[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ventilator-associated-bacterial-pneumonia-vabp\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ventilator-associated-bacterial-pneumonia-vabp":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,77,107,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100643748","phase-3-a-clinical-study-of-yk-1169-versus-ceftazidime-avibactam-in-adults-with-hospital-acquired-or-ventilator-associated-bacterial-pneumonia-100643748",false,"NCT07634198","A Clinical Study of YK-1169 Versus Ceftazidime-Avibactam in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia","A Randomized, Double-Blind, Positive-Controlled, Parallel-Group, Multicenter Phase III Clinical Trial to Compare Efficacy and Safety of YK-1169 Versus Ceftazidime-Avibactam for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (HABP\u002FVABP)","Inclusion Criteria:\n\n* Obtain a signed, ethics committee-approved informed consent form prior to the start of the trial\n* Age 18 to 75 years (inclusive)\n* Study participants with HABP\u002FVABP requiring antibiotic treatment\n* Study participants who meet the following clinical, imaging, and microbiological criteria\n* Patients meeting the following clinical, imaging, and microbiological criteria: (1) Clinical criteria: Presence of at least one of the following clinical manifestations: ① New-onset or acutely worsening pulmonary symptoms or signs, such as cough, dyspnea, tachypnea (respiratory rate greater than 25 breaths per minute), sputum production, or the need for mechanical ventilation; ② Hypoxemia (arterial blood oxygen partial pressure \\\u003C60 mmHg at sea level, or a progressive decline in the oxygen partial pressure to inspired oxygen ratio (PaO₂\u002FFiO₂)); ③ Deteriorating oxygenation requiring a change in ventilatory support to improve oxygenation, or a change in the level of positive end-expiratory pressure (PEEP); ④ Newly developed respiratory secretions requiring suctioning. In addition, the patient must exhibit at least one of the following clinical signs or laboratory abnormalities: ① Documented fever (body temperature ≥38°C); ② Hypothermia (body temperature ≤35°C); ③ Total peripheral blood white blood cell count ≥10,000\u002Fmm³; ④ Total peripheral blood white blood cell count ≤ 4,500\u002Fmm³; ⑤ Peripheral blood smear showing more than 15% immature neutrophils (e.g., band cells). (2) Imaging Criteria A chest imaging study performed within 48 hours prior to randomization showing new or progressive infiltrates suggestive of bacterial pneumonia. (3) Microbiological Criteria: Sufficient, qualified sputum (defined as \\\u003C10 squamous epithelial cells and \\>25 white blood cells per low-power field in the microscopic specimen) or respiratory secretion specimens (e.g., bronchoalveolar lavage fluid) should be collected from all study participants and sent to the laboratory for Gram-stained smear microscopy, bacterial culture, and in vitro antimicrobial susceptibility testing. Pathogens isolated from bacterial cultures should be sent to a central microbiology laboratory for species identification and susceptibility testing, specifically determination of the minimum inhibitory concentration (MIC). In addition to bacterial culture, non-culture-based methods such as PCR may be used to detect bacterial and other pathogens. This will aid in the screening of HABP\u002FVABP study participants for those who are positive for bacterial and other pathogens\n* Study participants (including their partners) must have no plans to conceive between the time they sign the informed consent form and 3 months after the final administration of the study drug, must voluntarily use effective contraception, and must have no plans to donate sperm or eggs\n\nExclusion Criteria:\n\n* Study participants who received effective antibiotic therapy for more than 24 hours within 72 hours prior to randomization. (Study participants who received antibiotic therapy for more than 24 hours within 72 hours prior to randomization but for whom the treatment failed may still be eligible for enrollment); (The investigator shall confirm treatment failure based on clinically available information, such as vital signs, physical examination, laboratory tests, and\u002For imaging studies)\n* Individuals with known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents or inhalation injury)\n* Individuals with known concomitant invasive aspergillosis, mucormycosis, or other highly lethal fungal infections\n* Individuals with acute central nervous system infections\n* Individuals with cystic fibrosis\n* Patients with lung abscess\n* Patients with advanced primary or metastatic lung malignancies\n* Study participants with refractory septic shock, defined as persistent hypotension at the time of randomization despite adequate fluid resuscitation or vasopressor therapy\n* Study participants currently undergoing hemodialysis or peritoneal dialysis\n* Study participants with a history of epilepsy, or those requiring continued treatment with probenecid, valproic acid, or sodium valproate\n* Evidence of any of the following serious immune system disorders:\n\n  1. Current or anticipated neutropenia, defined as \\\u003C500 neutrophils\u002Fmm³;\n  2. Known human immunodeficiency virus (HIV) infection;\n  3. Receipt of cancer chemotherapy, radiation therapy, or potent non-hormonal immunosuppressive agents (e.g., cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapies, etc.) within the past 3 months, or use of glucocorticoids equivalent to or exceeding 40 mg of prednisone daily for more than 14 days within the past 30 days\n* Study participants with one or more of the following laboratory abnormalities in baseline specimens: estimated creatinine clearance ≤60 mL\u002Fmin calculated using the Cockcroft-Gault formula (see Appendix 3); Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin levels \\> 3 times the upper limit of normal (ULN); neutrophil count \\\u003C 0.5 × 10⁹\u002FL, platelet count \\\u003C 50 × 10⁹\u002FL\n* Acute Physiology and Chronic Health Evaluation (APACHE) II score \\> 35\n* Female study participants with a positive pregnancy test at screening or who are currently breastfeeding\n* Participants who have participated in any other clinical trial within 30 days prior to the start of this study\n* Participants who have received YK-1169 treatment prior to screening\n* Study participants with a history of allergy to cephalosporins, or a history of severe allergy to any other type of β-lactam antibiotic (e.g., penicillins, monobactams) other than cephalosporins (Note: For β-lactam antibiotics, a history of mild rash followed by uneventful re-exposure is not a contraindication for inclusion)\n* Any situation or condition deemed by the investigator to potentially jeopardize the safety of the study participant or the quality of the study data","ALL","18 Years","75 Years",{"count":20,"type":21},590,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","To evaluate the all-cause mortality rate at Day 28 in the YK-1169 group versus the ceftazidime-avibatan injection group in the mITT population.",[27,28],"Hospital-acquired Bacterial Pneumonia (HABP)","Ventilator-associated Bacterial Pneumonia (VABP)","NOT_YET_RECRUITING","2026-06-03",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":21},"2026-06-04",{"date":37,"type":21},"2028-04-01",{"name":39,"class":40},"Nanjing Yoko Biomedical Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100618047","phase-3-efficacy-and-safety-of-bv100-plus-low-dose-polymyxin-b-versus-colistin-plus-high-dose-ampicillinsulbactam-in-patients-with-hospital-acquired-or-ventilator-associated-bacterial-pneumonia-due-to-carbapenem-resistant-acinetobacter-baumannii-calcoaceticus-complex-100618047","NCT07326540","Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin\u002FSulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","A Phase 3 Prospective, Randomized, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of BV100 Plus Low-dose Polymyxin B Compared With Colistin Plus High-dose Ampicillin\u002FSulbactam in the Treatment of Adult Patients With Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","RIV-TARGET","Inclusion Criteria:\n\n1. Provide written informed consent prior to any study related procedures not part of normal medical care. If permitted by local country and institution-specific guidelines, surrogate consent\u002Fuse of a legally authorized representative may be provided. Alternatively, the decision can be made according to the procedure permitted by local law and institutional Standard Operating Procedures. If a patient regains consciousness while in the study and, per the Investigator's judgment, the patient is able to read, assess, understand, and make his\u002Fher own decision to participate in the study, the patient may agree to continue participation. In such cases, the patient must be reconsented.\n2. Male or female patients, ≥ 18 and ≤ 82 years of age at the time of signing informed consent.\n3. A confirmed diagnosis of HABP or VABP requiring treatment with IV antibiotics in the judgment of the Investigator.\n4. High probability of a pneumonia (HABP or VABP) due to ABC as a single pathogen, or member of a polymicrobial infection based on evidence from RDT from a sample collected within 48 hours prior to randomization, AND one of the following:\n\n   1. Has received no more than 48 hours of potentially active antimicrobial treatment against CRABC prior to the first dose of study drug; OR\n   2. Is clinically failing prior treatment regimens (i.e., clinical deterioration or failure to improve after at least 48 hours of antibiotic treatment).