379. Regional Pathogen Variations in a Large Phase III Hospital-acquired Pneumonia Clinical Program: The ATTAIN Experience
Session: Poster Session: Hospital-acquired and Transplant Infections
Friday, October 30, 2009: 12:00 AM
Room: Poster Hall A
Background: Hospital-acquired pneumonia (HAP) is a major cause of morbidity and mortality world-wide. Few global clinical trials in HAP have demonstrated the frequency of underlying pathogens in patients enrolled across different geographic regions.
Methods: ATTAIN 1 and 2 were international phase III trials designed methodologically identical (randomized, double-blind and parallel-group) to compare the efficacy and safety of telavancin and vancomycin for treatment of HAP due to Gram-positive pathogens. This analysis compared the frequency of baseline pathogens in the modified all-treated population (patients who received ≥ 1 dose of study medication and had a baseline pathogen identified), stratified by geographic region
Results: The frequency of major pathogens in the HAP trials per geographical region is shown in the table.
Conclusions: While MRSA was the most commonly encountered respiratory pathogen (except in the Middle East, where MSSA predominated), there was substantial variation in the frequency of Gram-negative pathogens between geographic regions. P. aeruginosa and Acinetobacter spp. were more common outside of the U.S., especially in Latin America and Asia. Acinetobacter spp were rare in the U.S.
Table
Frequency by Geographic Region, n (%)
PathogenNorth America (N=236)Latin America (N=173)Europe (N=271)Middle East (N=97)Asia (N=254)Other (N=58)*
MRSA110 (46.6)92 (53.2)105 (38.7)17 (17.5)111 (43.7)29 (50)
MSSA59 (25)39 (22.5)91 (33.6)44 (45.4)25 (9.8)8 (13.8)
PAE28 (11.9)39 (22.5)41 (15.1)20 (21.6)69 (27.2)8 (13.8)
ACB4 (1.7)36 (20.8)25 (9.2)14 (14.4)39 (15.4)3 (5.2)
KLEB10 (4.2)10 (5.8)26 (9.6)12 (12.4)33 (13)2 (3.4)
*Australia and South Africa
MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-sensitive S. aureus; PAE, Pseudomonas aeruginosa; ACB, Acinetobacter spp., KLEB, Klebsiella pneumoniae
Steven Barriere, Theravance, Inc., South San Francisco, CA, Marcelo Rocha, MD, Pavilhão Pereira Filho, Irmandade da Santa Casa, Porto Alegre RS, Brazil, Ethan Rubinstein, University of Manitoba, Winnipeg, MB, Canada, Jean-Louis Vincent, MD, Erasme University Hospital and  M. G. Rocha,
HOSPIRA Role(s): Investigator, Other, contract as clinical investigator of trials, Received: Grant Recipient.
BRONCUS Role(s): Consultant, Received: Consulting Fee.
NOVARTIS Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Other, contract as clinical investigator of trials, Received: Other Financial Benefit.
PFIZER Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Other, contract as clinical investigator of trials, Received: Other Financial Benefit.
ALTANA Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Other, contract as clinical investigator of trials, Received: Other Financial Benefit.
THERAVANCE, INC. Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Other, contract as clinical investigator of trials, Received: Other Financial Benefit.
S. L. Barriere,
THERAVANCE, INC. Role(s): Employee.
E. Rubinstein,
BAYER Role(s): Consultant, Received: Consulting Fee.
JOHNSON & JOHNSON Role(s): Consultant, Received: Consulting Fee.
PFIZER Role(s): Consultant, Received: Consulting Fee.
THERAVANCE, INC. Role(s): Consultant, Received: Consulting Fee.
ASTELLAS PHARMA US, INC. Role(s): Consultant, Received: Consulting Fee.
WYETH PHARMACEUTICALS Role(s): Consultant, Received: Consulting Fee.
BION VAX Role(s): Consultant, Received: Consulting Fee.
ATOX Role(s): Consultant, Received: Consulting Fee.
J. Vincent,
THERAVANCE, INC. Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Speaker Honorarium.