Clinical Trials List
Protocol NumberBV100-012
NCT Number(ClinicalTrials.gov Identfier)NCT07431307
Not yet recruiting
2026-06-01 - 2028-12-31
Phase II
Not yet recruiting1
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 cefiderocol in patients with confirmed CRABC ventriculitis or meningitis.
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Sponsor
TAIWAN TIGERMED CONSULTING CO., LTD
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/14
Investigators and Locations
Co-Principal Investigator
- Shih-Chi Ku 無
- Wang-Huei Sheng 無
- Szu-Min Hsieh 無
- Un-in Wu 無
- Jann-Tay Wang 無
- 陳抱宇 無
- 錢穎群 無
- 阮聖元 無
- 黃怡嘉 無
- 黃于珊 無
- 鄭琬豑 無
Co-Principal Investigator
- Ho Mao-Wang 無
- 蘇浤傑 無
Co-Principal Investigator
- Chun-Yu Lin 無
- Yi-Chang Liu 無
- Tun-Chieh Chen 無
- Chau-Chyun Sheu 無
- Chung-Hao Huang 無
- Shih-Feng Cho 無
- Wei-An Chang 無
- Ming-Ju Tsai 無
- Shang-Yi Lin 無
- 張雅婷 無
- Chun-Yuan Lee 無
- Tsung-Jang Yeh 無
- 呂其融 無
- 梁智瑋 無
Co-Principal Investigator
- Jia-Yih Feng 無
- Su-Jung Chen 無
- 陳伯亮 無
- 江東鴻 無
Principal Investigator
Ching-Tai Huang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Ventilator Associated Bacterial Pneumonia (VABP) Hospital Acquired Bacterial Pneumonia (HABP) Blood Stream Infection Meningitis, Bacterial Ventriculitis, Infectious
Objectives
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.
Test Drug
Aztreonam
BV100
FETROJA
Polymyxin B
Zavicefta
BV100
FETROJA
Polymyxin B
Zavicefta
Active Ingredient
POLYMYXIN B SULFATE
ceftazidime/avibactam
rifabutin
aztreonam
Cefiderocol
ceftazidime/avibactam
rifabutin
aztreonam
Cefiderocol
Dosage Form
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Solution for intravenous infusion
Dosage
500,000 units
2g/0.5g
300mg/0.9mL
2g
1g
2g/0.5g
300mg/0.9mL
2g
1g
Endpoints
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. 30 days
Inclution 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
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
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
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
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
Exclusion Criteria
. 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.
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.
The Estimated Number of Participants
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Taiwan
54 participants
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Global
151 participants
