[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"meningitis-bacterial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:meningitis-bacterial":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,91,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100603302","febrile-infants-swedish-study-100603302",false,"NCT07134751","Febrile Infants Swedish Study","FISS","Inclusion Criteria:\n\n* Temperature ≥38.0 C (measured either at home or at the pediatric emergency department)\n* Age ≤60 days","ALL","60 Days",{"count":19,"type":20},2000,"ESTIMATED","OBSERVATIONAL","Approximately one million febrile infants aged ≤60 days present annually to pediatric emergency departments (PEDs) in Europe and the United States. Although fewer than 5% are diagnosed with meningitis or bacteremia (invasive bacterial infections - IBIs), and 10-15% with urinary tract infections (UTIs), current guidelines recommend extensive diagnostic evaluations, hospitalization, and empirical treatment with broad-spectrum parenteral antibiotics. This approach may contribute to medical overuse, with implications for patient care, healthcare resource utilization, and environmental sustainability.\n\nThe Febrile Infants Swedish Study (FISS) is a prospective observational study conducted across 11 PEDs in Sweden. All febrile infants aged ≤60 days presenting to participating sites will be eligible. A new clinical guideline for the management of infants with fever without source (FWS) will be implemented in 7 PEDs, while 4 PEDs will continue with current standard practice and serve as a comparison group.\n\nThe study is expected to run for approximately two years and aims to recruit a minimum of 2,500 febrile infants",[24,25,26,27,28,29,30],"Febrile Illness Acute","Meningitis, Bacterial","Urinary Tract Infection (Diagnosis)","Invasive Bacterial Infection","Serious Bacterial Infection","Bacteremia","Sepsis",[32,33,34,35,36,37,38],"Guidelines","Febrile infants","Age ≤60 days","Management","Serious Bacterial Infections","Invansive Bacterial Infections","Clinical prediction tool","RECRUITING","2026-04-01",{"date":42,"type":43},"2026-04-02","ACTUAL",{"date":45,"type":43},"2025-12-01",{"date":47,"type":20},"2028-09-30",{"name":49,"class":50},"Region Skane","OTHER",11,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"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.","18 Years","82 Years",{"count":63,"type":20},120,"INTERVENTIONAL",[66],"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.",[69,70,71,25,72],"Ventilator Associated Bacterial Pneumonia (VABP)","Hospital Acquired Bacterial Pneumonia (HABP)","Blood Stream Infection","Ventriculitis, Infectious",[74,75,76,77,78,79],"VABP","BV100","HABP","BSI","CNS infection","BioVersys","NOT_YET_RECRUITING","2026-02-23",{"date":83,"type":43},"2026-02-24",{"date":85,"type":20},"2026-07",{"date":87,"type":20},"2028-07",{"name":89,"class":90},"BioVersys AG","INDUSTRY",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":64,"phases":99,"briefSummary":101,"conditions":102,"keywords":108,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100626167","prediction-of-infectious-agents-in-the-biofire-filmarray-biomrieux-meningitisencephalitis-panel-based-on-clinical-syndrome-and-cerebrospinal-fluid-parameters-a-diagnostic-stewardship-proposal-100626167","NCT07432113","Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis\u002FEncephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.","Inclusion Criteria:\n\nPatients aged 18 years or older, of any gender.\n\nPresence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.\n\nSymptoms must have started within the last 30 days.\n\nObligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells\u002Fmm³).\n\nProvision of written Informed Consent (TCLE) by the patient or their legal representative.\n\nExclusion Criteria:\n\n* Failure to sign the Informed Consent Form.\n\nClinical manifestations lasting more than 30 days.\n\nPatients under 18 years of age.\n\nPatients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).",{"count":98,"type":20},182,[100],"NA","Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.\n\nObjective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis\u002FEncephalitis panel in patients with clinical syndrome of meningitis and\u002For encephalitis and pleocytosis (CSF ≥ 5 cells).\n\nAs secondary objectives, the study aims to:\n\nDetermine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.\n\nCompare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.\n\nCompare the time for identification of the causative pathogen and mortality rates between the study groups.\n\nPerform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.\n\nMethods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.",[103,104,105,106,107,25],"Meningitis","Encephalitic Infection","Encephalitis","Meningitis, Fungal","Meningitis, Viral",[109,110,111,112,113],"filmarray","biofire","biofire filmarray","meningits","encephalitis","2026-02-18",{"date":116,"type":43},"2026-02-25",{"date":118,"type":20},"2026-03-16",{"date":120,"type":20},"2029-10-31",{"name":122,"class":50},"Federal University of Health Science of Porto Alegre",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":134,"conditions":135,"keywords":148,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100284234","fosfomycin-iv-for-treatment-of-severely-infected-patients-100284234","NCT02979951","Fosfomycin I.v. for Treatment of Severely Infected Patients","An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.","FORTRESS","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with \"do not resuscitate order\"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection",{"count":133,"type":20},1000,"The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.",[136,137,138,139,25,105,140,141,142,143,144,145,146,30,29,147],"Bacterial Infections","Bone Diseases, Infectious","Osteomyelitis","Central Nervous System Bacterial Infections","Brain Abscess","Urinary Tract Infections","Respiratory Tract Infections","Pneumonia, Bacterial","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Endocarditis, Bacterial",[149,150,151,152,153,154,155,156,157,158,136,159,160,137,138,139,25,105,140,141,142,143,144,145,146,30,29,147,161,162,163,164],"Observational Study","Non-Interventional Study","Registries","Prospective","Monitored","Multicentric","International","Fosfomycin","Infectofos","Fomicyt","Gram-Negative Bacterial Infections","Gram-Positive Bacterial Infections","Treatment Outcome","Clinical Efficacy","Microbiological Efficacy","Safety","2024-09-27",{"date":167,"type":43},"2024-10-01",{"date":169,"type":4},"2016-12",{"date":171,"type":20},"2030-12",{"name":173,"class":90},"Infectopharm Arzneimittel GmbH",50]