[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626105":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":40,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":11},{"fullName":5,"class":6},"BioVersys AG","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A - Group 1","EXPERIMENTAL",null,[13],"Drug: BV100 with 50 mg polymyxin B plus ceftazidime\u002Favibactam",{"label":15,"type":10,"description":11,"interventionNames":16},"Part A - Group 2",[17],"Drug: BV100 with 50 mg polymyxin B plus cefiderocol",{"label":19,"type":20,"description":11,"interventionNames":21},"Part A - Group 3","ACTIVE_COMPARATOR",[22],"Drug: Best Available Therapy (BAT)",{"label":24,"type":10,"description":11,"interventionNames":25},"Part B",[17],[27,32,36],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","BV100 with 50 mg polymyxin B plus ceftazidime\u002Favibactam","300 mg BV100 in combination with 500,000 IU (50 mg) polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g\u002F0.5 g ceftazidime\u002Favibactam\\*,# infused over 2 hours every 8 hours (q8h).",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"BV100 with 50 mg polymyxin B plus cefiderocol","300 mg BV100 in combination with 500,000 IU (50 mg) polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g cefiderocol infused over 3 hours every 8 hours (q8h).",[15,24],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Best Available Therapy (BAT)","Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history.",[19],{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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",false,"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.","ALL","18 Years","82 Years",{"count":54,"type":55},120,"ESTIMATED","INTERVENTIONAL",[58],"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.",[61,62,63,64,65],"Ventilator Associated Bacterial Pneumonia (VABP)","Hospital Acquired Bacterial Pneumonia (HABP)","Blood Stream Infection","Meningitis, Bacterial","Ventriculitis, Infectious",[67,68,69,70,71,72],"VABP","BV100","HABP","BSI","CNS infection","BioVersys","NOT_YET_RECRUITING","2026-02-23",{"date":76,"type":77},"2026-02-24","ACTUAL",{"date":79,"type":55},"2026-07",{"date":81,"type":55},"2028-07",{"name":5,"class":6}]