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

Phase 2

Recruiting

• Conditions: Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia
• Interventions: Drug: OMN6; Drug: Placebo

• Registration Number: NCT06087536
• Lead Sponsor: Omnix Medical Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-17
• Status Verified: 2025-02
• Study Start: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OMN6 treatment	OMN6	OMN6 on top of Meropenem and Colistin
Placebo	Placebo	Placebo on top of Meropenem and Colistin

Primary Outcome Measures

Name	Time	Method
To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin	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.
To asses the Cmax of OMN6 in patient population	1 day	Maximum Observed Plasma Concentration
To assess the t1/2 of OMN6 in patient population	1 day	Time to Half-life
To assess the Tmax of OMN6 in patient population	1 day	Time to Cmax
To assess the AUC of OMN6 in patient population	1 day	Area Under the Plasma Concentration-Time Curve

Trial Locations

Locations (1)

Omnix Medical Research Site; 🇮🇱 Rishon LeTsiyon, Israel