A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OMN6, Placebo.
- Who it may be relevant to
- Registry conditions: Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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).
Overview
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
- 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 - Drug 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
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 [Time frame: 28 day]
- To asses the Cmax of OMN6 in patient population [Time frame: 1 day]
- To assess the Tmax of OMN6 in patient population [Time frame: 1 day]
- To assess the AUC of OMN6 in patient population [Time frame: 1 day]
- To assess the t1/2 of OMN6 in patient population [Time frame: 1 day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Israel · 6 centers
- Omnix Medical Research Site — Ashdod
- Omnix Medical Research Site — Be’er Ya‘aqov
- Omnix Medical Research Site — Holon
- Omnix Medical Research Site — Petah Tikva
- Omnix Medical Research Site — Ramat Gan
- Omnix Medical Research Site — Rishon LeZiyyon
Identifiers
NCT: NCT06087536 · OMN6-002