Ventilator Associated PneumoniaPhase 2NCT05685615
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
A Phase 2 study testing BV100 plus Polymyxin B and BAT in people with Ventilator Associated Pneumonia, run by BioVersys AG at 16 sites in 3 countries.
Trial summary
A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- BV100 plus Polymyxin B and BAT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 20 Apr 2023to 11 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all the following diagnostic and clinical criteria are eligible for the study:
- 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. 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/her own decision to participate in the trial, the patient can agree to continue participation and the patient should be re consented, if required by local country and institution specific guidelines.
- Male or female patients ≥ and < 80 years of age at the time of Informed Consent Form (ICF) signing with a body mass index (BMI) of < 40 kg/m2 at the time of ICF signing.
- Hospitalized for ≥ 48 hours, intubated (via endo or nasotracheal tube, including tracheostomy patients) and receiving mechanical ventilation for ≥ 48 hours at the time of randomization, and with acute changes made in the ventilator support system to enhance oxygenation, as determined by arterial blood gas, or worsening PaO2/FiO2 ratio.
- All patients must have a chest radiograph or a lung CT scan within 48 hours prior to randomization showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia (based on Investigator's evaluation).
- Clinical findings to support diagnosis of VABP. At least 1 of the following must be documented to be present within 24 hours prior to randomization:
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- Documented fever (oral ≥ 38.0 °C [100.4 °F] or a tympanic, temporal, rectal, or core temperature ≥ 38.3 °C [101.0 °F], axillary or forehead scanner ≥ 37.5 °C [99.5 °F]) OR
- Hypothermia (rectal/core body temperature ≤ 35.0 °C [95.2 °F]), OR
- Leukocytosis with total peripheral white blood cell count (WBC) ≥ 10 000 cells/mm3, OR
- Leukopenia with total peripheral WBC count ≤ 4500 cells/mm3.
- Acute Physiology and Chronic Health Evaluation (APACHE II) score between 8 and 30, inclusive, within 24 hours prior to randomization. Any data collected before ICF signature as part of a routine standard for patient care (e.g., laboratory values, Glasgow Coma Score, Acute Physiology Score [APS]) can be used for Screening Visit assessment, if applicable, without repeating the assessments.
- High probability of pneumonia due to A. baumannii, defined as follows:
- RDT, performed within 36 hours prior to randomization, using an acceptable respiratory sample (PBS, BAL, mini BAL, or ETA) positive for A. baumannii, OR
- A surveillance culture from a respiratory sample positive for A. baumannii within 72 hours prior to randomization.
- Part B specific:
- Patients who have been treated previously with an empiric antibiotic regimen and have failed treatment, both clinically and microbiologically, if they have an identified CRAB which has been shown to be non-susceptible in vitro to each of the antibiotic(s) of the empiric antibiotic regimen or has been identified from a culture performed after at least 48 hours of empiric antibiotic regimen, AND/OR
- Has an infection caused by A. baumannii organisms known to be resistant to colistin (defined as MIC ≥ 4 mg/L by a non-agar-based method) based on evidence from culture or susceptibility testing after at least 48 hours of antibiotic treatment.
Who cannot join
- Patients who meet any of the following criteria are not eligible to participate in this study:
- Known or suspected community acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia.
- Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 60 mmHg
- Known or suspected allergy to polymyxin, rifabutin, BAT, or their excipients.
- Any of the following health conditions:
- Confirmed legionella infection (Legionella pneumophila pneumonia), Aspergillus spp. pneumonia (testing is not required)
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- Candida spp. infection requiring systemic treatment
- Cystic fibrosis
- Known or suspected Pneumocystitis jiroveci pneumonia
- Known or suspected active tuberculosis
- Lung abscess
- Solid organ transplant within 6 months prior to randomization
- Pleural empyema
- Evidence of deep seated infection outside the respiratory tract, e.g., endocarditis, osteomyelitis.
- Known or suspected neuropathy or neuromuscular disease
- Known HIV infection
- Bronchial obstruction or a history of post obstructive pneumonia (this does not exclude patients with pneumonia who have an underlying chronic obstructive pulmonary disease).
- Acute graft versus host disease Grade ≥ 3.
- Expected survival < 72 hours or a Do Not Resuscitate Order.
- Burns > 40% of total body surface area.
- Current or anticipated neutropenia with absolute neutrophil count < 1000 cells/mm3.
