[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"klebsiella-pneumoniae-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:klebsiella-pneumoniae-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100053330","outer-membrane-vesicle-and-ferroptosis-related-signatures-in-sepsis-associated-acute-lung-injury-caused-by-extra-pulmonary-hypervirulent-klebsiella-pneumoniae-100053330",false,"NCT07686887","Outer Membrane Vesicle and Ferroptosis-Related Signatures in Sepsis-Associated Acute Lung Injury Caused by Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae","Circulating Bacterial Outer Membrane Vesicle Signatures and Ferroptosis-Related Biomarkers in Sepsis-Associated Acute Lung Injury Among Patients With Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae Infection: A Prospective Observational Translational Cohort Study","OMV-FERRO-ALI","Inclusion Criteria:\n\n* Age 18-85 years .\n* Clinical suspicion of infection with acute organ dysfunction consistent with suspected sepsis at the time of enrollment, as determined by the treating clinical team.\n* Presumed extra-pulmonary source of infection at enrollment, including but not limited to hepatobiliary, urinary, intra-abdominal, skin and soft-tissue, vascular catheter-related, or primary bloodstream infection.\n* Blood cultures and\u002For clinically indicated source cultures obtained or ordered as part of routine clinical care.\n* Enrollment and first research blood collection completed within 6 hours after initiation of the clinical sepsis evaluation.\n* No evidence of acute lung injury at the index time point, according to the protocol-defined criteria.\n* Written informed consent obtained from the participant or legally authorized representative, unless an ethics-approved deferred-consent procedure is used.\n\nExclusion Criteria:\n\n* Suspected or confirmed primary pulmonary infection at enrollment, including community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, or aspiration pneumonia.\n\nAcute lung injury or acute respiratory distress syndrome present at the index time point.\n\n* Acute cardiogenic pulmonary edema, acute decompensated heart failure, or another condition that would preclude reliable adjudication of subsequent non-cardiogenic acute lung injury.\n* Recent inhalation injury, near-drowning, major thoracic trauma, or transfusion-related acute lung injury.\n* Previous enrollment in this study.\n* Inability to obtain informed consent from the participant or legally authorized representative when deferred-consent procedures are not permitted by the local ethics committee.","ALL","18 Years","85 Years",{"count":21,"type":22},120,"ESTIMATED","28 Days","OBSERVATIONAL","This prospective observational translational cohort study will investigate whether extra-pulmonary infection caused by hypervirulent Klebsiella pneumoniae (hvKP) is associated with an increased risk of sepsis-associated acute lung injury (SALI), compared with infection caused by classical Klebsiella pneumoniae (cKP). The study will further examine whether circulating bacterial outer membrane vesicle (OMV) signals and ferroptosis-related biomarker profiles are associated with subsequent SALI development.\n\nAdults with Sepsis-3 and microbiologically confirmed extra-pulmonary K. pneumoniae infection will be enrolled within 6 hours of sepsis recognition. Patients with acute lung injury at enrollment will be excluded from the primary cohort. Blood samples will be collected at enrollment, 24 hours, and 72 hours. Clinical isolates will undergo molecular characterization to classify infections as hvKP or cKP. The primary outcome will be new-onset SALI within 7 days after enrollment. A nested translational substudy will evaluate the effects of patient-isolate-derived OMVs on human pulmonary microvascular endothelial cells.\n\nThe study will not alter antimicrobial therapy, source control, respiratory support, fluid management, or any other aspect of routine clinical care.",[27,28,29,30],"Sepsis","Acute Lung Injury(ALI)","Klebsiella Pneumoniae Infection","Hypervirulent Klebsiella Pneumoniae Infection",[32,33,34,35,36,37,38,39],"Hypervirulent Klebsiella pneumoniae","Extra-pulmonary infection","Sepsis-associated acute lung injury","Bacterial outer membrane vesicles","Ferroptosis","Pulmonary microvascular endothelial cells","Lipid peroxidation","Endothelial barrier dysfunction","NOT_YET_RECRUITING","2026-07-09",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":22},"2026-07-06",{"date":48,"type":22},"2030-07-30",{"name":50,"class":51},"Southeast University, China","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100614515","phase-1-safety-of-combined-intravenous-antibiotic-and-bacteriophage-therapy-in-adults-with-cystic-fibrosis-and-antibiotic-resistant-lung-infections-100614515","NCT07280598","Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections","Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed diagnosis of cystic fibrosis.\n* Sputum culture within 24 months and at screening showing at least one of the following: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.\n* Percent predicted FEV₁ ≥ 40% (GLI).\n* If ppFEV₁ \\> 40%, must have ≥ 1 pulmonary exacerbation per year requiring IV antibiotics or radiographic evidence of severe disease.\n* Prior successful home IV antibiotic therapy within 5 years (may be waived by investigator).\n* Available phage cocktail with lytic activity against the participant's pathogen.\n\nOxygen saturation \\> 88% on room air after rest. Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Untreated or uncontrolled mycobacterial or fungal airway infection.\n* History of Clostridioides difficile without a negative test within 3 months. Concerning exotoxin, virulence, or resistance genes in the bacterial isolate (per investigator).\n* Mixed-species bacterial infection at screening.\n* Participation in another interventional trial within 30 days.\n* Allergy or hypersensitivity to study materials.\n* Pregnancy, planned pregnancy, or breastfeeding.