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

This study is currently recruiting participants.
Verified February 2012 by National Taiwan University Hospital
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

Resource links provided by NLM:

U.S. FDA Resources

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
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
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

No publications provided

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:
Bacterial Infections
Gram-Negative Bacterial Infections
Lactams
Beta-Lactams
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013