Hospital-acquired Bacterial PneumoniaPhase 2NCT06087536
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
A Phase 2 study testing OMN6 in people with Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia, run by Omnix Medical Ltd at 15 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- What is being tested?
- OMN6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 14 May 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
Greece9 sites, 9 recruiting
- Recruiting
Omnix Medical Research Site 1
Athens
- Recruiting
Omnix Medical Research Site 2
Athens
- Recruiting
Omnix Medical Research Site 3
Athens
- Recruiting
Omnix Medical Research Site 4
Athens
- Recruiting
Omnix Medical Research Site
Ioannina
- Recruiting
Omnix Medical Research Site 1
Thessaloniki
- Recruiting
Omnix Medical Research Site 2
Thessaloniki
- Recruiting
Omnix Medical Research Site 3
Thessaloniki
- Recruiting
Omnix Medical Research Site 4
Thessaloniki
Israel6 sites, 6 recruiting
- Recruiting
Omnix Medical Research Site
Ashdod
- Recruiting
Omnix Medical Research Site
Be’er Ya‘aqov
- Recruiting
Omnix Medical Research Site
Holon
- Recruiting
Omnix Medical Research Site
Petah Tikva
- Recruiting
Omnix Medical Research Site
Ramat Gan
- Recruiting
Omnix Medical Research Site
Rishon LeZiyyon
About this study
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).
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.
- Being tested
- OMN6, Placebo
- Keywords
- HABP VABP ABC Acinetobacter baumannii pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMN6Drug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| OMN6 treatment | Experimental | OMN6 on top of Meropenem and Colistin Receives: Drug: OMN6 |
| Placebo | Placebo comparator | Placebo on top of Meropenem and Colistin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 day
To asses the Cmax of OMN6 in patient population
Maximum Observed Plasma Concentration
Measured: 1 day
To assess the Tmax of OMN6 in patient population
Time to Cmax
Measured: 1 day
To assess the AUC of OMN6 in patient population
Area Under the Plasma Concentration-Time Curve
Measured: 1 day
To assess the t1/2 of OMN6 in patient population
Time to Half-life
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start14 May 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-acquired Bacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omnix Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087536
- Sponsor's protocol ID
- OMN6-002
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06087536
- Acronym / sponsor ID
- OMN6-002
- Keywords
- HABP VABP ABC Acinetobacter baumannii pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Omnix Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMN6 treatment | Experimental | Drug: OMN6OMN6 on top of Meropenem and Colistin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo on top of Meropenem and Colistin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMN6Cohort 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 | OMN6 treatment |
| Placebo3 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 |
Primary outcome
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
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
Time frame: 1 day
Maximum Observed Plasma Concentration
To assess the Tmax of OMN6 in patient population
Time frame: 1 day
Time to Cmax
To assess the AUC of OMN6 in patient population
Time frame: 1 day
Area Under the Plasma Concentration-Time Curve
To assess the t1/2 of OMN6 in patient population
Time frame: 1 day
Time to Half-life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- OMN6 a novel bioengineered peptide for the treatment of multidrug resistant Gram negative bacteriaLink provided by the sponsor.
- In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumanniiLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OMN6 in people with Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia, run by Omnix Medical Ltd at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Greece, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bella Shusterman (+972 2 5320871, bella@omnixmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.