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Short course antibiotic treatment of Gram-negative bacteremia: A multicenter, randomized, non-blinded, non-inferiority interventional study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514900-16-00
Acronym
2019-003282-17
Enrollment
380
Registered
2024-07-25
Start date
2024-07-25
Completion date
Unknown
Last updated
2025-09-12

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

Conditions

Gram-negative Bacteremia

Brief summary

90-day survival without clinical or microbiological failure to treatment

Detailed description

Mortality (timeframe 14, 30 and 90 days), Total duration of antibiotic treatment (timeframe 90 days), Type of antibiotic treatment (timeframe 90 days), Duration of antibiotic treatment (timeframe 90 days), Total length of hospital stay (timeframe 90 days), Hospital re-admission, Antibiotic adverse events (timeframe 30 and 90 days), Use of antimicrobials after discharge (timeframe 90 days), Severe adverse events (timeframe 90 days), Acute kidney injury (timeframe 90 days), Clostridioides difficile infection - Number of participants with Clostridioides difficile infection (timeframe 90 days), Multidrug-resistance organism: Multidrug-resistance organism defined as identification of resistant bacteria in a clinical specimen obtained only from a clinical infection. (timeframe 90 days)

Interventions

DRUGSelexid
DRUGCiprofloxacin Fresenius Kabi
DRUGAmpicillin "PCD"
DRUGopløsning
DRUGMeropenem ”Stada”
DRUGSulfametizol ”Alternova”
DRUGPiperacillin/Tazobactam "Stragen"
DRUGCiprofloxacin "HEXAL"
DRUGCeftazidim "Fresenius Kabi"
DRUGHexamycin
DRUGinjektionsvæske
DRUGNebcina
DRUGNitrofurantoin "EQL Pharma"

Sponsors

Region Hovedstaden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
90-day survival without clinical or microbiological failure to treatment

Secondary

MeasureTime frame
Mortality (timeframe 14, 30 and 90 days), Total duration of antibiotic treatment (timeframe 90 days), Type of antibiotic treatment (timeframe 90 days), Duration of antibiotic treatment (timeframe 90 days), Total length of hospital stay (timeframe 90 days), Hospital re-admission, Antibiotic adverse events (timeframe 30 and 90 days), Use of antimicrobials after discharge (timeframe 90 days), Severe adverse events (timeframe 90 days), Acute kidney injury (timeframe 90 days), Clostridioides difficile infection - Number of participants with Clostridioides difficile infection (timeframe 90 days), Multidrug-resistance organism: Multidrug-resistance organism defined as identification of resistant bacteria in a clinical specimen obtained only from a clinical infection. (timeframe 90 days)

Countries

Denmark

Outcome results

None listed

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