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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMN6 treatment | Experimental | OMN6 on top of Meropenem and Colistin |
|
| Placebo | Placebo Comparator | Placebo on top of Meropenem and Colistin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To asses the Cmax of OMN6 in patient population | Maximum Observed Plasma Concentration | 1 day |
| To assess the Tmax of OMN6 in patient population | Time to Cmax | 1 day |
| To assess the AUC of OMN6 in patient population | Area Under the Plasma Concentration-Time Curve | 1 day |
| To assess the t1/2 of OMN6 in patient population | Time to Half-life | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bella Shusterman | Contact | +972 2 5320871 | bella@omnixmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omnix Medical Research Site | Recruiting | Ashdod | Israel | |||
| Omnix Medical Research Site |
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| Label | URL |
|---|---|
| OMN6 a novel bioengineered peptide for the treatment of multidrug resistant Gram negative bacteria | View source |
| In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii | View source |
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| 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 |
|
| Recruiting |
| Be’er Ya‘aqov |
| Israel |
| Omnix Medical Research Site | Recruiting | Holon | Israel |
| Omnix Medical Research Site | Recruiting | Petah Tikva | Israel |
| Omnix Medical Research Site | Recruiting | Ramat Gan | Israel |
| Omnix Medical Research Site | Recruiting | Rishon LeZiyyon | Israel |