New weapon against superbug pneumonia and blood infections
NCT ID NCT07431307
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new antibiotic combination (BV100 plus other drugs) against hard-to-treat infections like pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. About 120 adults in the hospital will receive either the new combo or the best available treatment. The goal is to see if the new combo is safer and works better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 82 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 2. Male subjects or female subjects ≥ 18 and ≤ 82 years of age at the time of signing informed consent. 3. 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 4. Diagnosed with HABP, VABP or BSI 5. Acute Physiology and Chronic Health Evaluation (APACHE II) score ≤ 30, within 24 hours prior to randomization. Part B specific inclusion criteria 6. Confirmed CRABC ventriculitis or meningitis based on evidence from CSF culture collected within 72 hours prior to enrollment (as per standard of care). 7. Functioning EVD that can be used for safe and timely CSF sampling. 8. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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