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).
Overview
- Phase
- Phase 2
- Intervention
- OMN6
- Conditions
- Hospital-acquired Bacterial Pneumonia
- Sponsor
- Omnix Medical Ltd
- Enrollment
- 54
- Locations
- 5
- Primary Endpoint
- To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
OMN6 treatment
OMN6 on top of Meropenem and Colistin
Intervention: OMN6
Placebo
Placebo on top of Meropenem and Colistin
Intervention: Placebo
Outcomes
Primary Outcomes
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.
To asses the Cmax of OMN6 in patient population
Time Frame: 1 day
Maximum Observed Plasma Concentration
To assess the t1/2 of OMN6 in patient population
Time Frame: 1 day
Time to Half-life
To assess the Tmax of OMN6 in patient population
Time Frame: 1 day
Time to Cmax
To assess the AUC of OMN6 in patient population
Time Frame: 1 day
Area Under the Plasma Concentration-Time Curve