[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioVersys SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"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":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100640409","phase-1-a-single-centre-open-label-2-period-fixed-sequence-phase-i-clinical-study-to-evaluate-the-effect-of-bv100-on-the-pharmacokinetics-of-polymyxin-b-in-healthy-volunteers-100640409",false,"NCT07580586","A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers","BV100-011 A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers","Main Inclusion Criteria:\n\n1. Participants who were able to understand and follow instructions during the study.\n2. Participants who signed informed consent.\n3. Male participants ≥ 18 and ≤ 55 years of age; female participants ≥ 18 and ≤ 55 years of age of non-childbearing potential and non-lactating, with absence of childbearing potential defined as follows:\n\n   1. Female participants 50 years of age or older, in menopause for 24 consecutive months and not receiving any hormone replacement therapy within 24 months prior to inclusion into the study\n   2. Female participants who underwent surgical sterilization\n   3. Female participants who underwent hysterectomy\n   4. Female participants with documented premature ovarian failure\n4. Weight within a BMI range of 19.0 - 30.0 kg\u002Fm2.\n5. Estimated glomerular filtration rate (eGFR) according to the MDRD formula : \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nMain Exclusion Criteria:\n\n1. Unwilling or unable to give informed consent.\n2. As a result of the medical screening process, the study physician considered the participant unfit for the study.\n3. Male participants with female partners who are lactating or pregnant.\n4. Known or suspected history of hypersensitivity to rifabutin or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin.\n5. Known or suspected history of hypersensitivity to polymyxin B or colistin.\n6. History of allergic reactions leading to hospitalization or any other allergic conditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the Investigator considers may affect the safety of the participant and\u002For outcome of the study.\n7. History of antibiotic associated diarrhoea within the last year.\n8. Participants with ECG abnormalities (history, or evidence of second-degree heart block of Mobitz type II, third degree heart block, or any abnormality considered relevant by the Investigator), QTcF \\> 450 ms, PR \\> 210 ms, or QRS duration \\> 110 ms.\n9. Supine systolic blood pressure \\> 150 mmHg or \\\u003C 95 mmHg or diastolic blood pressure \\> 95 mmHg or \\\u003C 45 mmHg at Screening or Period 1 Day 1 prior to dosing (any clinically relevant abnormal blood pressure results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion). Pulse rate \\> 110 or \\\u003C 40 beats per minute at Screening or Period 1 Day 1 prior to dosing.\n10. Clinically relevant abnormal values for leukocytes (total WBC), neutrophils, and lymphocytes (total), above the upper level of normal (ULN) or below the lower limit of normal (LLN) at screening, at the Investigator's discretion. Any clinically relevant abnormal value of these parameters may be repeated during screening.\n11. Clinically relevant abnormal values for Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and creatinine, above the ULN at Screening, at the Investigator's discretion. Any clinically relevant abnormal value of these parameters may be repeated during screening.\n12. Screening laboratory test values other than AST, ALT, ALP, creatinine, leucocytes, lymphocytes or neutrophils for haematology, biochemistry, or urinalysis must not exceed the reference range. Minor deviations from normal are allowed, if they are not considered clinically significant by the Investigator.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is an open-label, fixed sequence Phase I clinical study to evaluate the effect of multiple doses of BV100 on the PK of polymyxin B in healthy participants (HPs).",[28],"Healthy Adult Participants","RECRUITING","2026-05-05",{"date":32,"type":33},"2026-05-12","ACTUAL",{"date":35,"type":33},"2026-03-22",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"BioVersys SAS","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":41},"100618047","phase-3-efficacy-and-safety-of-bv100-plus-low-dose-polymyxin-b-versus-colistin-plus-high-dose-ampicillinsulbactam-in-patients-with-hospital-acquired-or-ventilator-associated-bacterial-pneumonia-due-to-carbapenem-resistant-acinetobacter-baumannii-calcoaceticus-complex-100618047","NCT07326540","Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin\u002FSulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","A Phase 3 Prospective, Randomized, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of BV100 Plus Low-dose Polymyxin B Compared With Colistin Plus High-dose Ampicillin\u002FSulbactam in the Treatment of Adult Patients With Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","RIV-TARGET","Inclusion Criteria:\n\n1. Provide written informed consent prior to any study related procedures not part of normal medical care. If permitted by local country and institution-specific guidelines, surrogate consent\u002Fuse of a legally authorized representative may be provided. Alternatively, the decision can be made according to the procedure permitted by local law and institutional Standard Operating Procedures. If a patient regains consciousness while in the study and, per the Investigator's judgment, the patient is able to read, assess, understand, and make his\u002Fher own decision to participate in the study, the patient may agree to continue participation. In such cases, the patient must be reconsented.\n2. Male or female patients, ≥ 18 and ≤ 82 years of age at the time of signing informed consent.\n3. A confirmed diagnosis of HABP or VABP requiring treatment with IV antibiotics in the judgment of the Investigator.\n4. High probability of a pneumonia (HABP or VABP) due to ABC as a single pathogen, or member of a polymicrobial infection based on evidence from RDT from a sample collected within 48 hours prior to randomization, AND one of the following:\n\n   1. Has received no more than 48 hours of potentially active antimicrobial treatment against CRABC prior to the first dose of study drug; OR\n   2. Is clinically failing prior treatment regimens (i.e., clinical deterioration or failure to improve after at least 48 hours of antibiotic treatment).\n5. An APACHE II \\\u003C 30 or qSOFA score ≥ 2 at Screening.\n6. Women of childbearing potential must have a negative highly sensitive urine or serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use one highly effective method of contraception from Screening until at least 30 days after administration of the last dose of study drug.\n7. Diagnosed with HABP or VABP\n\nExclusion Criteria:\n\n1. For Part A only, patients with an infection known to be resistant to colistin, with a known intolerance to polymyxins, or taking any drug that prevents them from receiving polymyxins.\n2. Evidence of active concurrent pneumonia requiring additional antimicrobial treatment caused by, e.g., Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Pneumocystitis jiroveci, Aspergillus spp, respiratory syncytial virus, influenza and parainfluenza viruses, Middle East respiratory syndrome coronavirus, mycobacteria, mucormycosis.\n3. Any of the following health conditions:\n\n   1. Pulmonary disease that precludes evaluation of a therapeutic response.\n   2. Pleural empyema (exception: acceptable if drainage occurs within 24 hours of Screening and patient is expected to be treated in ≤ 14 days).\n   3. Solid organ transplant within 6 months prior to randomization.\n   4. Evidence of deep seated infection, e.g., Gram-negative osteomyelitis, or meningitis requiring prolonged therapy.\n   5. Acute infective endocarditis due to Gram-positive bacteria that requires urgent treatment\u002Femergent indication of surgery, or patients in whom surgery is contraindicated due to prohibitive risk for surgery due to comorbidities.\n   6. Surgical wound infections requiring further surgical management e.g., wound closure, drain removal.\n   7. Peritonitis.\n   8. Irremovable implantable device or line thought to be the source of the ABC infection.\n   9. Known or suspected neuropathy or neuromuscular disease.\n   10. Human immunodeficiency virus infection.\n   11. Chronic immunosuppression due to drugs and\u002For underlying disease\n4. Bronchial obstruction or a history of post obstructive pneumonia (this does not exclude patients with pneumonia who have an underlying chronic obstructive pulmonary disease).\n5. 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 by the clinical team as receiving palliative or comfort-focused care.\n6. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg\n7. Diagnosis of ventilator-associated tracheobronchitis.\n8. Inability to provide proper respiratory specimens for culture.\n9. Received more than 48 hours of potentially active treatment against CRABC prior to the first dose of study drug.\n10. Known or suspected allergy to polymyxin, rifabutin, colistin, ampicillin\u002Fsulbactam, meropenem or their excipients.\n11. Acute graft-versus-host disease (Grade ≥ 3).\n12. Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.\n13. Requirement at the time of randomization for any reason, or likely to require during the patient's participation in the study (from randomization through the EoS Visit), for additional systemic Gram-negative antimicrobial therapy potentially active toward CRABC.\n14. Expected survival \\\u003C 72 hours or a Do Not Resuscitate Order.\n15. Burns \\> 40% of total body surface area.\n16. 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.\n17. 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.\n18. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3× upper limit of normal (ULN) AND total bilirubin \\> 2×ULN at Screening (using local laboratory values); or Child Pugh Class C in patients with chronic liver function impairment. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis, hepatic cirrhosis, hepatic failure, chronic ascites, or hepatic encephalopathy.\n\n    Note: Patients with AST or ALT up to 5×ULN are eligible if these elevations are acute and are documented as being directly related to the infectious process being treated.\n19. Investigator's opinion of clinically significant ECG finding such as new ischemic changes, infarct, or ventricular arrhythmia with immediate potential for a fatal outcome, bradycardia not corrected by pacemaker or medication, or, prior to the current infection, a history of New York Heart Association Class IV cardiac failure defined as severe limitations - experiences symptoms even while at rest, mostly bedbound patients, within 1 year.\n20. Abnormal QT interval corrected for heart rate by Fridericia formula (QTcF): \\> 500 ms confirmed with repeat ECG.\n21. Stroke (ischemic or intracerebral hemorrhage) within 10 days prior to randomization or expected survival from stroke \\\u003C 28 days or Glasgow Coma Scale score 3 with no hope of improvement.\n22. Women who are pregnant or nursing.\n23. Patients who are currently enrolled in or have not yet completed, in the last 30 days or 5 half lives, whichever is longer, another investigational device or drug study or those who are receiving other investigational agents.\n24. Unable or not willing, in the opinion of the Investigator, to comply with all study protocol.","82 Years",{"count":52,"type":22},248,[54],"PHASE3","This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC).\n\nPart B is the single-group portion of the study and includes patients with HABP or VABP with CRABC infections that are resistant to or have failed colistin\u002Fpolymyxin B treatment.",[57,58,59,60],"Hospital Acquired Bacterial Pneumonia (HABP)","Ventilator Associated Bacterial Pneumonia (VABP)","Colistin Resistanrt ABC","Acinetobacter Baumannii-calcoaceticus Complex",[62,63,64,65,66,67],"BV100","CRABC","VABP","HABP","polymyxin B","colistin","2026-04-28",{"date":70,"type":33},"2026-05-04",{"date":72,"type":33},"2026-03-27",{"date":74,"type":22},"2028-03-30",{"name":39,"class":40},""]