NCT01600768UnknownNot Applicable
Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients
National Taiwan University Hospital1 site in 1 country100 target enrollmentStarted: February 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- serum concentrations of beta-lactams
Study Overview
Brief Summary
The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (> 18 years)
- •Admitted on the intensive care unit
- •Starting a treatment with beta-lactams antibiotics
- •Signed informed consent
- •Expected to live > 3 days
Exclusion Criteria
- •renal insufficiency (estimated clearance < 20 ML /MIN)
- •renal replacement therapy
- •ANC < 1000 103 µl
- •pregnancy
- •drug abuse
Arms & Interventions
intermittent infusion
Active Comparator
Intervention: Beta-Lactams (Drug)
extended infusion
Experimental
Intervention: Beta-Lactams (Drug)
Outcomes
Primary Outcomes
serum concentrations of beta-lactams
Time Frame: 6 hours
Determination of serum concentrations of beta-lactams
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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