Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000324617
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
6/09/2005
Date last updated
19/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus (ATTAIN I & ATTAIN II)
Scientific title
A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus (ATTAIN I & ATTAIN II)
Secondary ID [1] 141 0
0015
Secondary ID [2] 142 0
0019
Universal Trial Number (UTN)
Trial acronym
ATTAIN I & ATTAIN II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital-Acquired Pneumonia 412 0
Condition category
Condition code
Respiratory 483 483 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telavancin 10 mg/kg q 24 hours IV
Intervention code [1] 333 0
Treatment: Drugs
Comparator / control treatment
Vancomycin 1 Gm q 12 hours IV
Control group
Active

Outcomes
Primary outcome [1] 554 0
Clinical response at test of cure evaluation
Timepoint [1] 554 0
Performed 7 to 14 days following completion of treatment
Secondary outcome [1] 1176 0
Safety and tolerability
Timepoint [1] 1176 0
Baseline, q 3d, End of Therapy and Test of Cure

Eligibility
Key inclusion criteria
Diagnosis of hospital acquired pneumonia.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
More than 24 hours of prior therapy unless a treatment failure. Pregnancy.

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)
Randomized treatment assigments are provided to the site pharmacist following enrollment of each patient using a centralized enrollment resource. The site pharmacist prepares the study treatments and they are labeled for administration in a blinded fashion per a site specific blinding plan.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SAS programming was utilized to generate a blocked, stratified random allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 159 0
United States of America
State/province [1] 159 0

Funding & Sponsors
Funding source category [1] 549 0
Commercial sector/Industry
Name [1] 549 0
Theravance, Inc
Country [1] 549 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Theravance, Inc.
Address
901 Gateway Blvd, South San Francisco, CA, USA
Country
United States of America
Secondary sponsor category [1] 443 0
None
Name [1] 443 0
none
Address [1] 443 0
Country [1] 443 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36274 0
Address 36274 0
Country 36274 0
Phone 36274 0
Fax 36274 0
Email 36274 0
Contact person for public queries
Name 9522 0
Denise Sharp
Address 9522 0
Theravance Inc.
901 Gateway Blvd.
South San Francisco CA 94080
Country 9522 0
United States of America
Phone 9522 0
+1 650 8084072
Fax 9522 0
Email 9522 0
[email protected]
Contact person for scientific queries
Name 450 0
Dr. David Friedland
Address 450 0
Theravance Inc.
901 Gateway Blvd.
South San Francisco CA 94080
Country 450 0
United States of America
Phone 450 0
+1 650 8084063
Fax 450 0
Email 450 0
[email protected]

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
No additional documents have been identified.