Efficacy measured by the proportion of subjects in the mCRE-MITT Population at the TOC visit with a response of Success defined according to primary indication. day 12-23 (TOC visit) [clinicaltrials_resource:00024c8e82b3fd5417d62dc385d6ffa7]
Proportion of subjects in mCRE-MITT Population at TOC visit with response of Success, defined as subject whose gram-neg antimicrobials to treat infection are not altered (except dose adjust or modification of Best Available Therapy based on susceptibility within 72hrs of first dose) post randomization due to concerns of microbiological/clinical failure, or tolerability, &:
cUTI/AP; EMA - Microbiological eradication. FDA - Overall Success (clinical cure & microbiological eradication). Eradication defined as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <103 CFU/mL urine (EMA) & <104 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
HABP & VABP; Clinical cure (as above)
Bacteremia; Overall Success (as above, except eradication defined as the demonstration that bacterial pathogen(s) found at baseline is absent with repeat culture)
clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]
Efficacy measured by the proportion of subjects in the mCRE-MITT Population at the TOC visit with a response of Success defined according to primary indication. day 12-23 (TOC visit) [clinicaltrials_resource:00024c8e82b3fd5417d62dc385d6ffa7]
Proportion of subjects in mCRE-MITT Population at TOC visit with response of Success, defined as subject whose gram-neg antimicrobials to treat infection are not altered (except dose adjust or modification of Best Available Therapy based on susceptibility within 72hrs of first dose) post randomization due to concerns of microbiological/clinical failure, or tolerability, &:
cUTI/AP; EMA - Microbiological eradication. FDA - Overall Success (clinical cure & microbiological eradication). Eradication defined as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <103 CFU/mL urine (EMA) & <104 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
HABP & VABP; Clinical cure (as above)
Bacteremia; Overall Success (as above, except eradication defined as the demonstration that bacterial pathogen(s) found at baseline is absent with repeat culture)
Bio2RDF identifier
00024c8e82b3fd5417d62dc385d6ffa7
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:00024c8e82b3fd5417d62dc385d6ffa7
measure [clinicaltrials_vocabulary:measure]
Efficacy measured by the propo ...... cording to primary indication.
time frame [clinicaltrials_vocabulary:time-frame]
day 12-23 (TOC visit)
description
Proportion of subjects in mCRE ...... is absent with repeat culture)
identifier
clinicaltrials_resource:00024c8e82b3fd5417d62dc385d6ffa7
title
Efficacy measured by the propo ...... ication. day 12-23 (TOC visit)
@en
type
label
Efficacy measured by the propo ...... 24c8e82b3fd5417d62dc385d6ffa7]
@en