Skip to content

Piperacillin-tazobactam and temocillin as carbapenem-alternatives for the treatment of severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae in the intensive care unit (PITAGORE)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511866-36-00
Acronym
APHP211034
Enrollment
600
Registered
2024-09-27
Start date
2023-03-11
Completion date
Unknown
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients hospitalized in ICU with ESBL-producing Enterobacteriaceae severe infection

Brief summary

Mortality at 30 days from the date of randomization

Detailed description

90-day mortality rate., Relapse rates of ESBL infection at day 30., Clinical failure rate at day 30 (relapse of ESBL infection or death between randomization and day 30)., Rate of antibiotic allergy at day 30., Rate of adverse events at day 30,, ICU length of stay, Hospital length of stay, ICU-free days at day 30, Hospital-free days at day 30, Antibiotic-free days at day 30, Kinetics of organ failure from randomization to day 30 post-randomization, assessed by the sequential organ failure assessment (SOFA) score and its components, Rate of faecal colonization with carbapenem-resistant Gram-negative bacilli at end of treatment, ICU discharge and day 90, Rate of Clostridium difficile infection at day 90., Rate of secondary nosocomial infection at day 90, Proportion of patients in whom duration of antimicrobial treatment of the index episode (the episode that led to inclusion in the study) has been exceeded compared to the recommended duration., Proportion of patients who change their treatment before the recommended duration without relapse (= cross-over)

Interventions

DRUGNEGABAN 2 g
DRUGMEROPENEM ARROW 1 g
DRUGpoudre pour solution injectable / pour perfusion

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mortality at 30 days from the date of randomization

Secondary

MeasureTime frame
90-day mortality rate., Relapse rates of ESBL infection at day 30., Clinical failure rate at day 30 (relapse of ESBL infection or death between randomization and day 30)., Rate of antibiotic allergy at day 30., Rate of adverse events at day 30,, ICU length of stay, Hospital length of stay, ICU-free days at day 30, Hospital-free days at day 30, Antibiotic-free days at day 30, Kinetics of organ failure from randomization to day 30 post-randomization, assessed by the sequential organ failure assessment (SOFA) score and its components, Rate of faecal colonization with carbapenem-resistant Gram-negative bacilli at end of treatment, ICU discharge and day 90, Rate of Clostridium difficile infection at day 90., Rate of secondary nosocomial infection at day 90, Proportion of patients in whom duration of antimicrobial treatment of the index episode (the episode that led to inclusion in the study) has been exceeded compared to the recommended duration., Proportion of patients who change their tre

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026