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

Sponsor
October 6 University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04531332
Collaborator
Beni-Suef University (Other)
169
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Continuous infusion Linezolid
  • Drug: intermittent dosing linezolid
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
169 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients
Actual Study Start Date :
Nov 15, 2019
Anticipated Primary Completion Date :
Sep 15, 2021
Anticipated Study Completion Date :
Sep 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Continuous infusion

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)

Drug: Continuous infusion Linezolid
Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )
Other Names:
  • intervention

    		•
    Active Comparator: Intermittent dosing

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

    Drug: intermittent dosing linezolid
    Linezolid 600 mg intravenous twice daily
    Other Names:
  • control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-suef University Banī Suwayf Egypt

    Sponsors and Collaborators

    • October 6 University
    • Beni-Suef University

    Investigators

    • Principal Investigator: Ahmed Essam, BSc, October 6 University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Essam, Principle Investigator, October 6 University
    ClinicalTrials.gov Identifier:
    NCT04531332
    Other Study ID Numbers:
    • REC-H-PhBSU-20004
    First Posted:
    Aug 28, 2020
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Ahmed Essam, Principle Investigator, October 6 University
    linezolid continuous infusion
    pneumonia
    critically ill patients
    Additional relevant MeSH terms:
    Pneumonia
    Linezolid

    Study Results

    No Results Posted as of Sep 16, 2021