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Compares treatment options for Hospital Acquired Bacterial Pneumonia (HABP)
Official title Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
ClinicalTrials.gov ID: NCT07326540
What this study is testing
What is BV100 (300 mg)?
BV100 (300 mg) is an investigational medicine, being studied as a potential treatment for hospital acquired bacterial pneumonia (habp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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). Part 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/polymyxin B treatment.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 82
You may be able to join if
- Provide written informed consent prior to any study related procedures not part of normal medical care. If permitted by local country and...
- Male or female patients, ≥ 18 and ≤ 82 years of age at the time of signing informed consent.
- A confirmed diagnosis of HABP or VABP requiring treatment with IV antibiotics in the judgment of the Investigator.
- 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...
- Has received no more than 48 hours of potentially active antimicrobial treatment against CRABC prior to the first dose of study drug; OR
You likely can't join if
- 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...
- Evidence of active concurrent pneumonia requiring additional antimicrobial treatment caused by, e.g., Streptococcus pneumoniae, Haemophilus...
- Any of the following health conditions:
- Pulmonary disease that precludes evaluation of a therapeutic response.
- Pleural empyema (exception: acceptable if drainage occurs within 24 hours of Screening and patient is expected to be treated in ≤ 14 days).
- Solid organ transplant within 6 months prior to randomization.
See the full eligibility criteria
Who can join
- 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/use of a legally authorized...
- Male or female patients, ≥ 18 and ≤ 82 years of age at the time of signing informed consent.
- A confirmed diagnosis of HABP or VABP requiring treatment with IV antibiotics in the judgment of the Investigator.
- 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...
- Has received no more than 48 hours of potentially active antimicrobial treatment against CRABC prior to the first dose of study drug; OR
- Is clinically failing prior treatment regimens (i.e., clinical deterioration or failure to improve after at least 48 hours of antibiotic treatment).
- An APACHE II \< 30 or qSOFA score ≥ 2 at Screening.
- 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...
- Diagnosed with HABP or VABP
What rules you out
- 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.
- Evidence of active concurrent pneumonia requiring additional antimicrobial treatment caused by, e.g., Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae...
- Any of the following health conditions:
- Pulmonary disease that precludes evaluation of a therapeutic response.
- Pleural empyema (exception: acceptable if drainage occurs within 24 hours of Screening and patient is expected to be treated in ≤ 14 days).
- Solid organ transplant within 6 months prior to randomization.
- Evidence of deep seated infection, e.g., Gram-negative osteomyelitis, or meningitis requiring prolonged therapy.
- Acute infective endocarditis due to Gram-positive bacteria that requires urgent treatment/emergent indication of surgery, or patients in whom surgery is contraindicated due to prohibitive risk for surgery due to...
- Surgical wound infections requiring further surgical management e.g., wound closure, drain removal.
- Peritonitis.
- Irremovable implantable device or line thought to be the source of the ABC infection.
- Known or suspected neuropathy or neuromuscular disease.
- Human immunodeficiency virus infection.
- Chronic immunosuppression due to drugs and/or underlying disease
- Bronchial obstruction or a history of post obstructive pneumonia (this does not exclude patients with pneumonia who have an underlying chronic obstructive pulmonary disease).
- 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...
- Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg
- Diagnosis of ventilator-associated tracheobronchitis.
- Inability to provide proper respiratory specimens for culture.
- Received more than 48 hours of potentially active treatment against CRABC prior to the first dose of study drug.
- Known or suspected allergy to polymyxin, rifabutin, colistin, ampicillin/sulbactam, meropenem or their excipients.
- Acute graft-versus-host disease (Grade ≥ 3).
- Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.
- 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...
- Expected survival \< 72 hours or a Do Not Resuscitate Order.
- Burns \> 40% of total body surface area.
- 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.
- 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...
- 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...
- 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...
- Abnormal QT interval corrected for heart rate by Fridericia formula (QTcF): \> 500 ms confirmed with repeat ECG.
- Stroke (ischemic or intracerebral hemorrhage) within 10 days prior to randomization or expected survival from stroke \< 28 days or Glasgow Coma Scale score 3 with no hope of improvement.
- Women who are pregnant or nursing.
- 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...
- Unable or not willing, in the opinion of the Investigator, to comply with all study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 82 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tbilisi, Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.