[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intra-abdominal-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intra-abdominal-infections":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,91,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100637870","diagnosis-of-abdominal-pain-using-rna-levels-the-natural-study-100637870",false,"NCT07579312","Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study","Neutrophil Activation Test Using RNA Levels to Assist in the Diagnosis of Abdominal Pain: The NATURAL Study","NATURAL","Inclusion Criteria:\n\nAge \\> 7 yr old Abdominal pain of likely non-traumatic origin Risk of intra-abdominal infection (see IAI signs) Ability to provide informed consent\u002Fassent Potential to order abdominal CT, ultrasound, endoscopy, or surgery for possible IAI\n\nExclusion Criteria:\n\nAny situation where delay could be detrimental Hemodynamically unstable (see age-adjusted criteria) Prisoner or other involuntary detainee Inability to provide informed consent\u002Fassent",true,"ALL","7 Years",{"count":21,"type":22},1000,"ESTIMATED","OBSERVATIONAL","The NATURAL Study is a prospective, observational, pragmatic study of RNA biomarkers of infections to aid in the diagnosis of abdominal pain.\n\nSummary of Research Study:\n\nHypothesis: A genomic-derived panel of 6 RNA biomarkers present in stabilized whole blood will provide diagnostic information about the presence of bacterial, biofilm, and viral infections in the abdomen. We hypothesize that biomarkers will be more than 90% sensitive with a high (\\>90%) negative predictive value for IAI.\n\nResearch Design: The project design is a prospective, pragmatic, observational study. The NATURAL Study will be sponsored by True Bearing Diagnostics, Inc., and performed at 5 or more academic medical centers. Patients with suspected intra-abdominal infections (IAIs), such as appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess are candidates for this study. This is a broad category of patients that are defined by the suspicion of an internal abdominal infection, usually involving some type of advanced imaging analysis, such as CT scan or ultrasound. All participants will be consented for this observational, minimal-risk study prior to venipuncture. Ultimately, The NATURAL Study will determine the positive agreement (\\~sensitivity) and negative agreement (\\~specificity) of the TruNAV RNA biomarkers in relation to the clinical diagnosis of the presence or absence of an IAI, based on CT scans and\u002For surgical confirmation, the current standard of care for diagnosis of IAI.\n\nObjective: To validate a novel RNA fingerprint in ED patients with suspected IAIs.\n\nThe NATURAL Study is designed to determine the accuracy of novel RNA biomarkers for diagnosis of IAI in patients suspected of having IAI. Subgroup analysis will analyse RNA biomarker for multiple types of actual and suspected IAIs (appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess.)\n\nSubjects: Approximately 1,000 ED patients presenting with abdominal pain that are candidates to receive CT or other confirmatory diagnostics will be enrolled.",[26,27,28,29,30],"Intra Abdominal Infections","Appendicitis Acute","Pyelonephritis","Diverticulitis","Epiploic Appendagitis",[26,32,33,28,29,34,35],"Biomarkers","Appendicitis","Epiploic appendagitis","Gastroenteritis","RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-12","ACTUAL",{"date":42,"type":40},"2026-04-17",{"date":44,"type":22},"2027-09",{"name":46,"class":47},"True Bearing Diagnostics, Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100606199","phase-4-gelaspan-vs-crystalloid-therapy-in-sepsis-100606199","NCT07172451","Gelaspan vs Crystalloid Therapy in Sepsis","Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial","SPACES","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source control.\n* Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \\> 2 mmol\u002FL (measured within 6 hours prior to enrollment).\n* Subject or legal representative can understand the study purpose and provide written informed consent.\n\nExclusion Criteria:\n\n* Received any dose of artificial colloids within 24 hours prior to randomization.\n* Predicted mortality within 48 hours (ASA physical status class ≥ V).\n* Atrial fibrillation or congestive heart failure.\n* Severe Acute Respiratory Distress Syndrome (ARDS).\n* Preoperative coagulation dysfunction or receiving anticoagulant therapy.\n* Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis).\n* Acute burns exceeding 10% of the total body surface area.\n* Severe hepatic impairment.\n* Severe electrolyte disturbance.\n* Pregnancy or breastfeeding.\n* Known allergy to gelatin.\n* Current participation in other interventional clinical trials.\n* Other conditions that the investigator considers inappropriate for inclusion.","18 Years",{"count":59,"type":22},318,"INTERVENTIONAL",[62],"PHASE4","The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone.\n\nIn this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are:\n\n* Does balanced gelatin reduce positive fluid balance within 24 hours after surgery?\n* Does it improve hemodynamic stability during the early postoperative period?\n* What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes?\n\nParticipants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study.\n\nThe findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.",[65,66],"Sepsis","Intra-Abdominal Infections",[68,69,70,71,72,73,74,75,76,77,78,79],"Balanced gelatin solution","Succinylated gelatin","Crystalloid","Ringer's acetate","Fluid resuscitation","Goal-directed fluid therapy","Emergency abdominal surgery","Microcirculation","Hemodynamic stabilization","SOFA score","Lactate clearance","Randomized controlled trial","2026-03-17",{"date":82,"type":40},"2026-03-20",{"date":84,"type":40},"2026-02-13",{"date":86,"type":22},"2028-12-30",{"name":88,"class":89},"Shanghai Zhongshan Hospital","OTHER",9,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":17,"sex":18,"minAge":57,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":60,"phases":101,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":48},"100608879","phase-1-phase-i-study-of-singlemultiple-ascending-doses-of-jkn2501-for-injection-in-chinese-healthy-volunteers-100608879","NCT07207291","Phase I Study of Single\u002FMultiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers","A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers","Inclusion Criteria:\n\n* Voluntary informed consent; able to comply with study requirements and communicate effectively.