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

Not Applicable

• Conditions: Gram-Negative Bacterial Infections
• Interventions: Drug: Beta-Lactams

• Registration Number: NCT01600768
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study Start: 2012-02
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-16
• Last Update Submitted: 2012-05-16
• Study First Posted: 2012-05-17
• Last Update Posted: 2012-05-17
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• renal insufficiency (estimated clearance < 20 ML /MIN)
• renal replacement therapy
• ANC < 1000 103 µl
• pregnancy
• drug abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent infusion	Beta-Lactams	-
extended infusion	Beta-Lactams	-

Primary Outcome Measures

Name	Time	Method
serum concentrations of beta-lactams	6 hours	Determination of serum concentrations of beta-lactams

Trial Locations

Locations (1)

NTUH; 🇨🇳 Taipei City, Taiwan