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Recruiting NCT06841731

A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia

Phase II Interventional Hospital-acquired Bacterial Pneumonia (HABP) Ventilator-associated Bacterial Pneumonia (VABP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-8427, Meropenem.
Who it may be relevant to
Registry conditions: Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of HRS-8427 in the Treatment of Adults With Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP)

Overview

The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.

Interventions

  • Drug HRS-8427
    HRS-8427 for injection.
  • Drug Meropenem
    Meropenem for injection.

Primary outcome measures

  • The all-cause mortality rate at Day 14. [Time frame: From the first dose of the study drug to Day 14.]
Secondary outcome measures (7)
  • The all-cause mortality rate at Day 28. [Time frame: From the first dose of the study drug to Day 28.]
  • The total ventilation time. [Time frame: Day 14 to Day 21.]
  • The total ventilation time. [Time frame: Day 21 to Day 28.]
  • The percentage of participants with microbiologic eradication at the early assessment (EA) period. [Time frame: Day 4 after the start of the treatment.]
  • The percentage of participants with microbiologic eradication at the end of treatment (EOT) period. [Time frame: Day 7 to 14.]
  • The percentage of participants with microbiologic eradication at the test of cure (TOC) period. [Time frame: Day 14 to 21.]
  • The percentage of participants with microbiologic eradication at the follow-up (FU) period. [Time frame: Day 21 to 28.]

Eligibility criteria

Inclusion criteria

  • Be able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol.
  • Male and female, ≥18 years.
  • Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.
  • All subjects must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia.
  • Women of childbearing potential must have a negative serum pregnancy test before the first dose and must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth and sperm/ovum donation from the time of signing the informed consent form (ICF) till 14 days after the end of treatment.

Exclusion criteria

  • Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
  • Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
  • HABP or VABP caused by obstruction.
  • Subjects who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization.
  • Impairment of renal function with estimated glomerular filtration rate < 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
  • Subjects with significant laboratory abnormalities.
  • Other pulmonary diseases that may confound the assessment of efficacy or safety.
  • Known history of immune deficiency disease or receive immunocompromising treatment.
  • Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.
  • Known or suspected central nervous system infections.
  • Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.
  • Drug abuse within 1 year prior to randomization.
  • Judged by the Investigator, other reasons unsuitable for this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Publications

  • Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3. PMID 41773934
  • Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13. PMID 41528248

Identifiers

NCT: NCT06841731 · HRS-8427-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