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

Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04531332

Enrollment

169

Registered

2020-08-28

Start date

2019-11-15

Completion date

2021-09-15

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

linezolid continuous infusion, pneumonia, critically ill patients

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.

Interventions

DRUGContinuous infusion Linezolid

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

DRUGintermittent dosing linezolid

Linezolid 600 mg intravenous twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactAhmed E Abou warda, BSc

ahmed.essam@o6u.edu.eg00201007647696

Backup ContactRania M Sarhan, PhD

0021008789509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026