Efficacy and safety of 7 versus 14 days of antibiotic treatment for bacteremia produced by Pseudomonas aeruginosa: a multicenter, randomized (SHORTEN-2) clinical trial with a DOOR/RADAR analysis.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508441-41-00

Acronym

SHORTEN-II

Enrollment

306

Registered

2024-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-25

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

Conditions

Bacteriemia producida por P. aeruginosa.

Brief summary

Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.

Detailed description

All-cause mortality, clinical cure and treatment failure: Days +30 and +90 after the end of aproppriate antibiotic treatment., Superinfections, serious adverse events, days of hospital stay, and recurrences (proven, probable or possible): Day +90 after the end of aproppriate antibiotic treatment.

Interventions

DRUGZerbaxa 1 g/0.5 g powder for concentrate for solution for infusion

DRUGAzactam 1g polvo para solución inyectable

DRUGCeftazidima SALA 1.000 mg polvo para solución para perfusión EFG

DRUGMeropenem Qilu 1 g polvo para solución inyectable y para perfusión EFG

DRUGColistimetato de sodio Accord 2 millones de UI polvo para solución inyectable y para perfusión EFG

DRUGMEROPENEM QILU 1 g

DRUGpoudre pour solution injectable/pour perfusion

DRUGQuofenix 300 mg powder for concentrate for solution for infusion

DRUGCIPROFLOXACINO KABI 2 mg/ml solución para perfusion

DRUGFetcroja 1 g powder for concentrate for solution for infusion

DRUGQuofenix 450 mg tablets

DRUGImipenem/Cilastatina Aurovitas 500 mg/500 mg polvo para solución para perfusión EFG

DRUGImipenem/Cilastatina Kabi 500/500 mg

DRUGpolvo para solución para perfusión

DRUGciprofloxacino cinfa 750 mg comprimidos recubiertos EFG

DRUGTobramicina NORMON 100 mg/2 ml solución inyectable EFG

DRUGCEFEPIME ACCORD 1 g

DRUGpoudre pour solution injectable/pour perfusion (IM/IV)

DRUGZavicefta 2 g/0.5 g powder for concentrate for solution for infusion

DRUGAmicacina Braun 500 mg Solución inyectable

DRUGLevofloxacino Kabi 5 mg/ml solución para perfusión.

DRUGLEVOFLOXACINO NORMON 500 mg Comprimidos recubiertos con película EFG.

DRUGVaborem 1 g/1 g powder for concentrate for solution for infusion

DRUGAMIKACINE B. BRAUN 2

DRUG5 mg/ml

DRUGsolution pour perfusion

DRUGColistimetato de sodio Altan Pharma 2 millones de UI polvo para solución inyectable y para perfusión

DRUGCefepima Accord 1 g polvo para solución inyectable y para perfusión EFG

DRUGAzactam 1 g Powder for Solution for Injection or Infusion

DRUGTobramicina NORMON 50 mg/2 ml solución inyectable EFG

DRUGCIPROFLOXACINO KABI 2 mg/ml solución para perfusión

DRUGCeftazidima Sala 1.000 mg polvo para solución inyectable EFG

DRUGPiperacilina/Tazobactam Accord 4 g/0

DRUG5 g polvo para solución para perfusión EFG

DRUGMONOFLOX 500 mg comprimidos recubiertos con película EFG

DRUGCiprofloxacino Aurovitas 750 mg comprimidos recubiertos con película EFG

DRUGLevofloxacino Netpharmalab 5mg/ml solución para perfusión EFG

DRUGPiperacilina/Tazobactam Sala 4 g/0

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.	—

Secondary

Measure	Time frame
All-cause mortality, clinical cure and treatment failure: Days +30 and +90 after the end of aproppriate antibiotic treatment., Superinfections, serious adverse events, days of hospital stay, and recurrences (proven, probable or possible): Day +90 after the end of aproppriate antibiotic treatment.	—

Countries

Spain

Outcome results

None listed

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