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

Last updated: February 24, 2025
Sponsor: Omnix Medical Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Pneumonia

Treatment

OMN6

Placebo

Clinical Study ID

NCT06087536
OMN6-002
  • Ages 18-99
  • All Genders

Study 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 Criteria

Inclusion

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 rapidtesting of respiratory specimens

  5. Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgicallysterilized) must have a negative highly sensitive urine or serum pregnancy testbefore randomization.

  6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

Exclusion

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 medicalcondition).

  6. History of any known hypersensitivity to colistin or to carbapenems

  7. Any condition or circumstance that, in the opinion of the investigator, wouldcompromise the safety of the patient or the quality of the study data

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: OMN6
Phase: 2
Study Start date:
February 01, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Omnix Medical Research Site

    Be'er Ya'akov,
    Israel

    Active - Recruiting

  • Omnix Medical Research Site

    Holon,
    Israel

    Active - Recruiting

  • Omnix Medical Research Site

    Petah Tikva,
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva,
    Israel

    Active - Recruiting

  • Omnix Medical Research Site

    Rishon LeTsiyon,
    Israel

    Active - Recruiting

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