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PipEracillin Tazobactam versus mERoPENem for treatment of bloodstream infections caused by cephalosporin-resistant Enterobacteriaceae - a non-inferiority randomized controlled trial (PETERPEN)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518583-13-00
Acronym
PETERPEN
Enrollment
490
Registered
2025-09-03
Start date
2025-11-18
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Patients with bacteremia

Brief summary

Treatment failure at day 7 from randomization. Treatment modifications before day 7 will be discouraged, but they will be allowed according to treating physicians’ discretion

Detailed description

•All-cause mortality 14,30,90days •Treatment failure 7,14,30days •Microbiological failure 7,14days •Relapse 30,90days •Clostridium difficile associated diarrhea till 90days •Development of either clinically or microbiologically documented infection other than Gram-negative bacteremia within 90days •Number of hospital re-admissions until day90, •Development of resistance •Carriage of carbapenemase-producing Enterobacteriaceae and non-CPE CRE in-hospital till day90 •Total in-hospital days within 30,90days •Total antibiotic days within 30,90days •Adverse events at 30days

Interventions

DRUGPiperacillina e Tazobactam Aurobindo 2 g/0
DRUG25 g polvere per soluzione per infusione

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Treatment failure at day 7 from randomization. Treatment modifications before day 7 will be discouraged, but they will be allowed according to treating physicians’ discretion

Secondary

MeasureTime frame
•All-cause mortality 14,30,90days •Treatment failure 7,14,30days •Microbiological failure 7,14days •Relapse 30,90days •Clostridium difficile associated diarrhea till 90days •Development of either clinically or microbiologically documented infection other than Gram-negative bacteremia within 90days •Number of hospital re-admissions until day90, •Development of resistance •Carriage of carbapenemase-producing Enterobacteriaceae and non-CPE CRE in-hospital till day90 •Total in-hospital days within 30,90days •Total antibiotic days within 30,90days •Adverse events at 30days

Countries

Italy

Outcome results

None listed

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