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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 because the information has not been verified recently.
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01600768
First received: May 16, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01600768

Contacts
Contact: Shu-Wen Lin, Pharm D. (02)2312-3456 ext 88372 shuwenlin@ntu.edu.tw

Locations
Taiwan
NTUH Recruiting
Taipei City, Taiwan, 100
Contact: Shu-Wen Lin, Pharm D.    (02)2312-3456 ext 88372    shuwenlin@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shu-Wen Lin, Pharm D. National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01600768     History of Changes
Other Study ID Numbers: 200912104M 
Study First Received: May 16, 2012
Last Updated: May 16, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
focus of study

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

ClinicalTrials.gov processed this record on September 27, 2016