915. Relationship between Time to Clinical Response and Outcomes among PORT III and IV Patients (Pts) with Community-Acquired Bacterial Pneumonia (CABP)
Session: Poster Abstract Session: Respiratory Infections
Friday, October 4, 2013
Room: The Moscone Center: Poster Hall C

Background: Recent FDA guidance for CABP phase III trials endorses the use of an early clinical response endpoint between days 3-5. However, scant data exist on the relationship between time to clinical response, as specified by the FDA, & outcomes among pts with CABP. The intent of this study was to examine the relationship between time to clinical response & outcomes among PORT III & IV pts with CABP & determine the delay in response that was associated with increased incidence of adverse outcomes.

Methods: A cohort study of hospitalized pts with CABP that received ceftriaxone (CRO) & azithromycin (AZM) was performed between Jan 08 & Feb 12 at an academic medical center. Inclusion criteria: age ≥ 18 yrs; met ATS/IDSA criteria for CABP; received ≥ 24 hrs CRO & AZM. Pts with CABP due to CRO resistant pathogens were excluded. Time to clinical response was based on symptomatology (≥ 1 improved and none worsening: cough, shortness of breath, chest pain, sputum production) & clinical stability (temp ≤ 37.8C, HR ≤ 100 bpm, SBP ≥ 90 mmHg, RR ≤ 24 breaths/min, O2 sat ≥ 90% or PaO2 ≥ 60 mmHg, normal mental status) for 24 h. Classification & regression tree (CART) was used to determine the delay in response associated with the greatest risk of adverse outcomes (in-hospital mortality & CABP related readmission). The relationship between time to clinical response & hospital LOS was also examined.

Results: 251 pts met study criteria. Mean (SD) age: 65.9 (14.5) yrs. Sex-male: 59%. PORT risk classes III & IV: 41% & 59%. Co-morbidities: COPD (36%); diabetes (34%); CHF (29%); renal disease (26%); neoplasm (17%); and liver disease (6%). Adverse outcomes occurred in 11.6% of pts. In the CART analysis, adverse clinical outcomes were significantly higher among pts who did not respond by day 5 vs those that responded by day 5 (22.4% vs 6.9%, respectively, P=0.001). Both in-hospital mortality & CABP related readmission were higher among day 5 non-responders vs responders. A positive relationship was found between time to clinical response & both mean & median LOS (P<0.05 for both comparisons).

Conclusion: Among PORT III & IV pts with CABP that received CRO & AZM, patients that did not achieve clinical response by day 5 had a 3-fold increase in adverse outcomes. Time to clinical response was also associated with LOS.

 

Evan Zasowski, PharmD1, Jill Butterfield, PharmD1, Louise-Anne Mcnutt, PhD2, Jason Cohen, DO3, Leon Cosler, PhD1, Joseph Gottwald1, Wen-Zhen Chen1 and Thomas Lodise, PharmD4, (1)Albany College of Pharmacy and Health Sciences, Albany, NY, (2)State University of New York At Albany School of Public Health, Albany, NY, (3)Albany Medical Center, Albany, NY, (4)Albany College of Pharmacy, Albany, NY

Disclosures:

E. Zasowski, None

J. Butterfield, None

L. A. Mcnutt, None

J. Cohen, Forest Research Institute: Investigator, Research grant

L. Cosler, None

J. Gottwald, None

W. Z. Chen, None

T. Lodise, Forest Research Institute: Investigator, Research grant

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