[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gram-negative-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gram-negative-infections":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,79,112,140],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100630726","the-impact-of-fast-antimicrobial-sensitivity-testing-tools-on-stewardship-antibiotic-and-clinical-outcome-act-fast-100630726",false,"NCT07491419","The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)","The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome: a Randomized Clinical Trial Within an Adaptive Platform Trial for Patients With Bloodstream Infections","ACT-FAST","Inclusion Criteria:\n\n* Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected BSI and positive blood culture.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Have previously taken part in this trial.\n* Concurrently participating in the active phase of a study considered incompatible.\n* Patient with severe or terminal disease with life expectancy shorter than 48 h.\n* Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"NA","The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI). The primary objective is to evaluate whether \"early targeted\" antibiotic prescriptions, guided by these rapid tests, can improve antimicrobial stewardship and patient clinical outcomes.\n\nTo facilitate the evaluation of various diagnostic tools-including those currently on the market and those emerging in the near future-this study utilizes an adaptive clinical trial platform. This flexible design allows for the continuous assessment of different R-AST technologies within a single master protocol, ensuring that the most effective diagnostic strategies are identified efficiently.",[27,28,29,30],"Bloodstream Infection","Gram-Negative Infections","Gram-Positive Infections","Bacteremia Sepsis",[32,33,34,30],"Blood Stream Infection","Gram-negative Infections","Gram-positive Infections","RECRUITING","2026-06-21",{"date":38,"type":39},"2026-06-24","ACTUAL",{"date":41,"type":39},"2026-03-19",{"date":43,"type":21},"2028-03-19",{"name":45,"class":46},"Istituto Clinico Humanitas","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100571234","pkpd-relationship-of-cazavi-and-fos-in-the-treatment-of-patients-with-infections-due-to-cre-100571234","NCT06717594","PK\u002FPD Relationship of CAZ\u002FAVI and FOS in the Treatment of Patients With Infections Due to CRE","PK\u002FPD Relationship of CAZ\u002FAVI and FOS in the Treatment of Patients With Infections Due to Carbapenem-resistant Enterobacterales (CRE)","CAVIFOS","Inclusion Criteria:\n\n* Signature of the informed consent\n* Age ≥ 18 years\n* Adult patients treated for ≥ 48 hours with CAZ\u002FAVI or CAZ\u002FAVI plus FOS for a microbiologically documented CRE infection\n\nExclusion Criteria:\n\n* Polymicrobial\u002Fmixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs",{"count":57,"type":21},60,"OBSERVATIONAL","A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime\u002Favibactam (CAZ\u002FAVI) alone or with CAZ\u002FAVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and\u002For OXA-48).",[61,62],"Gram Negative Infections","Antimicrobial Resistance (AMR)",[64,65,66,67,68],"Gram negative infection","Ceftazidime\u002FAvibactam","Fosfomycin","Pharmacokinetics\u002FPharmacodynamics targets","Carbapenem-resistant Enterobacterales (CRE)","2026-06-11",{"date":71,"type":39},"2026-06-12",{"date":73,"type":39},"2023-12-01",{"date":75,"type":21},"2026-12-31",{"name":77,"class":46},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100579788","phase-2-a-study-to-assess-how-vaborem-is-taking-up-in-the-body-and-tolerated-in-paediatric-patients-with-gram-negative-infections-including-but-not-restricted-to-complicated-urinary-tract-infections-100579788","NCT06828848","A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections","An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections","Main Inclusion Criteria:\n\n* Written informed consent before initiation of any study-related procedures.\n* Male or female, from birth to \\\u003C 18 years of age, inclusive.\n* Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator's judgement.\n* Gram negative infection, according to diagnostic criteria for complicated urinary tract infection\u002Facute pyelonephritis (cUTI\u002FAP), complicated intra-Abdominal Infections (cIAI), Hospital-Acquired Pneumonia\u002FVentilator Associated Pneumonia (HAP\u002FVAP), Blood-Stream Infection (BSI).\n\nMain Exclusion Criteria:\n\n* History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product.\n* Gram negative infection that in the opinion of the Investigator is unlikely to respond to the study treatment.\n* In treatment with immunosuppressive agents, valproic acid, or probenecid.","0 Months","17 Years",{"count":89,"type":21},44,[91],"PHASE2","The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to \\\u003C 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration.\n\nAll participants will receive Vaborem IV every 8 hours to treat the suspected or confirmed Gram negative infections for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration.