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New treatment option for Hospital-acquired Bacterial Pneumonia (HABP)
Official title A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
ClinicalTrials.gov ID: NCT06841731
What this study is testing
What is HRS-8427?
HRS-8427 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hospital-acquired bacterial pneumonia (habp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- All people must have a chest radiograph during screening or within 48h before randomization, showing the presence of new or progressive infiltrate(s)...
- Women of childbearing potential must have a negative serum pregnancy test before the first dose and must be non-lactating. Fertile female people or...
You likely can't join if
- people who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
- people who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
- HABP or VABP caused by obstruction.
- people who have received potentially effective antibiotic therapy for a continuous duration of more than 24 hours during the previous 72 hours prior...
- Impairment of renal function with estimated glomerular filtration rate \< 15 mL/min, or receiving peritoneal dialysis/hemodialysis.
- people with significant laboratory abnormalities.
See the full eligibility 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 people 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 people or male people whose partner is a fertile female agree to use highly...
- people who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.
- people who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.
- HABP or VABP caused by obstruction.
- people 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.
- people with significant laboratory abnormalities.
- Other pulmonary diseases that may confound the assessment of how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.