Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
Conditions
Keywords
HABP VABP ABC Acinetobacter baumannii pneumonia
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.
Interventions
DRUGOMN6
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
DRUGPlacebo
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
Sponsors
Omnix Medical Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin | 28 day | 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 | 1 day | Maximum Observed Plasma Concentration |
| To assess the Tmax of OMN6 in patient population | 1 day | Time to Cmax |
| To assess the AUC of OMN6 in patient population | 1 day | Area Under the Plasma Concentration-Time Curve |
| To assess the t1/2 of OMN6 in patient population | 1 day | Time to Half-life |
Countries
Israel
Contacts
CONTACTBella Shusterman
Outcome results
None listed