Actively Recruiting
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Led by Omnix Medical Ltd · Updated on 2026-03-11
54
Participants Needed
5
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.
CONDITIONS
Official Title
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Male or female patients 18 years or older
- Diagnosis of hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia
- Suspected ABC infection of the lower respiratory tract based on positive rapid respiratory specimen testing
- Women of childbearing potential must have a negative pregnancy test before randomization
- APACHE II score between 10 and 24
You will not qualify if you...
- Moderate to severe reduction of renal function
- Liver dysfunction
- Evidence of septic shock
- Acute respiratory distress syndrome
- Immunosuppressed patients due to drugs or medical condition
- Known hypersensitivity to colistin or carbapenems
- Any condition compromising patient safety or study data quality as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Omnix Medical Research Site
Be’er Ya‘aqov, Israel
Actively Recruiting
2
Omnix Medical Research Site
Holon, Israel
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3
Omnix Medical Research Site
Petah Tikva, Israel
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4
Omnix Medical Research Site
Ramat Gan, Israel
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5
Omnix Medical Research Site
Rishon LeZiyyon, Israel
Actively Recruiting
Research Team
B
Bella Shusterman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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