10.4269/ajtmh.16-0144
N.B. These documents automatically identified may not have been verified by the study sponsor.