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Trial registered on ANZCTR


Registration number
ACTRN12605000596606
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
5/10/2005
Date last updated
5/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
SAFETY AND EFFICACY OF AMBISOME VS CONVENTIONAL AMPHOTERICIN B IN THE TREATMENT OF PATIENTS WITH SUSPECTED OR CONFIRMED MYCOSIS
Scientific title
SAFETY AND EFFICACY OF AMBISOME VS CONVENTIONAL AMPHOTERICIN B IN THE TREATMENT OF PATIENTS WITH SUSPECTED OR CONFIRMED MYCOSIS
Secondary ID [1] 187 0
104-CM-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mycosis - an invasive fungal infections 725 0
Condition category
Condition code
Infection 802 802 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Systemic treatment of mycosis with either liposomal amphotericin B (AmBisome by Gilead Sciences) or conventional amphotericin B (Fungizone by Bristol-Myers Squibb). Treatment will be given for a minimum of 14 days. However, if the patient's condition deteriorates after 10 days of therapy, the patient will be switched to salvage therapy (AmBisome 5mg/kg/day). TOtal duration of therapy depends on the infection and the patient's condition.
Intervention code [1] 354 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1028 0
Primary endpoint is the rate of treatment related adverse events
Timepoint [1] 1028 0
Measured thoughout the study
Secondary outcome [1] 1919 0
Microbiological & Clinical Evaluation measured during double blind period and rescue period.
Timepoint [1] 1919 0

Eligibility
Key inclusion criteria
Highly suspected or confirmed invasive fungal infection.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 889 0
Commercial sector/Industry
Name [1] 889 0
Gilead Sciences Pty Ltd
Address [1] 889 0
Country [1] 889 0
Primary sponsor type
Individual
Name
Dr. Michael Whitby (Princess Alexandra Hsp, QLD)
Address
Country
Australia
Secondary sponsor category [1] 751 0
Commercial sector/Industry
Name [1] 751 0
Gilead Sciences Pty Ltd
Address [1] 751 0
Country [1] 751 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35375 0
Address 35375 0
Country 35375 0
Phone 35375 0
Fax 35375 0
Email 35375 0
Contact person for public queries
Name 9543 0
Dr. Michael Whitby
Address 9543 0
Infectious Diseases Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 9543 0
Australia
Phone 9543 0
+61 7 32402595
Fax 9543 0
Email 9543 0
m.whitby@mailbox.uq.edu.au
Contact person for scientific queries
Name 471 0
Dr. Michael Whitby
Address 471 0
Infectious Diseases Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 471 0
Australia
Phone 471 0
+61 7 32402595
Fax 471 0
Email 471 0
m.whitby@mailbox.uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary