A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
In brief
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.
Key facts
- Study ID
- NCT06087536
- Run by
- Omnix Medical Ltd
- People needed
- 54
- Starts
- 2026-05-14
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Omnix Medical Research Site — Ashdod, Israel (enrolling)
- Omnix Medical Research Site — Be’er Ya‘aqov, Israel (enrolling)
- Omnix Medical Research Site — Holon, Israel (enrolling)
- Omnix Medical Research Site — Petah Tikva, Israel (enrolling)
- Omnix Medical Research Site — Ramat Gan, Israel (enrolling)
- Omnix Medical Research Site — Rishon LeZiyyon, Israel (enrolling)
Full record on ClinicalTrials.gov
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