Clinical Trial: Duration of Antibiotics for the Treatment of Gram-negative Bacilli Bacteremia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Duration of Antibiotics for the Treatment of Gram-negative Bacilli Bacteremia - a Randomized Controlled Trial
Brief Summary: The investigators plan an open label randomized controlled trial to compare short-course antibiotic therapy (<=7 days) versus longer treatment (>7 days). The investigators will include hospitalized patients with gram-negative bacteremia. The investigators primary objective is to investigate the safety and efficacy of short-course antibiotics.
Detailed Summary:
Sponsor: Rabin Medical Center
Current Primary Outcome:
- composite of the following [ Time Frame: Until day 90 after randomization ]The primary outcome is a composite of the following outcome measures
- All -cause mortality [ Time Frame: Until day 90 after randomization ]All- cause mortality
- Treatment Failure [ Time Frame: Until day 90 after randomization ]
Failure including any of the following:
- Relapse: a recurrent bacteraemia due to the same microorganism occurring from day of randomization and until day 9013
- Local suppurative complication that was not present at infection onset (e.g. renal abscess in pyelonephritis, empyema in pneumonia)
- Distant complications of initial infection, defined by growth of the same bacteria as in the initial bacteremia
- Hospital re-admissions or extended hospitalization [ Time Frame: Until day 90 after randomization ]
We will define re-admission as a new hospitalization for any cause occurring more than14 days from start of appropriate antibiotic treatment. Patients hospitalized after day 14 (were never discharged or 7-day regimen who were readmitted between days 7-14) will be counted as failures for this outcome.
We will define re-admission as a new hospitalization for any cause occurring more than14 days from start of appropriate antibiotic treatme
Original Primary Outcome:
- All -cause mortality [ Time Frame: Until day 90 after randomization ]All- cause mortality
- Treatment Failure [ Time Frame: Until day 90 after randomization ]
- Relapse: a recurrent bacteraemia due to the same microorganism occurring from day of randomization and until day 9013
- Local suppurative complication that was not present at infection onset (e.g. renal abscess in pyelonephritis, empyema in pneumonia)
- Distant complications of initial infection, defined by growth of the same bacteria as in the initial bacteremia
- Infection caused by other than gram-negative bacteremia [ Time Frame: Until day 90 after randomization ]Development of either clinically or microbiologically documented infection other than gram-negative bacteremia. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections
Current Secondary Outcome:
- Clostridium difficile associated diarrhea [ Time Frame: Until day 30 after randomization ]Clostridium difficile associated diarrhea
- Development of Antibiotic resistance [ Time Frame: Until day 30 after randomization ]Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the bacteremia episode. Surveillance sampling will not be conducted.
- Carriage of carbapenem resistant Klebsiella pneumonia. [ Time Frame: Until day 30 after randomization ]Carriage of carbapenem resistant Klebsiella pneumonia (screened routinely)
- Total in hospital days [ Time Frame: Until day 90 after randomization. ]Total in hospital days within 30 and 90 days
- Total antibiotic days [ Time Frame: Until day 30 after randomization ]Total antibiotic days
- Adverse events [ Time Frame: Until day 30 after randomization ]
- Any diarrhea
- Liver function test abnormalities, defined as elevated bilirubin x 1.5 of upper limit of normal or transaminases x 2.5 of upper limit of normal
- Antibiotic rash
- Acute kidney injury - defined according to RIFLE criteria as increased creatinine level x 1.5 from baseline or glomerular filtration rate (GFR) decrease >25% or urine output of <0.5 ml/kg/h for 6 hours22
- Infection caused by other than gram-negative bacteremia [ Time Frame: Until day 90 after randomization ]Development of either clinically or microbiologically documented infection other than gram-negative bacteremia. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections
- Number of hospital re-admissions [ Time Frame: Until day 90 after randomization ]Number of hospital re-admissions until day 90
- Functional capacity and time to return to baseline activity [ Time Frame: Until day 30 after randomization ]Functional capacity and time to return to baseline activity
Original Secondary Outcome:
- Clostridium difficile associated diarrhea [ Time Frame: Until day 30 after randomization ]Clostridium difficile associated diarrhea
- Hospital re-admissions [ Time Frame: Until day 90 after randomization ]Number of hospital re-admissions until day 90
- Development of Antibiotic resistance [ Time Frame: Until day 30 after randomization ]Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the bacteremia episode. Surveillance sampling will not be conducted.
- Carriage of carbapenem resistant Klebsiella pneumonia. [ Time Frame: Until day 30 after randomization ]Carriage of carbapenem resistant Klebsiella pneumonia (screened routinely)
- Total in hospital days [ Time Frame: Until day 30 after randomization. ]Total in hospital days
- Total antibiotic days [ Time Frame: Until day 30 after randomization ]Total antibiotic days
- Adverse events [ Time Frame: Until day 30 after randomization ]
- Any diarrhea
- Liver function test abnormalities, defined as elevated bilirubin x 1.5 of upper limit of normal or transaminases x 2.5 of upper limit of normal
- Antibiotic rash
- Acute kidney injury - defined according to RIFLE criteria as increased creatinine level x 1.5 from baseline or glomerular filtration rate (GFR) decrease >25% or urine output of <0.5 ml/kg/h for 6 hours22
Information By: Rabin Medical Center
Dates:
Date Received: November 14, 2012
Date Started: January 2013
Date Completion: July 2019
Last Updated: August 8, 2016
Last Verified: August 2016
- All -cause mortality [ Time Frame: Until day 90 after randomization ]