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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Yoko Biomedical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Obtain a signed, ethics committee-approved informed consent form prior to the start of the trial

Age 18 to 75 years (inclusive)

Study participants with HABP/VABP requiring antibiotic treatment

Study participants who meet the following clinical, imaging, and microbiological criteria

Disqualifiers

Study participants who received effective antibiotic therapy for more than 24 hours within 72 hours prior to randomization. (Study participants who received antibiotic therapy for more than 24 hours within 72 hours prior to randomization but for whom the treatment failed may still be eligible for enrollment); (The investigator shall confirm treatment failure based on clinically available information, such as vital signs, physical examination, laboratory tests, and/or imaging studies)

Individuals with known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents or inhalation injury)

Individuals with known concomitant invasive aspergillosis, mucormycosis, or other highly lethal fungal infections

Individuals with acute central nervous system infections

Trial design

Treatments tested in this trial

  • YK-1169
  • Ceftazidime-avibactam Injection

Treatment groups

590 Participants
are divided into 2 treatment groups

Locations

This trial has no locations