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

Primary Purpose

Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Continuous infusion Linezolid
intermittent dosing linezolid
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring linezolid continuous infusion, pneumonia, critically ill patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beni-suef UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous infusion

Intermittent dosing

Arm 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)

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
September 10, 2021
Sponsor
October 6 University
Collaborators
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04531332
Brief Title
Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia
Official Title
Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
linezolid continuous infusion, pneumonia, critically ill patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous infusion
Arm Type
Experimental
Arm 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)
Arm Title
Intermittent dosing
Arm Type
Active Comparator
Arm Description
Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes
Intervention Type
Drug
Intervention Name(s)
Continuous infusion Linezolid
Other Intervention Name(s)
intervention
Intervention Description
Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )
Intervention Type
Drug
Intervention Name(s)
intermittent dosing linezolid
Other Intervention Name(s)
control
Intervention Description
Linezolid 600 mg intravenous twice daily
Primary Outcome Measure Information:
Title
Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group
Description
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.
Time Frame
through study completion, over one year
Title
Percentage of occurrence of anemia and thrombocytopenia
Description
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
Time Frame
through study completion, over one year

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Adult, Older Adult
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed E Abou warda, BSc
Phone
00201007647696
Email
ahmed.essam@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rania M Sarhan, PhD
Phone
0021008789509
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Essam, BSc
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-suef University
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed E Abou Warda, BSc
Phone
00201007647696
Email
ahmed.essam@o6u.edu.eg
First Name & Middle Initial & Last Name & Degree
Rania M Soliman, Ph.D
First Name & Middle Initial & Last Name & Degree
Ayman N Moharram, MD
First Name & Middle Initial & Last Name & Degree
Heba Farouk, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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