A Phase 2 interventional study of BV100 with 50 mg polymyxin B plus ceftazidime/avibactam and BV100 with 50 mg polymyxin B plus cefiderocol in Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP) and Blood Stream Infection, sponsored by BioVersys AG. Not yet recruiting. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by BioVersys AG · Phase 2, Interventional, and Treatment
This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam 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.
Part A will be the randomized, active-controlled portion of the study, evaluating patients with suspected or confirmed CRABC nosocomial pneumonia (VABP and HABP) and BSI of non-urinary tract origin. This is an open-label study, and therefore, no blinding will be done.
In Part A, patients will be randomized 1:1:1, to one of the three treatment groups until the CRABC m-MITT population includes 30 evaluable subjects per group:
Group 3: Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history.
In case of non-Acinetobacter metallo-beta-lactamase (MBL)-producing infections confirmed by culture or identified by RDT, including polymicrobial infections,, aztreonam (2 g infused over 2 hours, q8h) should be infused simultaneously with ceftazidime-avibactam via a Y-site administration used per manufacturer's instructions, subject to Medical Monitor approval.
In Part A, no more than 30 patients with HABP will be enrolled across all treatment groups.
Part B is a prospective multicenter, open label, non-randomized, additional single cohort to evaluate the PK, safety, and efficacy BV100 in combination with both low dose polymyxin B and cefiderocol in patients with CRABC ventriculitis or meningitis. Optional intrathecal or intraventricular administration of polymyxin B or colistin, as well as dexamethasone therapy per local treatment standards, is permitted. After 14 days of treatment with BV100 and low dose polymyxin B, the BV100 therapy must be stopped, but patients may continue therapy with cefiderocol and best available additional therapy at the discretion of the investigator and as needed. Functioning external ventricular drains (EVDs) are required for safe and timely CSF sampling.
Approximately 10 patients are expected to be enrolled in part B, with enrollment concluding once the last patient in Part A is recruited.
38 studies on the registry are indexed under Meningitis, Bacterial; 11 are open to participants now.
This study's planned enrollment of 120 is below the median of 226 across 22 interventional studies indexed under Meningitis, Bacterial.
Browse Meningitis, Bacterial studies →BioVersys AG is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Acute Physiology and Chronic Health Evaluation (APACHE II) score ≤ 30, within 24 hours prior to randomization.
Part B specific inclusion criteria
Main Exclusion Criteria:
1. 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.
4. 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.
6. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg (calculate mean arterial pressure = diastolic pressure plus 1/3 (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/avibactam, cefiderocol, or their .
8. Inability to insert a central catheter or a peripherally inserted central catheter (PICC).11. Acute Grade ≥ 3.
12. Expected survival \< 72 hours or a Do Not Resuscitate Order. 13. Burns > 40% of total body surface area. 14. Presence of neutropenia ( \< 1500/mm3) obtained from a local laboratory at Screening, or anticipated neutropenia with absolute neutrophil count \< 1500 cells/mm3.
15. Severe renal disease defined as an estimated (eGFR) as per Modification of Diet in Renal Disease (MDRD) formula (MDRD eGFR) \< 30 mL/min/1.73 m2, or requirement for peritoneal dialysis, hemodialysis, hemofiltration, or a urine output \< 20 mL/hour over a 24 hour period.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BV100 with 50 mg polymyxin B plus ceftazidime/avibactam
Drug: BV100 with 50 mg polymyxin B plus cefiderocol
Drug: Best Available Therapy (BAT)
Drug: BV100 with 50 mg polymyxin B plus cefiderocol
Drug pages: BV100 · Polymyxin B · Ceftazidime · Avibactam
300 mg BV100 in combination with 500,000 IU (50 mg) polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g/0.5 g ceftazidime/avibactam\*,# infused over 2 hours every 8 hours (q8h).
Drug pages: BV100 · Polymyxin B · 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).
Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history.
The incidence of treatment-related treatment emergent adverse events (TRTEAEs) in the Safety population, assessed through End of Study (EoS) visit in Part A and Part B.
Time frame: 30 days
28-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.
Time frame: 28 days
Clinical cure at Test of Cure (ToC) in the CRABC m-MITT population in Part A.
Time frame: 21 days
Concentration of rifabutin and 25-O-deacetyl-rifabutin in CSF and plasma at steady state in Part B
Time frame: 7 days
14-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.
Time frame: 14 days
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: BV100 · Polymyxin B · Ceftazidime · Avibactam · Cefiderocol
BioVersys AG