Back to resultsA Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Primary Purpose
Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OMN6
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hospital-acquired Bacterial Pneumonia focused on measuring HABP VABP ABC Acinetobacter baumannii pneumonia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OMN6 treatment
Placebo
Arm Description
OMN6 on top of Meropenem and Colistin
Placebo on top of Meropenem and Colistin
Outcomes
Primary Outcome Measures
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.
To asses the Cmax of OMN6 in patient population
Maximum Observed Plasma Concentration
To assess the Tmax of OMN6 in patient population
Time to Cmax
To assess the AUC of OMN6 in patient population
Area Under the Plasma Concentration-Time Curve
To assess the t1/2 of OMN6 in patient population
Time to Half-life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06087536
Brief Title
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
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).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omnix Medical Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
Keywords
HABP VABP ABC Acinetobacter baumannii pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OMN6 treatment
Arm Type
Experimental
Arm Description
OMN6 on top of Meropenem and Colistin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo on top of Meropenem and Colistin
Intervention Type
Drug
Intervention Name(s)
OMN6
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin
Description
Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.
Time Frame
28 day
Title
To asses the Cmax of OMN6 in patient population
Description
Maximum Observed Plasma Concentration
Time Frame
1 day
Title
To assess the Tmax of OMN6 in patient population
Description
Time to Cmax
Time Frame
1 day
Title
To assess the AUC of OMN6 in patient population
Description
Area Under the Plasma Concentration-Time Curve
Time Frame
1 day
Title
To assess the t1/2 of OMN6 in patient population
Description
Time to Half-life
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bella Shusterman
Phone
+972 2 5320871
Email
bella@omnixmedical.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988117/
Description
OMN6 a novel bioengineered peptide for the treatment of multidrug resistant Gram negative bacteria
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9494975/
Description
In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii
Learn more about this trial
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
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