Trials / Terminated
TerminatedNCT05225558
A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
A Multicenter, Double-blinded, Randomized, Parallel Design, Phase IIa Clinical Trial to Evaluate the Efficacy, Safety and PK of LCB01-0371 With Vancomycin Versus Vancomycin Monotherapy in Patients With MRSA Bacteremia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- LigaChem Biosciences, Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Delpazolid | BID, PO |
| DRUG | Vancomycin | IV infusion per 2020 IDSA guideline |
| DRUG | Placebo of Delpazolid | BID, PO |
Timeline
- Start date
- 2022-04-26
- Primary completion
- 2024-02-21
- Completion
- 2024-03-18
- First posted
- 2022-02-04
- Last updated
- 2025-05-06
- Results posted
- 2025-05-06
Locations
6 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05225558. Inclusion in this directory is not an endorsement.