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NCT Number: NCT06087536

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

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.

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Key information

Conditions

Hospital-acquired Bacterial Pneumonia Ventilator-associated Bacterial Pneumonia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Omnix Medical Research Site, Ashdod, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMN6

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 28 day

    Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.

  2. To asses the Cmax of OMN6 in patient population

    Time frame: 1 day

    Maximum Observed Plasma Concentration

  3. To assess the Tmax of OMN6 in patient population

    Time frame: 1 day

    Time to Cmax

  4. To assess the AUC of OMN6 in patient population

    Time frame: 1 day

    Area Under the Plasma Concentration-Time Curve

  5. To assess the t1/2 of OMN6 in patient population

    Time frame: 1 day

    Time to Half-life

Study contacts

Contact information is provided by the study sponsor or research team.

Bella Shusterman

CONTACT

[email protected]

+972 2 5320871

Sponsors and collaborators

Lead sponsor

Omnix Medical Ltd

Industry

Registry information

Official study title

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).

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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