[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complicated-intra-abdominal-infection-ciai\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complicated-intra-abdominal-infection-ciai":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100644724","ulinastatin-on-systemic-immune-inflammation-in-patients-with-complicated-intra-abdominal-infection-100644724",false,"NCT07672496","Ulinastatin on Systemic Immune-Inflammation in Patients With Complicated Intra-Abdominal Infection","A Single-Center Randomized Controlled Pilot Study on the Effect of Ulinastatin on Systemic Immune and Inflammatory Response in Patients With Complicated Intra-Abdominal Infection","UTI-cIAI","Inclusion Criteria:\n\n1. Able to provide written informed consent voluntarily.\n2. Age ≥ 18 years old, any gender.\n3. Diagnosed with severe complicated intra-abdominal infection (cIAI) within 48 hours, consistent with the 2025 expert consensus for cIAI diagnosis. Diagnosis is confirmed by clinical symptoms (fever, abdominal pain, distension, etc.), abdominal imaging (CT\u002Fultrasound\u002FMRI), intraoperative findings, or positive pathogen culture of abdominal drainage fluid.\n4. Baseline Sequential Organ Failure Assessment (SOFA) score ≥ 2 points.\n\nExclusion Criteria:\n\n1. Severe immune deficiency conditions, including AIDS, prior solid organ or bone marrow transplantation, HIV infection with CD4 count \\\u003C 200 cells\u002Fmm³, long-term high-dose glucocorticoid therapy (prednisone \\> 20 mg\u002Fday), ongoing chemotherapy for malignant tumors, or absolute neutrophil count \\\u003C 1000 cells\u002Fmm³.\n2. Severe irreversible underlying diseases, including chronic renal failure requiring dialysis, Child-Pugh grade C liver disease, liver disease with severe portal hypertension, or acute liver failure.\n3. Patients with active malignant tumors, pregnancy, or severe psychiatric disorders.\n4. American Society of Anesthesiologists (ASA) physical status grade IV or above.\n5. Severe coagulation disorder defined as ISTH-DIC score ≥ 5 points.\n6. Critically ill patients with expected death within 48 hours after admission.\n7. Known allergy to ulinastatin or any ingredients of the study preparation.\n8. Any condition that, in the judgment of the principal investigator, makes the patient inappropriate for trial participation.","ALL","18 Years",{"count":20,"type":21},165,"ESTIMATED","INTERVENTIONAL",[24],"NA","Complicated intra-abdominal infection (cIAI) triggers dysregulated systemic inflammation and immune paralysis leading to high organ failure and death risk. Ulinastatin is a protease inhibitor with anti-inflammatory properties, but its dose-related effects on immune-inflammation of cIAI patients remain unclear. This single-center single-blinded three-arm randomized controlled pilot study enrolls adult cIAI patients (≥18 years, SOFA≥2) at Fujian Medical University Union Hospital. Eligible patients are randomized into low-dose ulinastatin, high-dose ulinastatin and normal saline placebo groups (1:1:1, 5 days intravenous treatment plus standard care), total planned enrollment 165 participants after 10% dropout adjustment. Primary endpoint is Day5 change of Systemic Immune-Inflammation Index (SII); secondary outcomes include serial inflammatory biomarkers, SOFA variation, organ dysfunction, hospitalization duration, 28-day mortality and safety profiles. This pilot aims to clarify ulinastatin's immune-modulating effect and inform future large RCT design.",[27,28,29,30],"Complicated Intra-abdominal Infection (cIAI)","Systemic Inflammatory Response","Sepsis","Immune Dysfunction",[32,33,34,35,36],"immune dysfunction","Complicated intra-abdominal infection","Ulinastatin","SII","inflammation","NOT_YET_RECRUITING","2026-06-26",{"date":40,"type":41},"2026-06-29","ACTUAL",{"date":43,"type":21},"2026-10-30",{"date":45,"type":21},"2028-06-30",{"name":47,"class":48},"Fujian Medical University Union Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"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":59,"type":21},80,[61],"PHASE3","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).",[64,65,27,66,67],"Hospital-acquired Bacterial Pneumonia (HABP)","Ventilator-associated Bacterial Pneumonia (VABP)","Complicated Urinary Tract Infection (cUTI)","Bloodstream Infection (BSI)","RECRUITING","2025-07-27",{"date":71,"type":41},"2025-07-30",{"date":73,"type":41},"2025-04-12",{"date":75,"type":21},"2027-04",{"name":77,"class":78},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY"]