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Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)

Primary Purpose

Bacterial Pneumonia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Vancomycin
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Pneumonia focused on measuring Nosocomial pneumonia, MRSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration. Exclusion Criteria: Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization

Sites / Locations

  • Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telavancin

Vancomycin

Arm Description

Outcomes

Primary Outcome Measures

Clinical Response
Clinical Response: Categorical (Cured, Failed or Indeterminate) Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. Indeterminate: Inability to determine outcome

Secondary Outcome Measures

Full Information

First Posted
April 11, 2005
Last Updated
January 14, 2019
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00107952
Brief Title
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Acronym
ATTAIN1
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Pneumonia
Keywords
Nosocomial pneumonia, MRSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
761 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telavancin
Arm Type
Experimental
Arm Title
Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Telavancin
Other Intervention Name(s)
TD-6424, VIBATIV
Intervention Description
Telavancin 10 mg/kg/day IV for up to 21 days.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 1 Gm IV q 12 hrs for up to 21 days
Primary Outcome Measure Information:
Title
Clinical Response
Description
Clinical Response: Categorical (Cured, Failed or Indeterminate) Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. Indeterminate: Inability to determine outcome
Time Frame
7 - 14 days following end of antibiotic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration. Exclusion Criteria: Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Ralph Corey, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29454592
Citation
McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.
Results Reference
derived
PubMed Identifier
27718118
Citation
Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. doi: 10.1007/s40121-016-0133-y. Epub 2016 Oct 7.
Results Reference
derived
PubMed Identifier
24708675
Citation
Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.
Results Reference
derived

Learn more about this trial

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

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