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Activity of doripenem in patients with baseline bacteraemia in 6 pooled phaseIII pivotal studies

Abstract number: P1546

Umeh O., Kaniga K., Lee M., Ketter N., Quintana A., Redman R.

Objectives: Doripenem (DOR) 500 mg given every 8 hours as a 1-hour infusion was studied and is approved in the US & Europe (EU) for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections in adults, and in the EU as a 1 or 4-hour infusion for nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP). DOR is active in vitro against most bacteria commonly isolated from bacteremic patients (pts). To date, outcomes in the subgroup of DOR-treated pts with concurrent bacteremia and either cIAI, cUTI or NP has not been reported. Here we report the clinical and microbiological (micro) outcomes in a subgroup of pts with bacteremia at baseline (BL) from 6 pooled DOR clinical studies.

Methods: Micro outcomes for all micro evaluable (ME) subjects with BL bacteremia in DOR studies 05–10 were obtained. The ME analysis set excluded pts who received concomitant non study antibiotics. Micro eradication was either defined as the presence of geqslant R: gt-or-equal, slanted1 post-BL negative blood culture or presumed if a patient had no post-BL blood culture but recovered from the index infection. The overall response to treatment in bacteremic and non bacteremic pts was compared.

Results: The table below summarizes the findings.

Overall, DOR was effective in clearing baseline bacteremia. The response to treatment in DOR-treated pts with bacteremia was similar to pts without bacteremia. In contrast, in the comparator arm, there was a trend towards lower clinical cure rates in bacteremic versus non-bacteremic pts; however this comparison is limited by the small sample size.

Conclusion: DOR is a good therapeutic option for subjects with cIAI, cUTI or NP who have concomitant bacteremia at diagnosis.

Table: Summary of clinical cure at TOC and clearance of baseline blood pathogen in ME patients

 DoripenemComparatorDiffa
 Nn%Nn%(%)95% CI
Clearance of blood pathogen(s)
Overall807695.0777192.22.8(-6.1; 11.7)
  cUTI4747100.02323100.00.0 
  cIAI141392.9232295.7-2.8(-24.4; 18.8)
  NP (non-VAP)33100.011981.818.2(-25.8; 62.2)
  VAP161381.3201785.0-3.7(-34.1; 26.6)
Had both clinical cure at TOC and clearance of blood pathogen for subjects with bacteremia at baseline
Overall806885.0775774.011.0(-2.8; 24.8)
  cUTI474493.62323100.0-6.4(-16.6; 3.8)
  cIAI141285.7231773.911.8(-19.6; 43.2)
  NP (non-VAP)33100.011763.636.4(-13.3; 86.0)
  VAP16956.3201050.06.3(-32.1; 44.6)
Clinical cure rates at TOC for subjects without bacteremia
Overall98485887.270658482.74.5(0.9; 8.1)
  cUTI47444994.723120689.25.5(0.7; 10.4)
  cIAI31126384.628524284.9-0.3(-6.5; 5.8)
  NP (non-VAP)685783.8665887.9-4.1(-17.3; 9.2)
  VAP1318967.91247862.95.0(-7.4; 17.5)
aDoripenem minus Comparator.

Session Details

Date: 10/04/2010
Time: 00:00-00:00
Session name: Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases
Subject:
Location: Vienna, Austria, 10 - 13 April 2010
Presentation type:
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