Ventilator-associated Bacterial Pneumonia Clinical Trial
Official 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).
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.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | June 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Omnix Medical Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin | Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline. | 28 day | |
Primary | To asses the Cmax of OMN6 in patient population | Maximum Observed Plasma Concentration | 1 day | |
Primary | To assess the Tmax of OMN6 in patient population | Time to Cmax | 1 day | |
Primary | To assess the AUC of OMN6 in patient population | Area Under the Plasma Concentration-Time Curve | 1 day | |
Primary | To assess the t1/2 of OMN6 in patient population | Time to Half-life | 1 day |
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