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

Last updated: September 10, 2021
Sponsor: October 6 University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT04531332
REC-H-PhBSU-20004
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Age <18 years, Pregnancy, Lactation
  • Previous known allergic reaction to linezolid
  • Creatinine Clearance (CrCl) <10 mL/min, calculated according to the Cockcroft-Gaultformula
  • 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

Total Participants: 169
Study Start date:
November 15, 2019
Estimated Completion Date:
September 15, 2021

Study 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.

Connect with a study center

  • Beni-suef University

    Banī Suwayf,
    Egypt

    Active - Recruiting

  • Beni-suef University

    Beni-suef,
    Egypt

    Site Not Available

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