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Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients

Primary Purpose

Gram-Negative Bacterial Infections

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Beta-Lactams
Beta-Lactams
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Negative Bacterial Infections focused on measuring focus of study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NTUHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

intermittent infusion

extended infusion

Arm Description

Outcomes

Primary Outcome Measures

serum concentrations of beta-lactams
Determination of serum concentrations of beta-lactams

Secondary Outcome Measures

Full Information

First Posted
May 16, 2012
Last Updated
May 16, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01600768
Brief Title
Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Negative Bacterial Infections
Keywords
focus of study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intermittent infusion
Arm Type
Active Comparator
Arm Title
extended infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Beta-Lactams
Intervention Description
infusion time: 30 mins or 1 hr
Intervention Type
Drug
Intervention Name(s)
Beta-Lactams
Intervention Description
infusion time 4 hrs
Primary Outcome Measure Information:
Title
serum concentrations of beta-lactams
Description
Determination of serum concentrations of beta-lactams
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Wen Lin, Pharm D.
Phone
(02)2312-3456
Ext
88372
Email
shuwenlin@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Wen Lin, Pharm D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NTUH
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Wen Lin, Pharm D.
Phone
(02)2312-3456
Ext
88372
Email
shuwenlin@ntu.edu.tw

12. IPD Sharing Statement

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Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients

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