NCT06087536 A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
| NCT ID | NCT06087536 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Omnix Medical Ltd |
| Condition | Hospital-acquired Bacterial Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 54 participants in total. It began in 2026-05-14 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06087536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hospital-acquired Bacterial Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06087536 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06087536 currently recruiting?
Yes, NCT06087536 is actively recruiting participants. Contact the research team at bella@omnixmedical.com for enrollment information.
Where is the NCT06087536 trial being conducted?
This trial is being conducted at Ashdod, Israel, Be’er Ya‘aqov, Israel, Holon, Israel, Petah Tikva, Israel and 2 additional locations.
Who is sponsoring the NCT06087536 clinical trial?
NCT06087536 is sponsored by Omnix Medical Ltd. The trial plans to enroll 54 participants.