\n* Any condition or abnormality that, in the investigator's judgment, makes participation unsafe or may interfere with study assessments.",{"count":60,"type":22},30,"INTERVENTIONAL",[63],"PHASE1","This is a Phase 1, open-label, multi-center pilot study evaluating the safety and microbiological activity of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics in adults with cystic fibrosis (CF) experiencing pulmonary exacerbations due to antibiotic-resistant bacterial infections. Eligible participants will receive a 7-day course of IV antibiotics, selected by their treating clinician, along with a phage cocktail specifically formulated to target their identified bacterial pathogen (Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans). The primary objective is to assess the safety and tolerability of this combined treatment approach. Secondary and exploratory outcomes include assessment of changes in sputum bacterial burden, lung function (spirometry and oscillometry), quality of life, and bacteriophage pharmacokinetics. Results from this study will inform the feasibility and design of future clinical trials using phage therapy in the CF population.",[66,29,67,68,69,70],"CF - Cystic Fibrosis","E Coli Infections","Staphylococcus Aureus Infection","Achromobacter","Stenotrophomonas Maltophilia Infection",[72,73,74,75],"cystic fibrosis","CF","Phage","bacteriophage","2025-12-09",{"date":78,"type":44},"2025-12-12",{"date":80,"type":22},"2025-12-31",{"date":82,"type":22},"2027-01-30",{"name":84,"class":51},"University of California, San Diego",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":61,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100594185","phase-1-an-open-label-dose-finding-phase-i-study-to-evaluate-the-safety-and-immunogenicity-of-a-bivalent-klebsiella-pneumoniae-vaccine-cho-v08-in-healthy-adults-100594185","NCT07016152","An Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of a Bivalent Klebsiella Pneumoniae Vaccine (CHO-V08) in Healthy Adults","Inclusion Criteria:\n\n* Male or non-pregnant female, aged 18 to 50 years old (inclusive) for Cohorts 1 and 2 at the Screening visit.\n* Body mass index (BMI) of 18.0 to 30.0 kg\u002Fm2 (inclusive) at the Screening visit.\n* Physically and mentally capable of participating in the study and willing to adhere to study procedures.\n* Able to provide signed informed consent.\n* In generally good health by medical history, physical examination, vital signs, and clinical laboratory findings at the Screening visit based on the investigator's judgment.\n* Negative serology test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.\n* Female subject with childbearing potential must have a negative result of pregnancy test at the Screening visit.\n* Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period.\n* Male subject who agrees to use an adequate method of contraception during the study period.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of AEs.\n* Suspected or known hypersensitivity (including allergy) to any of the vaccine components.\n* History of hypersensitivity or allergy to any vaccine, especially pneumococcal vaccine.\n* Current or previous, confirmed, or suspected disease caused by Klebsiella pneumoniae.\n* Medical conditions as a contraindication to the intramuscular vaccination and blood draws, e.g., coagulation disorder.\n* Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (deltoid region).\n* Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal diseases and\u002For insufficiency as determined by physical examination or laboratory tests.\n* Known or suspected impairment of immunological function, e.g., asplenia\u002Fsplenectomy or history of autoimmune\u002Fimmune-mediated diseases or lymphoproliferative disorders.\n* Any screening laboratory abnormalities that are Grade 2 or above or deemed clinically significant in the opinion of the investigator.\n* Subjects with an electrocardiogram (ECG) at the Screening visit that demonstrates clinically relevant abnormalities which may affect subject safety or study results in the opinion of the investigator.\n* Positive test for SARS-CoV-2 virus at the Screening visit.\n* Use of any antibiotic therapy within 1 week prior to the first study vaccination.\n* History of any chronic or progressive disease that, according to judgment of the investigator, could interfere with the study outcomes or pose a threat to the subject's health.\n* History of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.\n* History or presence of heavy smoking (defined as \\> 10 cigarettes per day; approximately half pack per day) as documented in medical chart or by verbal confirmation at the Screening visit.\n* Documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months prior to the Screening visit.\n* Received any vaccination (live, inactivated, or bacterial) within 1 month prior to the Screening visit and plans to receive vaccination within 4 weeks after the last study vaccination during the study period. Exception can be made with marketed vaccines against seasonal influenza or COVID-19 outside the 28-day window of the study vaccination.\n* Received major surgery or radiation therapy within 3 months prior to the Screening visit.\n* Onset of influenza-like illness as defined by: fever (temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production, dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat within 1 week prior to the Screening visit.\n* Female subject who is pregnant or lactating at the Screening visit or plans to be pregnant during the study period or lactate from the time of the first vaccination through 60 days after the last vaccination.\n* Received any investigational drug or device or have participated in a clinical study within 3 months prior to the Screening visit.\n* Any confirmed or suspected abnormal immune function, immunosuppression, or immunodeficiency or received any immunosuppressants (including systemic corticosteroids) or immunomodulators within 3 months prior to the Screening visit.\n* Had blood donation within 2 weeks prior to the Screening visit.\n* Received any blood products or immunoglobulin within 3 months prior to the Screening visit.",true,"50 Years",{"count":94,"type":22},40,[63],"CHO-V08 is currently being developed as a prevention vaccine against nosocomial and community-acquired infection caused by hypervirulent Klebsiella pneumoniae K1 and K2 serotypes. The goal of study (KLEBBI-001) is to evaluate the safety, reactogenicity, and immunogenicity of the preventive vaccine of CHO-V08 in healthy volunteers aged from 18 to 50 years old.",[29,98],"Vaccine",[29,98],"RECRUITING","2025-06-26",{"date":103,"type":44},"2025-06-27",{"date":101,"type":44},{"date":106,"type":22},"2027-04-10",{"name":108,"class":109},"Cho Pharma Inc.","INDUSTRY",1]