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

October 6 University

Status: Unknown

Conditions: Pneumonia

Treatments: Drug: intermittent dosing linezolid; Drug: Continuous infusion Linezolid

Study type: Interventional

Funder types: Other

Identifiers

NCT04531332

REC-H-PhBSU-20004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 169 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 2 patient groups

Continuous infusion

Experimental group

Description:

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)

Treatment:

Drug: Continuous infusion Linezolid

Intermittent dosing

Active Comparator group

Description:

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

Treatment:

Drug: intermittent dosing linezolid