RecruitingPhase 2

A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex

Israel54 participantsStarted 2026-03

Plain-language 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 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin

Timeframe: 28 day

To asses the Cmax of OMN6 in patient population

Timeframe: 1 day

To assess the Tmax of OMN6 in patient population

Timeframe: 1 day

To assess the AUC of OMN6 in patient population

Timeframe: 1 day

To assess the t1/2 of OMN6 in patient population

Timeframe: 1 day

Trial details

NCT IDNCT06087536

SponsorOmnix Medical Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Bella Shusterman

+972 2 5320871 bella@omnixmedical.com

View on ClinicalTrials.gov More Hospital-acquired Bacterial Pneumonia trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin

Timeframe: 28 day

To asses the Cmax of OMN6 in patient population

Timeframe: 1 day

To assess the Tmax of OMN6 in patient population

Timeframe: 1 day

To assess the AUC of OMN6 in patient population

Timeframe: 1 day

To assess the t1/2 of OMN6 in patient population

Timeframe: 1 day