295. Outcome Analysis of Hospital-Acquired Pneumonia Patients Meeting the ATS/IDSA Diagnostic Criteria in the ATTAIN Studies of Telavancin
Session: Poster Abstract Session: Antimicrobial Therapy: Clinical Studies
Friday, October 21, 2011
Room: Poster Hall B1
Background: The ATTAIN program, modelled on a previous registration trial (1), compared telavancin (TLV) with vancomycin (VAN) for treatment of hospital-acquired pneumonia (HAP) due to Gram-positive pathogens (2). The published ATS/IDSA criteria for diagnosis of pneumonia (3) have been shown to provide a clinically acceptable balance of sensitivity and specificity in identifying patients who should be treated empirically. This post-hoc analysis examined the clinical outcomes in the subset of patients who met ATS/IDSA criteria enrolled in the ATTAIN studies.

Methods: The ATTAIN studies were two methodologically identical, randomized, double-blind, Phase 3 studies. Adult patients with HAP due to presumed or confirmed Gram-positive pathogens were randomized to TLV or VAN. The All-Treated (AT) population received at least one dose of study medication. The ATS/IDSA criteria are: presence of new or progressive radiographic infiltration at baseline, plus at least two of the following: fever > 38°C, WBC > 10,000/mm3 or < 4,000/mm3, and purulent respiratory secretions.

Results: A total of 1289 (86%) of the original 1503 ATTAIN AT population met the ATS/IDSA criteria. At study entry, the ATS/IDSA population had baseline and demographic characteristics that were similar to the overall ATTAIN population. Cure rates, mortality during the study, rates of adverse events (AE), serious adverse events (SAE) and AE leading to discontinuation (DC) are displayed in the table.

Table: 

 

Study 0015

Study 0019

 

TLV (n=309)

VAN (n=316)

TLV (n=327)

VAN (n=337)

Cured

58.9%

58.2%

59.7%

59.6%

Difference  (95% CI)

0.7% (-7.1, 8.4)

0.1% (-7.4, 7.6)

Died

19.7%

18.0%

18.8%

21.2%

Difference  (95% CI)

1.7% (-4.4, 7.8)

-2.5% (-8.6, 3.6)

AE

87%

85%

76%

78%

SAE

33%

24%

28%

29%

AE→DC

9%

4%

7%

6%

Conclusion: In a large subset of the ATTAIN study population meeting the ATS/IDSA criteria for diagnosis of pneumonia, treatment with TLV resulted in similar cure rates, mortality and incidences of adverse events compared to VAN. These post-hoc data support the conclusions of the original ATTAIN analyses, which demonstrated non-inferiority of TLV vs VAN.

References:

  1. Clin Infect Dis 2001;32:402-12
  2. Clin Infect Dis 2011;52:31-40
  3. Am J Respir Crit Care Med 2005;171:388-416

Subject Category: C. Clinical studies of bacterial infections and antibacterials including sexually transmitted diseases and mycobacterial infections (surveys, epidemiology, and clinical trials)

Steven L. Barriere1, Ethan Rubinstein2, Alan Hopkins1, G. Ralph Corey3, Nkechi Azie4 and Martin E. Stryjewski3,5, (1)Theravance, Inc., South San Francisco, CA, (2)University of Manitoba, Winnipeg, MB, Canada, (3)Duke Clinical Research Institute, Durham, NC, (4)Astellas Pharma Global Development, Inc., Deerfield, IL, (5)Centro de Educación Médica e Investigaciones Clínicas, Buenos Aires, Argentina

Disclosures:

S. L. Barriere, Theravance: Employee, Salary

E. Rubinstein, Astellas: Scientific Advisor and Speaker's Bureau, Payment for advisory board and Speaker honorarium
Pfizer: Investigator, Scientific Advisor and Speaker's Bureau, Payment for advisory board and Speaker honorarium
Bayer: Scientific Advisor and Speaker's Bureau, Payment for advisory board and Speaker honorarium
BiondVax: Scientific Advisor, Payment for advisory board
Atox: Scientific Advisor, Payment for advisory board
Theravance: Scientific Advisor, Payment for advisory board

A. Hopkins, Theravance: Employee and Shareholder, Salary

G. R. Corey, Theravance: Consultant, Investigator and Publication development, Consulting fee, Grant recipient, Research grant, Research support and Travel expenses reimbursement
Pfizer: Investigator and Scientific Advisor, Payment for advisory board and Research support
AstraZeneca: Consultant and Scientific Advisor, Consulting fee
Astellas: Consultant and Scientific Advisor, Consulting fee
Durata: Consultant and Scientific Advisor, Consulting fee
Furiex: Consultant and Scientific Advisor, Consulting fee
Gilead: Consultant and Scientific Advisor, Consulting fee
Nabriva: Consultant and Scientific Advisor, Consulting fee
DRL: Consultant and Scientific Advisor, Consulting fee
Rib-X: Consultant and Scientific Advisor, Consulting fee
Seachaid: Consultant and Scientific Advisor, Consulting fee
Cempra: Investigator, Research support
Cerexa: Investigator, Research support
Cubist: Investigator, Research support
GSK: Investigator, Research support
Inimex: Investigator, Research support
Innocol: Investigator, Research support
Merck: Investigator, Research support
Polymedix: Investigator, Research support
Trius: Investigator, Research support

N. Azie, Astellas: Employee, Salary

M. E. Stryjewski, Theravance: Consultant, Investigator and Publication development, Consulting fee, Research support and Travel expenses reimbursement
Trius Therapeutics: Consultant, Consulting fee
The Medicines Company: Consultant, Consulting fee

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.