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

Официальное название

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)

Обзор

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

Вмешательства

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

Первичные конечные точки

• The all-cause mortality rate at Day 14. [Срок оценки: From the first dose of the study drug to Day 14.]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT06841731 · HRS-8427-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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