Assessing the safety and effectiveness of OMN6 for pneumonia caused by Acinetobacter baumannii

A Prospective, Multinational, Multicenter, Randomized, Sequential, Double-blind, Placebo-controlled, Phase 2a Clinical Trial to Assess the Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (ABC).

This study is testing a new drug called OMN6 to see if it can safely help people with pneumonia caused by a specific bacteria called Acinetobacter baumannii.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Omnix Medical Ltd (Industry-sponsored)
• Locations: 5 sites (Be’er Ya‘aqov and 4 other locations)
• Trial ID: NCT06087536 on ClinicalTrials.gov

What this trial studies

This phase 2a clinical trial evaluates the safety, tolerability, and pharmacokinetics of OMN6 in patients suffering from hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii. The study is designed as a multinational, multicenter, double-blind, randomized, placebo-controlled trial, which aims to identify safe and effective doses of OMN6. Participants will be monitored for their response to the treatment and any adverse effects, contributing to a better understanding of the drug's profile in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with HABP or VABP caused by Acinetobacter baumannii.

Not a fit: Patients with moderate to severe renal dysfunction, liver dysfunction, or those who are immunosuppressed may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from severe pneumonia caused by resistant bacteria.

How similar studies have performed: While there have been studies on treatments for bacterial pneumonia, the specific approach of using OMN6 for Acinetobacter baumannii is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. A signed informed consent form.
2. Male or female patients 18 years or older
3. A diagnosis of either a HABP or a VABP
4. ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
5. 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.
6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

Exclusion Criteria:

1. Moderate to severe reduction of renal function
2. Liver dysfunction
3. Evidence of septic shock
4. Acute respiratory distress syndrome.
5. Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
6. History of any known hypersensitivity to colistin or to carbapenems
7. 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 this trial is running

Be’er Ya‘aqov and 4 other locations

• Omnix Medical Research Site — Be’er Ya‘aqov, Israel (Recruiting)
• Omnix Medical Research Site — Holon, Israel (Recruiting)
• Omnix Medical Research Site — Petah Tikva, Israel (Recruiting)
• Omnix Medical Research Site — Ramat Gan, Israel (Recruiting)
• Omnix Medical Research Site — Rishon LeZiyyon, Israel (Recruiting)

Study contacts

• Study coordinator: Bella Shusterman

Conditions Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; HABP VABP ABC Acinetobacter baumannii pneumonia