- Severe renal disease defined as an estimated creatinine clearance as per Cockcroft Gault (CLCR CG) < 30 mL/minute or estimated glomerular infiltration rate (eGFR) as per Modified Diet in Renal Disease (MDRD) equation < 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.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or bilirubin (conjugated/unconjugated) ≥ 3 × upper limit of normal (ULN) values used by the laboratory performing the test or Child Pugh Class B and 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.
- Received systemic or inhaled antibiotic therapy potentially effective against A. baumannii within 72 hours prior to randomization for ≥ 36 hours
- Investigator's opinion of clinically significant electrocardiogram (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 (NYHA) Class IV cardiac failure defined as severe limitations - experiences symptoms even while at rest, mostly bedbound patients, within 1 year.
- Abnormal QT interval corrected by Fridericia (QTcF): > 450 ms confirmed with repeat ECG.
- Stroke (ischemic or intracerebral hemorrhage) within 5 days prior to randomization.
- Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use an acceptable method of birth control (e.g., intra-uterine device [IUD], male partner sterilization, or complete sexual abstinence) for at least 30 days after the last dose of the study drug. Negative pregnancy test should be obtained before randomization. The following women are not considered to have childbearing potential: 1) those who have undergone surgical sterilization, including hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy, but excluding bilateral tubal occlusion; 2) age ≥ 50 and post-menopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments.
- Male patients with female partners of childbearing potential who are unwilling to use 2 methods of contraception, one of which must be a barrier method (e.g., condom), for at least 30 days after the last dose of study drug.
- Previous exposure to BV100.
- Patients who are currently enrolled in or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agents.
- Not willing to comply with all study procedures.
- Confirmed or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based on local standard-of-care assessments available during Screening, unless the suspected A. baumannii pneumonia is diagnosed 14 days or more after the detection of SARS CoV 2.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Georgia7 sites
Academician Vakhtang Bochorishvili Clinic
Tbilisi
Eristavi National Center of Experimental and Clinical Surgery
Tbilisi
First University Clinic of Tbilisi State Medical University
Tbilisi
Gudushauri National Medical Center
Tbilisi
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi
Number 5 Clinical Hospital
Tbilisi
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi
Greece6 sites
General Hospital of Athens "Evangelismos"
Athens
University General Hospital "Attikon"
Athens
General University Hospital of Heraklion
Heraklion
General Hospital of Larissa
Larissa
University General Hospital of Larissa
Larissa
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki
Hungary3 sites
University of Debrecen Clinical Center
Debrecen
University Educational Hospital
Miskolc
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár
About this study
Official title: A Multicenter, Open-label, Randomized, Active-controlled, Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Intravenous BV100 Combined with Polymyxin B Versus Best Available Therapy in Adult Patients with Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to Be Due to Carbapenem-resistant Acinetobacter Baumannii
A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB
Read the detailed description
A multicenter, open label, randomized, active controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available therapy in adult patients with ventilator associated bacterial pneumonia suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- BV100 plus Polymyxin B, BAT
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BV100 plus Polymyxin BDrug
Rifabutin for Infusion plus Polymyxin B for Injection
BATDrug
Also called Best Avaialble Therapy
The best avaialble antibiotic therapy to treat CRAB
| Study group | Role | What they receive |
|---|---|---|
| BV100 (200 mg) plus Polymyxin B | Experimental | BV100 (200 mg q12h) infused over 2 hours plus Polymyxin B (12 500-15 000 IU/kg) infused over 1h Receives: Drug: BV100 plus Polymyxin B |
| BV100 (300 mg) plus Polymyxin B | Experimental | BV100 (300 mg q12h) infused over 2 hours plus Polymyxin B (12 500-15 000 IU/kg) infused over 1h Receives: Drug: BV100 plus Polymyxin B |
| Best Available Therapy | Active comparator | Best Available Antibiotic Therapy to Treat CRAB Receives: Drug: BAT |
| Part B: BV100 plus BAT | Experimental | BV100 (300 mg q12h) infused over 2 hours plus Best Avaialble Therapy to Treat Colistin resistant CRAB Receives: Drug: BAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the pharmacokinetic (PK) properties of BV100 co administered with Polymyxin B during 7 to 14 days of treatment in patients with ventilator associated bacterial pneumonia (VABP)
Maximum Observed Plasma Concentration (Cmax) of rifabutin
Measured: 14 days
To investigate the pharmacokinetic properties of BV100 co administered with Polymyxin B during 7 to 14 days of treatment in patients with ventilator associated bacterial pneumonia (VABP)
Area Under the Plasma Concentration-Time Curve (AUC) of rifabutin
