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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06087536
Other study ID # OMN6-002
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date January 2024
Est. completion date June 2026

Study information

Verified date October 2023
Source Omnix Medical Ltd
Contact Bella Shusterman
Phone +972 2 5320871
Email bella@omnixmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OMN6
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
Placebo
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Omnix Medical Ltd

Outcome

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
See also
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Completed NCT03583333 - Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016) Phase 3
Completed NCT02420366 - Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Completed NCT01292031 - Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB) Phase 3
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Completed NCT04107363 - Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia N/A
Not yet recruiting NCT01865266 - The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia Phase 2/Phase 3
Withdrawn NCT03006679 - A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia Phase 3