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

ConditionsHospital-acquired Bacterial Pneumonia (HABP)Ventilator-associated Bacterial Pneumonia (VABP)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • YK-1169

    Drug

    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.

  • Ceftazidime-avibactam Injection

    Drug

    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.

Treatment groups

590 Participants
are divided into 2 treatment groups
Group A: YK-1169Experimental treatment 1 intervention
Group B: Ceftazidime-avibactam InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with all-cause mortality in the mITT population at Day 28

Time frame
Day 28

Secondary outcomes

1

Number of patients with all-cause mortality on Day 14

Time frame
Day 14

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Yoko Biomedical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: