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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531332
• Other study ID #: REC-H-PhBSU-20004
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: September 2021
• Source: October 6 University
• Contact: Ahmed E Abou warda, BSc
• Phone: 00201007647696
• Email: ahmed.essam[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 169
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Continuous infusion Linezolid
Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )
• intermittent dosing linezolid
Linezolid 600 mg intravenous twice daily

Locations

Country	Name	City	State
Egypt	Beni-suef University	Bani Suwayf

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group	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.	through study completion, over one year
Primary	Percentage of occurrence of anemia and thrombocytopenia	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	through study completion, over one year