Actively Recruiting
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-04-22
100
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
CONDITIONS
Official Title
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and complete the study
- Male or female aged 18 years or older
- Clinically diagnosed with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) requiring hospitalization and initial intravenous antibiotic treatment
- Chest radiograph within 48 hours before randomization showing new or progressive infiltrate(s) indicating bacterial pneumonia
- Women of childbearing potential must have a negative pregnancy test, be non-lactating, and agree to use highly effective contraception during the study and 14 days after treatment
- Male subjects with fertile female partners must agree to use highly effective contraception during the same period
You will not qualify if you...
- Known or suspected community-acquired bacterial pneumonia, atypical pneumonia, or chemical pneumonia
- Known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi, or parasites
- Hospital-acquired or ventilator-associated bacterial pneumonia caused by obstruction
- Received potentially effective antibiotic therapy continuously for more than 24 hours within 72 hours before randomization
- Renal impairment with estimated glomerular filtration rate less than 15 mL/min or receiving dialysis
- Significant laboratory abnormalities
- Other pulmonary diseases that may affect assessment of efficacy or safety
- History of immune deficiency disease or receiving immunocompromising treatment
- Severe and unstable cardiovascular or cerebrovascular diseases
- Known or suspected central nervous system infections
- Received cancer treatment within 4 weeks before randomization or planned treatment during the study
- Drug abuse within 1 year prior to randomization
- Other reasons judged by the investigator as unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
X
Xiaopeng Wang
CONTACT
Y
Yaru Wei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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