Ventilator Associated Bacterial Pneumonia (VABP)Phase 2RIV- CARENCT07431307

Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex

A Phase 2 study testing BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol and Best Available Therapy (BAT) in people with Ventilator Associated Bacterial Pneumonia (VABP) and Hospital Acquired Bacterial Pneumonia (HABP), run by BioVersys AG.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 82 years
Conditions the study is for: Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection
What is being tested?: BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol and Best Available Therapy (BAT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: Jul 2026to Jul 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 82 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent prior to any study-related procedures not part of normal medical care. Surrogate consent/use of a legally authorized representative may be provided if permitted by local country and institution-specific guidelines
Male subjects or female subjects ≥ 18 and ≤ 82 years of age at the time of signing informed consent.
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
Diagnosed with HABP, VABP or BSI
Acute Physiology and Chronic Health Evaluation (APACHE II) score ≤ 30, within 24 hours prior to randomization.
Part B specific inclusion criteria

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Confirmed CRABC ventriculitis or meningitis based on evidence from CSF culture collected within 72 hours prior to enrollment (as per standard of care).
Functioning EVD that can be used for safe and timely CSF sampling.
No contraindications to CSF sampling via EVD in the volumes required by the protocol
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 excipients.
8. Inability to insert a central catheter or a peripherally inserted central catheter (PICC).11. Acute graft versus host disease 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 (absolute neutrophil count < 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 glomerular filtration rate (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.

Who cannot join

None listed.

About this study

Official title: 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/Avibactam, 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

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.

Read the detailed description

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 1: 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).
Group 2: 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).
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.
If rapid diagnostic test (RDT) on positive blood culture broths show Acinetobacter only, concomitant ceftazidime-avibactam can be omitted.

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.

Conditions: Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection, Meningitis, Bacterial, Ventriculitis, Infectious
Being tested: BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT)
Keywords: VABP, BV100, HABP, BSI, CNS infection, BioVersys
Medical subject headings: Meningitis, Bacterial, Cerebral Ventriculitis, Central Nervous System Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BV100 with 50 mg polymyxin B plus ceftazidime/avibactamDrug
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).
BV100 with 50 mg polymyxin B plus cefiderocolDrug
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)Drug
Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history.

Study groups in NCT07431307
Study group	Role	What they receive
Part A - Group 1	Experimental	Not described Receives: Drug: BV100 with 50 mg polymyxin B plus ceftazidime/avibactam
Part A - Group 2	Experimental	Not described Receives: Drug: BV100 with 50 mg polymyxin B plus cefiderocol
Part A - Group 3	Active comparator	Not described Receives: Drug: Best Available Therapy (BAT)
Part B	Experimental	Not described Receives: Drug: BV100 with 50 mg polymyxin B plus cefiderocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Secondary outcomes (4)

28-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.
Measured: 28 days
Clinical cure at Test of Cure (ToC) in the CRABC m-MITT population in Part A.
Measured: 21 days
Concentration of rifabutin and 25-O-deacetyl-rifabutin in CSF and plasma at steady state in Part B
Measured: 7 days
14-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2026Jul 2028

First posted24 Feb 2026
Study startJul 2026 (estimated)
Primary completionMar 2028 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ventilator Associated Bacterial Pneumonia (VABP)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07431307
Sponsor's protocol ID: BV100-012
Other IDs: 2026-525542-30-00
Acronym: RIV- CARE
Status last verified: Feb 2026
First submitted: 17 Feb 2026
Last updated: 24 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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