Last updated: September 10, 2021
Sponsor: October 6 University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pneumonia
Treatment
N/AClinical Study ID
NCT04531332
REC-H-PhBSU-20004
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
Beni-suef University
Banī Suwayf,
EgyptActive - Recruiting
Beni-suef University
Beni-suef,
EgyptSite Not Available
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