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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01600768
Recruitment Status : Unknown
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 17, 2012
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

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).

Condition or disease Intervention/treatment Phase
Gram-Negative Bacterial Infections Drug: Beta-Lactams Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: intermittent infusion Drug: Beta-Lactams
infusion time: 30 mins or 1 hr
Experimental: extended infusion Drug: Beta-Lactams
infusion time 4 hrs

Primary Outcome Measures :
  1. serum concentrations of beta-lactams [ Time Frame: 6 hours ]
    Determination of serum concentrations of beta-lactams

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01600768

Contact: Shu-Wen Lin, Pharm D. (02)2312-3456 ext 88372

NTUH Recruiting
Taipei City, Taiwan, 100
Contact: Shu-Wen Lin, Pharm D.    (02)2312-3456 ext 88372   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Shu-Wen Lin, Pharm D. National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01600768     History of Changes
Other Study ID Numbers: 200912104M
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: February 2012

Keywords provided by National Taiwan University Hospital:
focus of study

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents