A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia

  • STATUS
    Recruiting
  • End date
    Nov 10, 2023
  • participants needed
    100
  • sponsor
    LegoChem Biosciences, Inc
Send
Updated on 10 May 2022
See if I qualify

Summary

The objectives of this study is to exploratory whether vancomycin + delpazolid is more effective to the standard of treatment (vancomycin)/ for hospitalised adults with MRSA bacteraemia.

Description

The mortality from S aureus bacteremia is higher for MRSA than for methicillin-susceptible S aureus (MSSA), typically at 20% to 25%.

The current standard therapy for MRSA bacteremia is vancomycin. Vancomycin has many shortcomings, including poor tissue penetration and slow killing time. Vancomycin has reduced efficacy against MRSA and tended to increase the MIC level (called MIC creep). Addition of Delpazolid to Vancomycin could improve the known drawbacks of Vancomycin alone.

Details
Condition MRSA Bacteremia
Treatment Vancomycin, Delpazolid, Placebo of Delpazolid
Clinical Study IdentifierNCT05225558
SponsorLegoChem Biosciences, Inc
Last Modified on10 May 2022

Eligibility

 Yes No Not Sure

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 culture within 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
Subject who has been administered effective antibiotics against MRSA (Vancomycin, etc.) for more than 72 hours prior to the first administration of the investigational product
Septic shock patients
Subject who has hypersensitivity to Vancomycin or Linezolid
Subject who has a history of hypersensitivity to peptide-based antibiotics and aminoglycoside-based antibiotics
Subject who is receiving a MAO inhibitor(MAOI) or has received MAOI within 14 days of the first investigational drug administration
Subject taking serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptan), meperidine or buspirone
Subject with severely decreased immunity (Severe neutropenia (ANC <0.5×10^9/L) etc.)
Subject who is expected to die within 2 days due to serious complications of MRSA bacteremia based on the judgment of the investigator
Body Mass Index (BMI) ≥35 kg/m2
Subject who is unable to administer drugs orally
Pregnant or lactating female, female or male with childbearing potential who disagrees with the use of appropriate contraceptive methods during the study and up to 14 days after the last dose of the investigator product
Subject who has received other clinical trial drugs within 30 days of screening
Subject who is not suitable for participation in this clinical trial according to the medical findings of investigators
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note