Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia

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

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-09-15

Brief Summary

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The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.

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Detailed Description

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Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.

Conditions

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Pneumonia

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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Continuous infusion

Patients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr)

Group Type EXPERIMENTAL

Continuous infusion Linezolid

Intervention Type DRUG

Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )

Intermittent dosing

Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes

Group Type ACTIVE_COMPARATOR

intermittent dosing linezolid

Intervention Type DRUG

Linezolid 600 mg intravenous twice daily

Interventions

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Continuous infusion Linezolid

Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )

Intervention Type DRUG

intermittent dosing linezolid

Linezolid 600 mg intravenous twice daily

Intervention Type DRUG

Other Intervention Names

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intervention control

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to ICUs diagnosed as HAP or VAP
* Chest X-ray/ computed tomography showing new or progressive infiltrate.
* New onset of purulent sputum or change in sputum character.
* Body temperature greater than 38 ℃ or less than 35.5℃.
* White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
* Significant quantitative pathogen cultures from respiratory secretions.

Exclusion Criteria

* Age \<18 years, Pregnancy, Lactation
* Previous known allergic reaction to linezolid
* Creatinine Clearance (CrCl) \<10 mL/min, calculated according to the Cockcroft-Gault formula
* Thrombocytopenia (platelet count less than 80,000/mm3)
* Severe hepatic failure (Child-Pugh C)
* Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
* Acute DIC score \> 4 points or hematological disorder
* Concurrent drug-associated Thrombocytopenia

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No