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RecruitingPhase 2NCT06087536

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

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).

Sponsor

Omnix Medical Ltd

Enrollment

54 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Hospital-acquired Bacterial PneumoniaVentilator-associated Bacterial Pneumonia

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

DRUGOMN6

Cohort 1: 50 mg x 3/day Cohort 2: 100 mg x 3/day Cohort 3: 150 mg x 3/day 3 x 3-hour IV infusions for 1 Day of treatment concomitant with background antimicrobial treatment with meropenem plus colistin for 7 to 14 days

DRUGPlacebo

3 x 3-hour IV infusions for 1 Day of treatment concomitant with background antimicrobial treatment with meropenem plus colistin for 7 to 14 days

Locations(5)

Omnix Medical Research Site

Be’er Ya‘aqov, Israel

Omnix Medical Research Site

Holon, Israel

Omnix Medical Research Site

Petah Tikva, Israel

Omnix Medical Research Site

Ramat Gan, Israel

Omnix Medical Research Site

Rishon LeZiyyon, Israel

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NCT06087536