\n5. An APACHE II \\\u003C 30 or qSOFA score ≥ 2 at Screening.\n6. Women of childbearing potential must have a negative highly sensitive urine or serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use one highly effective method of contraception from Screening until at least 30 days after administration of the last dose of study drug.\n7. Diagnosed with HABP or VABP\n\nExclusion Criteria:\n\n1. For Part A only, patients with an infection known to be resistant to colistin, with a known intolerance to polymyxins, or taking any drug that prevents them from receiving polymyxins.\n2. Evidence of active concurrent pneumonia requiring additional antimicrobial treatment caused by, e.g., Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Pneumocystitis jiroveci, Aspergillus spp, respiratory syncytial virus, influenza and parainfluenza viruses, Middle East respiratory syndrome coronavirus, mycobacteria, mucormycosis.\n3. Any of the following health conditions:\n\n   1. Pulmonary disease that precludes evaluation of a therapeutic response.\n   2. Pleural empyema (exception: acceptable if drainage occurs within 24 hours of Screening and patient is expected to be treated in ≤ 14 days).\n   3. Solid organ transplant within 6 months prior to randomization.\n   4. Evidence of deep seated infection, e.g., Gram-negative osteomyelitis, or meningitis requiring prolonged therapy.\n   5. Acute infective endocarditis due to Gram-positive bacteria that requires urgent treatment\u002Femergent indication of surgery, or patients in whom surgery is contraindicated due to prohibitive risk for surgery due to comorbidities.\n   6. Surgical wound infections requiring further surgical management e.g., wound closure, drain removal.\n   7. Peritonitis.\n   8. Irremovable implantable device or line thought to be the source of the ABC infection.\n   9. Known or suspected neuropathy or neuromuscular disease.\n   10. Human immunodeficiency virus infection.\n   11. Chronic immunosuppression due to drugs and\u002For underlying disease\n4. Bronchial obstruction or a history of post obstructive pneumonia (this does not exclude patients with pneumonia who have an underlying chronic obstructive pulmonary disease).\n5. Patients classified under futility of care, as determined by the medical team, indicating a lack of potential for benefit from intervention or patients who are permanent residents of long-term care facilities and have been assessed by the clinical team as receiving palliative or comfort-focused care.\n6. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg\n7. Diagnosis of ventilator-associated tracheobronchitis.\n8. Inability to provide proper respiratory specimens for culture.\n9. Received more than 48 hours of potentially active treatment against CRABC prior to the first dose of study drug.\n10. Known or suspected allergy to polymyxin, rifabutin, colistin, ampicillin\u002Fsulbactam, meropenem or their excipients.\n11. Acute graft-versus-host disease (Grade ≥ 3).\n12. Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.\n13. Requirement at the time of randomization for any reason, or likely to require during the patient's participation in the study (from randomization through the EoS Visit), for additional systemic Gram-negative antimicrobial therapy potentially active toward CRABC.\n14. Expected survival \\\u003C 72 hours or a Do Not Resuscitate Order.\n15. Burns \\> 40% of total body surface area.\n16. Presence of neutropenia (absolute neutrophil count \\\u003C 1500\u002Fmm3) obtained from a local laboratory at Screening, or anticipated neutropenia with absolute neutrophil count \\\u003C 1500 cells\u002Fmm3.\n17. Severe renal disease defined as an estimated glomerular filtration rate (eGFR) as per Modification of Diet in Renal Disease (MDRD) formula (MDRD eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2, or requirement for peritoneal dialysis, hemodialysis, hemofiltration, or a urine output \\\u003C 20 mL\u002Fhour over a 24 hour period.\n18. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3× upper limit of normal (ULN) AND total bilirubin \\> 2×ULN at Screening (using local laboratory values); or Child Pugh Class C in patients with chronic liver function impairment. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis, hepatic cirrhosis, hepatic failure, chronic ascites, or hepatic encephalopathy.\n\n    Note: Patients with AST or ALT up to 5×ULN are eligible if these elevations are acute and are documented as being directly related to the infectious process being treated.\n19. Investigator's opinion of clinically significant ECG finding such as new ischemic changes, infarct, or ventricular arrhythmia with immediate potential for a fatal outcome, bradycardia not corrected by pacemaker or medication, or, prior to the current infection, a history of New York Heart Association Class IV cardiac failure defined as severe limitations - experiences symptoms even while at rest, mostly bedbound patients, within 1 year.