Measured: 14 days
Secondary outcomes (3)
To assess the 28 day ACM rates of BV100 plus Polymyxin B compared to best available therapy (BAT)
28 Day ACM
Measured: 28 Days
To assess the 14 day ACM rates of BV100 plus Polymyxin B compared to best available therapy (BAT)
14 Day ACM
Measured: 14
To assess safety and tolerability of BV100 plus Polymyxin B compared to best available therapy (BAT)
Number of Participants with Treatment-Emergent Adverse Events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start20 Apr 2023
- Primary completion1 Nov 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVersys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Husband, MD, Study director, BioVersys SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685615
- Sponsor's protocol ID
- BV100-006
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Active-controlled, Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Intravenous BV100 Combined with Polymyxin B Versus Best Available Therapy in Adult Patients with Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to Be Due to Carbapenem-resistant Acinetobacter Baumannii
- ClinicalTrials.gov ID
- NCT05685615
- Acronym / sponsor ID
- BV100-006
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BioVersys AGIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB
Detailed description
A multicenter, open label, randomized, active controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available therapy in adult patients with ventilator associated bacterial pneumonia suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BV100 (200 mg) plus Polymyxin B | Experimental | Drug: BV100 plus Polymyxin BBV100 (200 mg q12h) infused over 2 hours plus Polymyxin B (12 500-15 000 IU/kg) infused over 1h |
| BV100 (300 mg) plus Polymyxin B | Experimental | Drug: BV100 plus Polymyxin BBV100 (300 mg q12h) infused over 2 hours plus Polymyxin B (12 500-15 000 IU/kg) infused over 1h |
| Best Available Therapy | Active comparator | Drug: BATBest Available Antibiotic Therapy to Treat CRAB |
| Part B: BV100 plus BAT | Experimental | Drug: BATBV100 (300 mg q12h) infused over 2 hours plus Best Avaialble Therapy to Treat Colistin resistant CRAB |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients who meet all the following diagnostic and clinical criteria are eligible for the study:
- 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. 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/her own decision to participate in the trial, the patient can agree to continue participation and the patient should be re consented, if required by local country and institution specific guidelines.
- Male or female patients ≥ and < 80 years of age at the time of Informed Consent Form (ICF) signing with a body mass index (BMI) of < 40 kg/m2 at the time of ICF signing.
- Hospitalized for ≥ 48 hours, intubated (via endo or nasotracheal tube, including tracheostomy patients) and receiving mechanical ventilation for ≥ 48 hours at the time of randomization, and with acute changes made in the ventilator support system to enhance oxygenation, as determined by arterial blood gas, or worsening PaO2/FiO2 ratio.
- All patients must have a chest radiograph or a lung CT scan within 48 hours prior to randomization showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia (based on Investigator's evaluation).
Key exclusion criteria (33 listed)
- Patients who meet any of the following criteria are not eligible to participate in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BV100 plus Polymyxin BRifabutin for Infusion plus Polymyxin B for Injection | Drug | BV100 (200 mg) plus Polymyxin B, BV100 (300 mg) plus Polymyxin B |
| BATAlso: Best Avaialble TherapyThe best avaialble antibiotic therapy to treat CRAB | Drug | Best Available Therapy, Part B: BV100 plus BAT |
Primary outcome
To investigate the pharmacokinetic (PK) properties of BV100 co administered with Polymyxin B during 7 to 14 days of treatment in patients with ventilator associated bacterial pneumonia (VABP)
Time frame: 14 days
Maximum Observed Plasma Concentration (Cmax) of rifabutin
To investigate the pharmacokinetic properties of BV100 co administered with Polymyxin B during 7 to 14 days of treatment in patients with ventilator associated bacterial pneumonia (VABP)
Time frame: 14 days
Area Under the Plasma Concentration-Time Curve (AUC) of rifabutin
3 secondary outcomes
To assess the 28 day ACM rates of BV100 plus Polymyxin B compared to best available therapy (BAT)
Time frame: 28 Days
To assess the 14 day ACM rates of BV100 plus Polymyxin B compared to best available therapy (BAT)
Time frame: 14
To assess safety and tolerability of BV100 plus Polymyxin B compared to best available therapy (BAT)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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VAP - Ventilator Associated Pneumonia
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Husband, MD study director
BioVersys SAS
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BV100 plus Polymyxin B and BAT in people with Ventilator Associated Pneumonia, run by BioVersys AG at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Georgia, Greece, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the pharmacokinetic (PK) properties of BV100 co administered with Polymyxin B during 7 to 14 days of treatment in patients with ventilator associated bacterial pneumonia (VABP) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.