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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia

Intervention / Treatment
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* Drug: OMN6
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMN6 treatment<br>OMN6 on top of Meropenem and Colistin | Drug: OMN6<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo on top of Meropenem and Colistin | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HABP VABP ABC Acinetobacter baumannii pneumonia