\n20. Abnormal QT interval corrected for heart rate by Fridericia formula (QTcF): \\> 500 ms confirmed with repeat ECG.\n21. Stroke (ischemic or intracerebral hemorrhage) within 10 days prior to randomization or expected survival from stroke \\\u003C 28 days or Glasgow Coma Scale score 3 with no hope of improvement.\n22. Women who are pregnant or nursing.\n23. Patients who are currently enrolled in or have not yet completed, in the last 30 days or 5 half lives, whichever is longer, another investigational device or drug study or those who are receiving other investigational agents.\n24. Unable or not willing, in the opinion of the Investigator, to comply with all study protocol.","82 Years",{"count":51,"type":21},248,[24],"This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC).\n\nPart B is the single-group portion of the study and includes patients with HABP or VABP with CRABC infections that are resistant to or have failed colistin\u002Fpolymyxin B treatment.",[55,56,57,58],"Hospital Acquired Bacterial Pneumonia (HABP)","Ventilator Associated Bacterial Pneumonia (VABP)","Colistin Resistanrt ABC","Acinetobacter Baumannii-calcoaceticus Complex",[60,61,62,63,64,65],"BV100","CRABC","VABP","HABP","polymyxin B","colistin","RECRUITING","2026-04-28",{"date":69,"type":33},"2026-05-04",{"date":71,"type":33},"2026-03-27",{"date":73,"type":21},"2028-03-30",{"name":75,"class":40},"BioVersys SAS",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100626105","phase-2-safety-pharmacokinetics-and-efficacy-of-bv100-plus-low-dose-polymyxin-b-plus-ceftazidimeavibactam-or-plus-cefiderocol-in-patients-with-pulmonary-and-extrapulmonary-infections-due-to-carbapenem-resistant-acinetobacter-baumannii-calcoaceticus-complex-100626105","NCT07431307","Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime\u002FAvibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime\u002FAvibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc","RIV- CARE","Inclusion Criteria:\n\n1. Provide written informed consent prior to any study-related procedures not part of normal medical care. Surrogate consent\u002Fuse of a legally authorized representative may be provided if permitted by local country and institution-specific guidelines\n2. Male subjects or female subjects ≥ 18 and ≤ 82 years of age at the time of signing informed consent.\n3. A known or highly suspected infection caused by CRABC (VABP, HABP, or BSI of non-urinary tract origin) as either a single pathogen or member of a polymicrobial infection\n4. Diagnosed with HABP, VABP or BSI\n5. Acute Physiology and Chronic Health Evaluation (APACHE II) score ≤ 30, within 24 hours prior to randomization.\n\n   Part B specific inclusion criteria\n6. Confirmed CRABC ventriculitis or meningitis based on evidence from CSF culture collected within 72 hours prior to enrollment (as per standard of care).\n7. Functioning EVD that can be used for safe and timely CSF sampling.\n8. No contraindications to CSF sampling via EVD in the volumes required by the protocol\n\nMain Exclusion Criteria:\n\n1\\. Urinary tract infection as source of A. baumannii BSI2. Known or suspected community acquired bacterial pneumonia or viral (including SARS-CoV-2), pneumonia within the last 7 days 3. Known or suspected viral pneumonia within the last 7 days before screening e.g. positive for SARS-CoV-2 or influenza.\n\n4\\. Known fungal or parasitic pneumonia. 5. Patients classified under futility of care, as determined by the medical team, indicating a lack of potential for benefit from intervention or patients who are permanent residents of long-term care facilities and have been assessed as receiving palliative or comfort-focused care.\n\n6\\. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg (calculate mean arterial pressure = diastolic pressure plus 1\u002F3 (systolic pressure minus diastolic pressure)) with patients requiring escalating vasopressor support to maintain adequate arterial pressure in conjunction with rising lactate.7. Known or suspected allergies to polymyxins, rifabutin, ceftazidime\u002Favibactam, cefiderocol, or their excipients.\n\n8\\. Inability to insert a central catheter or a peripherally inserted central catheter (PICC).11. Acute graft versus host disease Grade ≥ 3.\n\n12\\. Expected survival \\\u003C 72 hours or a Do Not Resuscitate Order. 13. Burns \\> 40% of total body surface area. 14. Presence of neutropenia (absolute neutrophil count \\\u003C 1500\u002Fmm3) obtained from a local laboratory at Screening, or anticipated neutropenia with absolute neutrophil count \\\u003C 1500 cells\u002Fmm3.