\n\nParticipant's clinical conditions will be monitored during the entire duration of the hospitalization and during scheduled visit\u002Fs after the completion of the treatment.",[61],[95,96,97,98,99,100],"pediatric","meropenem","vaborbactam","vaborem","gram negative infection","neonate","2026-02-03",{"date":103,"type":39},"2026-02-04",{"date":105,"type":39},"2025-02-18",{"date":107,"type":21},"2026-07",{"name":109,"class":110},"Menarini Group","INDUSTRY",22,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":47},"100621554","antibiotic-duration-and-outcomes-in-high-risk-febrile-neutropenia-patients-100621554","NCT07372131","Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients","Appropriate Management of Bacteriemic Febrile Neutropenia in High-Risk Hematological Patients. Relationship Between Duration of Antibiotic Administration, Outcome and Resistance Profile","PERaSTrA","Inclusion Criteria:\n\n* Diagnosed with a hematologic malignancy that is candidate for treatment with chemotherapy or bone marrow transplantation or chimeric antigen receptor T cell therapy (CAR-T)\n* Diagnosis of febrile neutropenia defined according to the guidelines of the Infectious Disease Society of America, IDSA; ref: Freifeld, A.G., et al., Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis, 2011. 52(4): p. e56-93.) as: Fever: single record of oral temperature \\>=38.3°C or a temperature \\>=38.0°C sustained over a period of one hour; Neutropenia: absolute neutrophil count \\\u003C 1000 cells\u002FmicroL; Expected duration of neutropenia \\>= 7 days\n* Diagnosis of bacteraemia defined by positive blood cultures (at least 1 vial positive for a non-contaminating microorganism)\n* Isolation of Gram-Negative species\n\nExclusion Criteria:\n\n* Contextual diagnosis of pneumonia\n* Contextual diagnosis of intra-abdominal infection, in particular: neutropenic enterocolitis\u002Ftyphlitis or biliary tract infection\n* Persistently positive blood cultures at randomization\n* Any condition that endangers the safety of the patient based on the judgment of the treating physician",{"count":121,"type":21},172,[24],"The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia.\n\nThe main questions it aims to answer are:\n\n* Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety?\n* How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution?\n\nResearchers will compare:\n\n* Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours.\n* Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision.\n\nParticipants will:\n\n* Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood.\n* Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival.\n* If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28).\n* Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.",[27,61,125,126],"Bacteraemia Caused by Gram-Negative Bacteria","Febrile Neutropenia (FN)",[128,27,129,130],"Antibiotics","Hematological patients with febrile neutropenia","Gram-negative","2026-01-20",{"date":133,"type":39},"2026-01-28",{"date":135,"type":39},"2025-05-10",{"date":137,"type":21},"2026-11-30",{"name":139,"class":46},"Humanitas University",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":54,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":47},"100597792","phase-3-a-combination-therapy-with-ceftazidime-and-fosfomycin-will-be-compared-to-ceftazidime-alone-in-hospitalized-adult-patients-with-suspected-severe-gram-negative-bacterial-infections-100597792","NCT07063095","A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections","Ceftazidime Plus Fosfomycin Versus Ceftazidime Alone for Severe Gram-negative Infections: a Triple-blind, Placebo-controlled Point-of-care Randomized Clinical Trial","Inclusion Criteria:\n\n1. Adult (≥18 years)\n2. Hospitalized with suspected severe Gram-negative bacterial infection\n3. Signed informed consent from the patient (or oral consent from a patient with capacity but with physical inability to sign, with signed witness testimony from a person independent of the study team) of from the legal representative if the patient lacks capacity to provide informed consent\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Known contra-indication to CAZ±AVI or FOS\n3. Gram-negative directed antibiotic treatment begun \\>24 hours before inclusion",{"count":148,"type":21},100,[150],"PHASE3","The goal of this clinical trial is to :\n\n1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time to normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and reduction in C-reactive protein (CRP) compared to standard of care (CAZ±AVI alone)\n2. to further characterize the safety profile of this combination therapy\n\nIn the presence of such an infection, standard treatment is to start intravenous antibiotic therapy. Ceftazidime (Fortam®), or ceftazidime-avibactam (Zavicefta®), is a standard antibiotic commonly used for this purpose (for very resistant bacteria, the compound avibactam is included to protect ceftazidime from being broken down by bacteria).\n\nResearchers will compare ceftazidime (or ceftazdime-avibactam) plus fosfomycin versus ceftazidime alone with placebo (i.e. a look-alike substance given with no drug) to examine whether the addition of another intravenous antibiotic, fosfomycin, would lead to faster recovery from severe infection and evaluate the tolerability of this combination.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention group or the control group.\n* The intervention group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected, per routine practice) and intravenous fosfomycin, and the control group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected) and placebo.\n* Either treatment will be given for 3 days, three times daily (or less frequently, depending on renal function).\n* Provide a few extra blood samples (for CRP measurement, a protein marker of inflammation) during the first few days of the study.\n* Be contacted in the hospital or by phone if discharged on day 28 to be asked a few questions.",[61,153],"Sepsis and Septic Shock",[155,156,157,158],"ceftazidime","cavifos","gram-negative bacteria","intravenous fosfomycin","2025-09-25",{"date":161,"type":39},"2025-09-26",{"date":163,"type":39},"2025-08-25",{"date":165,"type":21},"2026-12",{"name":167,"class":46},"Angela HUTTNER"]