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

Not Applicable

• Conditions: Pneumonia
• Interventions: Drug: Continuous infusion Linezolid; Drug: intermittent dosing linezolid

• Registration Number: NCT04531332
• Lead Sponsor: October 6 University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion	Continuous infusion Linezolid	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)
Intermittent dosing	intermittent dosing linezolid	Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes

Primary Outcome Measures

Name	Time	Method
Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group	through study completion, over one year	The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation.; Clinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients.
Percentage of occurrence of anemia and thrombocytopenia	through study completion, over one year	The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups.; Anemia is defined as decrease in hemoglobin level \<10 g/dl and Thrombocytopenia is defined as decrese in platelets count \<100 × 103/mm3

Trial Locations

Locations (1)

Beni-suef University; 🇪🇬 Banī Suwayf, Egypt