\n\n15\\. Severe renal disease defined as an estimated glomerular filtration rate (eGFR) as per Modification of Diet in Renal Disease (MDRD) formula (MDRD eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2, or requirement for peritoneal dialysis, hemodialysis, hemofiltration, or a urine output \\\u003C 20 mL\u002Fhour over a 24 hour period.",{"count":86,"type":21},120,[88],"PHASE2","This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime\u002Favibactam or cefiderocol in patients with suspected or confirmed CRABC infections. The study is divided into two parts (Part A and Part B), recruiting in parallel. Approximately 10 subjects will be recruited in Part B, with enrollment ending once Part A enrollment is complete (at least 30 patients randomized to all of the three groups). Eligible patients, who have given informed consent, will be enrolled, and pre-treatment microbiology samples submitted to a local laboratory.",[56,55,91,92,93],"Blood Stream Infection","Meningitis, Bacterial","Ventriculitis, Infectious",[62,60,63,95,96,97],"BSI","CNS infection","BioVersys","2026-02-23",{"date":100,"type":33},"2026-02-24",{"date":102,"type":21},"2026-07",{"date":104,"type":21},"2028-07",{"name":106,"class":40},"BioVersys AG",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":76},"100599799","phase-3-study-to-assess-the-efficacy-and-safety-of-meropenem-and-pralurbactam-in-carbapenem-resistant-enterobacteriaceae-infections-100599799","NCT07089186","Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections","A Phase 3, Multicenter, Randomized, Open-label, Active-controlled, Parallel-design Clinical Study to Evaluate the Efficacy and Safety of Meropenem and Pralubactam for Injection in the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections","Inclusion Criteria:\n\n* Hospitalized male or female≥18 and ≤80 years of age，\n* Participant must have a diagnosis of an infection (HABP\u002FVABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy\n* Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy\n* The estimated survival time is more than 28 days\n* Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form\n\nExclusion Criteria:\n\n* Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)\n* Participant is expected to require more than 21 days of treatment\n* Acute Physiology and Chronic Health Evaluation (APACHE) II score \\>30 using the most recent available data\n* Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices","80 Years",{"count":116,"type":21},80,[24],"The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).",[27,28,120,121,122],"Complicated Intra-abdominal Infection (cIAI)","Complicated Urinary Tract Infection (cUTI)","Bloodstream Infection (BSI)","2025-07-27",{"date":125,"type":33},"2025-07-30",{"date":127,"type":33},"2025-04-12",{"date":129,"type":21},"2027-04",{"name":131,"class":40},"Qilu Pharmaceutical Co., Ltd.",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":76},"100580778","phase-2-a-trial-of-hrs-8427-in-the-treatment-of-adults-with-bacterial-pneumonia-100580778","NCT06841731","A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia","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)","Inclusion Criteria:\n\n1. 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.\n2. Male and female, ≥18 years.\n3. Judged by the investigator, clinical diagnosis with HABP\u002FVABP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics.\n4. 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.\n5. 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\u002Fovum donation from the time of signing the informed consent form (ICF) till 14 days after the end of treatment.\n\nExclusion Criteria:\n\n1. Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, or chemical pneumonia.\n2. Subjects who have known or suspected pneumonia caused by mycoplasma, chlamydia, legionella, viruses, fungi or parasites.\n3. HABP or VABP caused by obstruction.\n4. 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.\n5. Impairment of renal function with estimated glomerular filtration rate \\\u003C 15 mL\u002Fmin, or receiving peritoneal dialysis\u002Fhemodialysis.\n6. Subjects with significant laboratory abnormalities.\n7. Other pulmonary diseases that may confound the assessment of efficacy or safety.\n8. Known history of immune deficiency disease or receive immunocompromising treatment.\n9. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled condition.\n10. Known or suspected central nervous system infections.\n11. Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period.\n12. Drug abuse within 1 year prior to randomization.\n13. Judged by the Investigator, other reasons unsuitable for this study.",{"count":140,"type":21},100,[88],"The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP\u002FVABP.",[27,28],"2025-04-21",{"date":146,"type":33},"2025-04-22",{"date":148,"type":33},"2025-04-03",{"date":150,"type":21},"2026-02",{"name":152,"class":40},"Jiangsu HengRui Medicine Co., Ltd."]