A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
NCT ID: NCT06841731
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-04-03
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HRS-8427
HRS-8427
HRS-8427 for injection.
Meropenem
Meropenem
Meropenem for injection.
Interventions
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HRS-8427
HRS-8427 for injection.
Meropenem
Meropenem for injection.
Eligibility Criteria
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Inclusion Criteria
2. Male and female, ≥18 years.
3. Judged by the investigator, clinical diagnosis with HABP/VABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.
4. 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.
5. 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
2. Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
3. HABP or VABP caused by obstruction.
4. 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.
5. Impairment of renal function with estimated glomerular filtration rate \< 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
6. Subjects with significant laboratory abnormalities.
7. Other pulmonary diseases that may confound the assessment of efficacy or safety.
8. Known history of immune deficiency disease or receive immunocompromising treatment.
9. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.
10. Known or suspected central nervous system infections.
11. Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.
12. Drug abuse within 1 year prior to randomization.
13. Judged by the Investigator, other reasons unsuitable for this study.
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRS-8427-201
Identifier Type: -
Identifier Source: org_study_id
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