English to Russian Medical Medical: Pharmaceuticals Clinical Trials

No statistically significant PK/PD relationship of per-patient or per-pathogen microbiological response to *zidime exposure in %fT>MIC and to *bactam exposure in %fT>CT of *** mg/L from clinical data in patients with cIAI or cUTI was identified. This was due to the fact that the exposures for nearly all the patients were clustered near the high percentage of time coverage (i.e., well over *number*%) for %fT> *drug combination* MIC for *zidime and %fT>CT of *number* mg/L for *bactam. Also, there were few subjects in the “unfavourable” overall microbiological response group, and there was a similar pattern of overall microbiological response versus exposure (%fT>baseline "drug combination" MIC for *zidime or %fT>CT of *number* or *number* mg/L for *bactam) in both “favourable” and “unfavourable” groups.
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ACRONYMS:

cIAI Complicated intra-abdominal infection

cUTI Complicated urinary tract infection

% fT>CT Percentage of the dosing interval that the free drug concentration (of *bactam) is greater than the critical threshold concentration (for *bactam)

% fT>MIC Percentage of the dosing interval that the free drug concentration (of *zidime) is greater than the minimum inhibitory concentration (for *drug combination*)