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A Clinical Study of YK-1169 Versus Ceftazidime-Avibactam in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

NCT07634198 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2026-06-08

No results posted yet for this study

Summary

To evaluate the all-cause mortality rate at Day 28 in the YK-1169 group versus the ceftazidime-avibatan injection group in the mITT population.

Conditions

  • Hospital-acquired Bacterial Pneumonia (HABP)
  • Ventilator-associated Bacterial Pneumonia (VABP)

Interventions

DRUG

YK-1169

Dissolve 2.5 g of YK-1169 in 0.9% saline solution to a total volume of 100 mL, and administer by intravenous infusion at a constant rate over 120 minutes (±15 min), once every 8 hours (±30 min); the total duration of treatment is 7 to 14 days.

DRUG

Ceftazidime-avibactam Injection

Dissolve 2.5 g of ceftazidime-avibactam in 0.9% saline solution to a total volume of 100 mL, and administer by intravenous infusion at a constant rate over 120 minutes (±15 min), once every 8 hours (±30 min); the total duration of treatment is 7 to 14 days.

Sponsors & Collaborators

  • Nanjing Yoko Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-04
Primary Completion
2028-04-01
Completion
2028-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634198 on ClinicalTrials.gov