CompletedPhase 2

PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB

Georgia39 participantsStarted 2023-04-20

Plain-language 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

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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:
✓. 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

Exclusion criteria

✕. 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:
✕. 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.

What they're measuring

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)

Timeframe: 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)

Timeframe: 14 days

Trial details

NCT IDNCT05685615

SponsorBioVersys AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-01

View on ClinicalTrials.gov More Ventilator Associated Pneumonia trials

Who can participate

Age range18 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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:
✓. 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

Exclusion criteria

✕. 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:
✕. 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.

What they're measuring

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)

Timeframe: 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)

Timeframe: 14 days