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

National Taiwan University

Status: Unknown

Conditions: Gram-Negative Bacterial Infections

Treatments: Drug: Beta-Lactams

Study type: Interventional

Funder types: Other

Identifiers

NCT01600768

200912104M

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

intermittent infusion

Active Comparator group

Treatment:

Drug: Beta-Lactams

Drug: Beta-Lactams

extended infusion

Experimental group

Treatment:

Drug: Beta-Lactams

Drug: Beta-Lactams