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

NCT ID: NCT01600768

Last Updated: 2012-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Gram-Negative Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intermittent infusion

Group Type ACTIVE_COMPARATOR

Beta-Lactams

Intervention Type DRUG

infusion time: 30 mins or 1 hr

extended infusion

Group Type EXPERIMENTAL

Beta-Lactams

Intervention Type DRUG

infusion time 4 hrs

Interventions

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Beta-Lactams

infusion time: 30 mins or 1 hr

Intervention Type DRUG

Beta-Lactams

infusion time 4 hrs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu-Wen Lin, Pharm D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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NTUH

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shu-Wen Lin, Pharm D.

Role: CONTACT

(02)2312-3456 ext. 88372

Facility Contacts

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Shu-Wen Lin, Pharm D.

Role: primary

(02)2312-3456 ext. 88372

Other Identifiers

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200912104M

Identifier Type: -

Identifier Source: org_study_id

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