\n* Healthy subjects aged 18-45 years (inclusive) at screening.\n* BMI 19.0-26.0 kg\u002Fm² (inclusive); weight ≥50 kg (male) or ≥45 kg (female).\n* Vital signs, physical examination, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant by the investigator.\n* Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm\u002Fegg donation plans during this period.\n\nExclusion Criteria:\n\n* Pregnant\u002Flactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.\n* Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.\n* Use of drugs known to inhibit\u002Finduce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior to dosing; planned use during the trial.\n* Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.\n* History of febrile illness or active infection within 2 weeks prior to screening.\n* Blood loss\u002Fdonation \\>400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days after last dose.\n* History of significant food\u002Fdrug allergy, or allergy to JKN2501\u002Fexcipients.\n* Excessive alcohol consumption; inability to abstain from alcohol from 48h pre-dose until end of study.\n* Smoking ≥5 cigarettes\u002Fday within 3 months prior to screening; inability to abstain from smoking from 48h pre-dose until end of study.\n* History of drug abuse; positive urine drug screen at baseline (Day -1).\n* Positive alcohol breath test at baseline (Day -1).\n* Participation in another interventional clinical trial within 3 months prior to screening or planned during this trial.\n* Estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin.\n* Serum total calcium below lower limit of normal at screening.\n* Investigator-determined unsuitable venous access for PK sampling\u002Finfusion, or history of adverse symptoms\u002Fphobias related to infusion\u002Fphlebotomy.\n* Excessive daily intake of tea, coffee, or caffeinated beverages within 3 months prior to screening.\n* Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods\u002Fbeverages within 48h prior to first dose; inability to abstain during the trial.\n* History of QTc prolongation; or investigator-determined clinically significant ECG abnormalities at screening\u002Fbaseline.\n* Any other condition deemed by the investigator to make the subject unsuitable for participation.","45 Years",{"count":100,"type":22},66,[102],"PHASE1","This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts:\n\nPart 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis.\n\nPart 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults.\n\nDose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.",[105,106,66,107],"Bacterial Infections","Urinary Tract Infections","Respiratory Tract Infections",[105],"2025-09-28",{"date":111,"type":40},"2025-10-03",{"date":113,"type":40},"2025-08-22",{"date":115,"type":22},"2026-03-19",{"name":117,"class":47},"Joincare Pharmaceutical Group Industry Co., Ltd",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":60,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":48},"100564787","phase-3-study-to-assess-the-efficacy-and-safety-of-meropenem-and-pralurbactam-in-ciai-100564787","NCT06633718","Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI","A Phase 3,Multicenter, Randomized, Double-Blind, Positive Control，Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Complicated Intra-abdominal Infections","Inclusion Criteria:\n\n* Male or female participants ≥18 and ≤75 years of age.\n* Diagnosed or highly suspected cIAI.\n* Evidence of a systemic inflammatory response with at least one of the following:a. Fever ( temperature ≥ 38°C); b. hypotension (systolic blood pressure \\\u003C 90 mmhg); c. abdominal pain; d. nausea and\u002For vomiting; e. physical examination found abdominal mass; f. mental state change; g. other circumstances.\n* Female subjects must meet the following conditions: a. menopause for at least 1 year, or b. Sterilization has been performed, or C. Those who are fertile must meet the following conditions at the same time: the random pre-blood\u002Furine pregnancy test is negative, effective contraceptive measures are taken during the study period and within 30 days after the last application of experimental drugs, and eggs are not donated, and they are not breastfeeding.\n* Male subjects are willing to take effective contraceptive measures and not donate sperm during the study period and within 30 days after the last application of experimental drugs.\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* Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.\n* Non-complicated abdominal infection (infection is limited to abdominal organs), such as simple appendicitis and simple cholecystitis.\n* Abdominal wall infection or abscess (infection has not spread into abdominal cavity).\n* The creatinine clearance rate in the screening period is ≤50mL\u002Fmin.\n* The estimated survival time is less than 4 weeks.\n* Those who have a history of drug abuse or drug abuse within 6 months before screening.\n* Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.\n* Any physiological or psychological disease or condition that may increase the risk of the experiment, affect the compliance of the subject with the protocol or affect the completion of the experiment as judged by the researcher.\n* Subjects are directly related persons who participated in this research.","75 Years",{"count":127,"type":22},786,[129],"PHASE3","This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).",[132],"Intra-abdominal Infections","NOT_YET_RECRUITING","2024-10-07",{"date":136,"type":40},"2024-10-09",{"date":138,"type":22},"2024-10-31",{"date":140,"type":22},"2027-05-30",{"name":142,"class":47},"Qilu Pharmaceutical Co., Ltd."]