[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioVersys AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100619865","phase-2-phase-2a-trial-of-alpibectir-plus-ethionamide-for-tuberculosis-meningitis-100619865",false,"NCT07350174","Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis","A Multicenter, Open-label, Randomized, Active-controlled, Phase 2a Study to Evaluate the Pharmacokinetics and Safety of Alpibectir\u002FEthionamide in Combination With the Standard Regimen in Patients With Tuberculosis Meningitis.","Inclusion Criteria:\n\n1. Age ≥ 15 years and \\\u003C 65 years\n2. Diagnosis of TBM defined as \"definite\" or \"probable\", using criteria proposed by the Tuberculosis Meningitis International Research Consortium.\n\n   * Definite TBM is defined by at least one of the following criteria: acid-fast bacilli (AFB) seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test in the setting of symptoms suggestive of meningitis.\n   * Probable TBM is defined using a modified Marais score\\* Probable TBM: total score\\* ≥ 12 when neuroimaging is available, or ≥ 10 when neuroimaging is not available. At least 2 points should come from CSF or 2 points from cerebral imaging criteria.\n\n   (\\*see Appendix 2: Modified Marais Score)\n3. Informed consent signed by the patient. For patients with Glasgow Coma Scale (GCS) \\\u003C 15, the consent of a next of kin\u002Frelative will be required, in accordance with applicable local laws and regulations. Deferred consent will be obtained from the participant when their level of consciousness improves, and they have capacity to provide consent. For adolescents below the age of civil majority (as defined in each country), the consent of at least one parent or legal guardian and the assent of the adolescent will be required.\n\nExclusion Criteria:\n\n1. Having received \\>14 days of HRZE TB treatment.\n2. In people with HIV infection: use of antiretroviral treatment (ART) other than efavirenz- or dolutegravir-based.\n3. Glasgow Coma Scale \\\u003C 10.\n4. Body weight measured or estimated: \\\u003C 40 kg or \\> 90 kg or BMI \\> 40 kg\u002Fm2.\n5. Renal failure (eGFR \\\u003C 30 mL\u002Fmin, calculated by CKD-EPI formula).\n6. Alanine aminotransferase (ALT) \\> 5 times the Upper Limit of Normal.\n7. Clinical evidence of liver failure or decompensated cirrhosis.\n8. For women of childbearing potential, one or more of the following:\n\n   1. Being pregnant, breast-feeding, or intending to breast-feed or conceive a child during the study or within 30 days after the end of treatment visit (D56), OR;\n   2. Not willing or able to use highly effective contraceptive methods (as defined per Appendix 7) starting at screening and continuing until 30 days after the end of treatment visit (D56).\n9. For male participants: intending to conceive a child or not willing or able to consistently use a barrier method e.g. condoms during all sexual activity from inclusion until 90 days after the end of treatment visit (D56).\n\n   Note: Male participants should be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse.\n10. Documented Mtb resistance to rifampicin.\n11. Positive Gram-stain, bacterial culture other than Mtb or cryptococcal antigen in the CSF.\n12. For HIV positive patients: Presence of cryptococcal antigen in the blood.\n13. Inability to collect CSF or contraindication to lumbar puncture (LP).","ALL","15 Years","64 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","AlpE is a novel drug combination under development for the treatment of TB, with several positive attributes for TBM, including rapid bactericidal activity. The current trial aims to assess the plasma and CSF PK, as well as the safety and tolerability of alpibectir and three doses of Eto in patients with newly diagnosed TBM. Additionally, it is attended to investigate the effect of AlpE on the PK and efficacy of DTG during the first month of antiretroviral treatment (ART) for Human Immunodeficiency Virus (HIV)-positive patients.",[27],"Tuberculosis Meningitis",[29],"Tuberculosis, AlpE, Ethionamide, CSF, pharmacokinetics","NOT_YET_RECRUITING","2026-02-28",{"date":33,"type":34},"2026-03-03","ACTUAL",{"date":36,"type":21},"2026-03-30",{"date":38,"type":21},"2028-10-30",{"name":40,"class":41},"BioVersys AG","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"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":53,"type":21},120,[24],"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.",[57,58,59,60,61],"Ventilator Associated Bacterial Pneumonia (VABP)","Hospital Acquired Bacterial Pneumonia (HABP)","Blood Stream Infection","Meningitis, Bacterial","Ventriculitis, Infectious",[63,64,65,66,67,68],"VABP","BV100","HABP","BSI","CNS infection","BioVersys","2026-02-23",{"date":71,"type":34},"2026-02-24",{"date":73,"type":21},"2026-07",{"date":75,"type":21},"2028-07",{"name":40,"class":41},""]