Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000323628
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
6/09/2005
Date last updated
7/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram positive Skin and Skin Structure Infections with a Focus on Patients with Infections Due to Methicillin resistant Staphylococcus aureus (ATLAS I)
Scientific title
A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram positive Skin and Skin Structure Infections with a Focus on Patients with Infections Due to Methicillin resistant Staphylococcus aureus (ATLAS I)
Secondary ID [1] 140 0
0017
Universal Trial Number (UTN)
Trial acronym
ATLAS I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complicated Gram positive Skin and Skin Structure Infections 411 0
Condition category
Condition code
Skin 482 482 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telavancin 10 mg/kg IV for 7 to 14 days
Intervention code [1] 332 0
Treatment: Drugs
Comparator / control treatment
Vancomycin 1 g q 12 hr IV for 7 to 14 days
Control group
Active

Outcomes
Primary outcome [1] 553 0
Clinical response
Timepoint [1] 553 0
At the end of therapy
Secondary outcome [1] 1171 0
Safety and tolerability
Timepoint [1] 1171 0
Baseline, q 3 d, End of Therapy, and Test of cure
Secondary outcome [2] 1172 0
Duration of treatment
Timepoint [2] 1172 0
End of therapy
Secondary outcome [3] 1173 0
Time to resolution of fever
Timepoint [3] 1173 0
From baseline through Test of cure visit.
Secondary outcome [4] 1174 0
Total signs and symptoms score
Timepoint [4] 1174 0
On Days 1-4
Secondary outcome [5] 1175 0
Change in size of primary infection site
Timepoint [5] 1175 0
From baseline on Days 2-4, at end of therapy and at the test of cure visit 7-14 days following the end of treatment.

Eligibility
Key inclusion criteria
Diagnosis of complicated skin and skin structure infections with MRSA either suspected or confirmed as the major cause of the infection:Require at least 7 days of IV antibiotic treatment.
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 or is 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
1/01/2005
Actual
19/01/2005
Date of last participant enrolment
Anticipated
Actual
15/05/2006
Date of last data collection
Anticipated
Actual
12/06/2006
Sample size
Target
750
Accrual to date
Final
862
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 548 0
Commercial sector/Industry
Name [1] 548 0
Theravance, Inc
Country [1] 548 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] 442 0
None
Name [1] 442 0
none
Address [1] 442 0
Country [1] 442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1550 0
Princess Alexandra Hospital
Ethics committee address [1] 1550 0
Ethics committee country [1] 1550 0
Australia
Date submitted for ethics approval [1] 1550 0
Approval date [1] 1550 0
02/11/2004
Ethics approval number [1] 1550 0
Ethics committee name [2] 1551 0
Prince of Wales Hospital
Ethics committee address [2] 1551 0
Ethics committee country [2] 1551 0
Australia
Date submitted for ethics approval [2] 1551 0
Approval date [2] 1551 0
Ethics approval number [2] 1551 0
Ethics committee name [3] 1552 0
Gold Coast Hospital
Ethics committee address [3] 1552 0
Ethics committee country [3] 1552 0
Australia
Date submitted for ethics approval [3] 1552 0
Approval date [3] 1552 0
Ethics approval number [3] 1552 0
Ethics committee name [4] 1553 0
Flinders Medical Centre
Ethics committee address [4] 1553 0
Ethics committee country [4] 1553 0
Australia
Date submitted for ethics approval [4] 1553 0
Approval date [4] 1553 0
Ethics approval number [4] 1553 0
Ethics committee name [5] 1554 0
South Metropolitan Area Health Service, Fremantle Hospital
Ethics committee address [5] 1554 0
Ethics committee country [5] 1554 0
Australia
Date submitted for ethics approval [5] 1554 0
Approval date [5] 1554 0
Ethics approval number [5] 1554 0
Ethics committee name [6] 1555 0
Cairns Base Hospital
Ethics committee address [6] 1555 0
Ethics committee country [6] 1555 0
Australia
Date submitted for ethics approval [6] 1555 0
Approval date [6] 1555 0
Ethics approval number [6] 1555 0
Ethics committee name [7] 1556 0
Repatriation General Hospital
Ethics committee address [7] 1556 0
Ethics committee country [7] 1556 0
Australia
Date submitted for ethics approval [7] 1556 0
Approval date [7] 1556 0
Ethics approval number [7] 1556 0
Ethics committee name [8] 1557 0
Wesley Hospital
Ethics committee address [8] 1557 0
Ethics committee country [8] 1557 0
Australia
Date submitted for ethics approval [8] 1557 0
Approval date [8] 1557 0
Ethics approval number [8] 1557 0
Ethics committee name [9] 1558 0
Peninsula Clinical Research Centre
Ethics committee address [9] 1558 0
Ethics committee country [9] 1558 0
Australia
Date submitted for ethics approval [9] 1558 0
Approval date [9] 1558 0
Ethics approval number [9] 1558 0
Ethics committee name [10] 1559 0
Royal Melborne Hospital
Ethics committee address [10] 1559 0
Ethics committee country [10] 1559 0
Australia
Date submitted for ethics approval [10] 1559 0
Approval date [10] 1559 0
Ethics approval number [10] 1559 0
Ethics committee name [11] 1560 0
Royal Perth Hospital
Ethics committee address [11] 1560 0
Ethics committee country [11] 1560 0
Australia
Date submitted for ethics approval [11] 1560 0
Approval date [11] 1560 0
Ethics approval number [11] 1560 0
Ethics committee name [12] 1561 0
Geelong Hosptial
Ethics committee address [12] 1561 0
Ethics committee country [12] 1561 0
Australia
Date submitted for ethics approval [12] 1561 0
Approval date [12] 1561 0
Ethics approval number [12] 1561 0
Ethics committee name [13] 1562 0
Austin Hospital
Ethics committee address [13] 1562 0
Ethics committee country [13] 1562 0
Australia
Date submitted for ethics approval [13] 1562 0
Approval date [13] 1562 0
Ethics approval number [13] 1562 0

