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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: May 16, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
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 Intervention
Gram-Negative Bacterial Infections Drug: Beta-Lactams

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intermittent infusion Drug: Beta-Lactams
infusion time: 30 mins or 1 hr
Experimental: extended infusion Drug: Beta-Lactams
infusion time 4 hrs


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: National Taiwan University Hospital Identifier: NCT01600768     History of Changes
Other Study ID Numbers: 200912104M
Study First Received: May 16, 2012
Last Updated: May 16, 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 processed this record on September 19, 2017