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NCT01600768 Clinical Trial

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

Gram-Negative Bacterial Infections Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01600768
Other study ID # 200912104M
Secondary ID
Status Recruiting
Phase N/A
First received May 16, 2012
Last updated May 16, 2012
Start date February 2012
Est. completion date December 2015

Study information
Verified date February 2012
Source National Taiwan University Hospital
Contact Shu-Wen Lin, Pharm D.
Phone (02)2312-3456
Email shuwenlin@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Beta-Lactams
infusion time: 30 mins or 1 hr
• Beta-Lactams
infusion time 4 hrs

Locations
Country Name City State
Taiwan NTUH Taipei City

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum concentrations of beta-lactams Determination of serum concentrations of beta-lactams 6 hours No
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