Summary
Brief summary
A large multinational, double-blind, randomized Phase III clinical study designed to compare the efficacy and safety of telavancin (10mg/kg IV once daily) versus vancomycin (1gm IV q12 hr) in adult patients with complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.

The primary objective of the study was to compare the efficacy and safety of telavancin to vancomycin in the treatment of adults with complicated Gram positive skin and skin structure infections with an emphasis on patients with infections due to methicillin resistant Staphylococcus aureus (MRSA). A key secondary objective of this study was to pool the data from this study with data from a second study of identical design (Study 0018) and to assess the superiority of telavancin to vancomycin in patients with MRSA infections.

Patients were assessed for clinical response by assessing a patient’s signs and symptoms at the specified evaluation compared to their Baseline evaluation. A cure consisted of resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary. Not cured meant there was an inadequate response to study therapy and Indeterminate meant the outcome was not able to be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35540 0
Dr G. Ralph Corey
Address 35540 0
Duke University Medical Center
North Carolina
Country 35540 0
United States of America
Phone 35540 0
+1 (919) 668-7174
Fax 35540 0
Email 35540 0
corey001@mc.duke.edu
Contact person for public queries
Name 9521 0
Dr Christina Slover or Mia Elliott
Address 9521 0
Theravance Biopharma Ireland Limited
Connaught House 1 Burlington Road
Dublin 4 D04 C5Y6
Country 9521 0
Ireland
Phone 9521 0
+353 (0)1 539 4800
Fax 9521 0
Email 9521 0
MedInfo@theravance.com
Contact person for scientific queries
Name 449 0
Dr Christina Slover
Address 449 0
Theravance Biopharma Ireland Limited
Connaught House 1 Burlington Road
Dublin 4 D04 C5Y6
Country 449 0
Ireland
Phone 449 0
+353 (0)1 539 4800
Fax 449 0
Email 449 0
MedInfo@theravance.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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