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A prospective, multicenter, randomized, double-blind, pilot study to evaluate the safety, the efficacy, the tolerability, and the emergence of resistant gram-negative microorganisms in the bowel in e...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-002988-24

A prospective, multicenter, randomized, double-blind, pilot study to evaluate the safety, the efficacy, the tolerability, and the emergence of resistant gram-negative microorganisms in the bowel in elderly patients with serious community-acquired bacterial pneumonia treated with a short regimen fo ertapenem versus high-dose levofloxacin

Femme et Homme

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Extrait

a. In elderly patients (≥ 65 years old) who are clinically evaluable, to assess the efficacy of ertapenem with respect to high-dose levofloxacin measured as the proportion of patients achieving a favorable clinical response (“cure”) at (a) DOT, and (b) 2 weeks post-DOT (TOC). b. Using serial rectal swabs obtained from patients enrolled in the study who are being treated for CAP, to assess the impact of therapy with ertapenem versus high-dose levofloxacin on the emergence of resistant gram-negative microorganisms in the bowel flora.

Critère d'inclusion

  • Community Acquired Bacterial Pneumonia with criteria of seriousness and great likelihood of polymicrobial or gram-negative microbial etiology

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