Status:
RECRUITING
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Lead Sponsor:
Omnix Medical Ltd
Conditions:
Hospital-acquired Bacterial Pneumonia
Ventilator-associated Bacterial Pneumonia
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 Pneumoni...
Eligibility Criteria
Inclusion
- A signed informed consent form.
- Male or female patients 18 years or older
- A diagnosis of either a HABP or a VABP
- ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
- Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24
Exclusion
- Moderate to severe reduction of renal function
- Liver dysfunction
- Evidence of septic shock
- Acute respiratory distress syndrome.
- Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
- History of any known hypersensitivity to colistin or to carbapenems
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06087536
Start Date
February 1 2025
End Date
June 1 2026
Last Update
February 26 2025
Active Locations (4)
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1
Omnix Medical Research Site
Be’er Ya‘aqov, Israel
2
Omnix Medical Research Site
Holon, Israel
3
Omnix Medical Research Site
Petah Tikva, Israel
4
Omnix Medical Research Site
Rishon LeZiyyon, Israel