A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With M… (NCT05225558) | Clinical Trial Compass
TerminatedPhase 2
A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
Stopped: Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia
South Korea40 participantsStarted 2022-04-26
Plain-language summary
The objectives of this study is to exploratory whether Vancomycin + Delpazolid is more effective to the standard of treatment (Vancomycin)/ for hospitalized adults with MRSA bacteraemia.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female ≥19 years of age on the date of written consent
* Subject who has confirmed positive MRSA at least one set of blood cultures within 72 hours prior to randomization OR, Subject who has confirmed positive MRSA at least one set of blood culture whthin 96 hours prior to randomization and treated with vancomycin at least 72 hours prior to randomization
* Subject who has clinical symptoms or signs of MRSA bacteremia according to the judgment of the investigator
* Subject who voluntarily decides to participate in this clinical trial after being explained fully, and agrees in writing to implement the clinical trial compliance matters
Exclusion Criteria:
* Subject with polymicrobial bacteremia or infections including Gram-negative strain
* Subject undergoing or in need of treatment with antiviral or antifungal drugs
* Subject who has received treatment for MRSA bacteremia within 3 months of screening (Subjects who have "re-infection" by investigator's judgement may participant in the study.)
* Subject who has been administered effective antibiotics against MRSA (Vancomycin, etc.) for more than 96 hours prior to the first investigational product administration. (However, antibiotics effective for MRSA such as vancomycin are allowed to be administered for less than 72 hours.)
* Septic shock patients
* Subject who has hypersensitivity to vancomycin or linezolid
* Subject who has a history of hypersensitivity to peptide-based antibiotics and aminogl…
What they're measuring
1
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS
Timeframe: at Day 14
2
Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_PPS