Telavancin Hospital-Acquired Pneumonia Trials: Impact of Gram-Negative Infections and Inadequate Gram-Negative Coverage on Clinical Efficacy and All-Cause Mortality

December 20, 2015 at 4:54 pm

Clinical Infectious Diseases SEP 15, 2015 V.61 Suppl.2 S87-S93

Melinda K. Lacy, Martin E. Stryjewski, Whedy Wang, Thomas C. Hardin, Boris Nogid, David R. Luke, Andrew F. Shorr, G. Ralph Corey, and Steven L. Barriere

1Theravance Biopharma US, South San Francisco, California

2Department of Medicine, Section of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno” (CEMIC), Ciudad Autónoma de Buenos Aires, Argentina

3Pulmonary and Critical Care Medicine, Washington Hospital Center, Washington D.C

4Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina

Correspondence: Melinda K. Lacy, PharmD, Theravance Biopharma US, 901 Gateway Blvd, S San Francisco, CA 94080 (mlacy@theravance.com).

Background

When hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is caused by gram-positive and gram-negative pathogens or both (mixed infections), the adequacy of gram-negative coverage (GNC) can confound the assessment of a gram-positive agent under study. This analysis examines the influence of gram-negative infections and the adequacy of GNC on clinical efficacy and all-cause mortality in the telavancin HABP/VABP phase 3 ATTAIN trials (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia).

Methods

This post hoc analysis evaluated 3 patient groups from ATTAIN: (1) gram-positive–only infections, (2) gram-positive–only and mixed infections-adequate GNC, and (3) gram-negative–only infections and mixed infections with inadequate GNC. For each, clinical efficacy at test of cure and all-cause mortality at day 28 were compared for telavancin and vancomycin.

Results/Conclusions

In the ATTAIN safety population there were 16 more deaths in the telavancin arms than in the vancomycin arms. Of these, 13 were in patients with gram-negative–only infections (n = 9) or with mixed infections and inadequate GNC (n = 4) and all had estimated baseline creatinine clearances of <30ml/min. Based on this analysis, clinical response and all-cause mortality could be confounded because there were more patients with gram-negative pathogens at baseline and more patients received inadequate treatment of these gram-negative infections in the telavancin groups.

PDF

http://cid.oxfordjournals.org/content/61/suppl_2/S87.full.pdf

Entry filed under: Antimicrobianos, Bacterias, Bacteriemias, Health Care-Associated Infections, Infecciones nosocomiales, Infecciones respiratorias, Metodos diagnosticos, Resistencia bacteriana, REVIEWS, Update. Tags: .

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