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A prospective, multinational, multicenter, randomized, sequential, double-blind, placebo-controlled, phase 2a clinical study to assess the safety and pharmacokinetics (PK) of OMN6 in hospital-acquired bacterial pneumonia (HABP) or ventilated-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524200-29-00
Enrollment
24
Registered
2026-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital-acquired bacterial pneumonia or ventilated-associated bacterial pneumonia caused by Acinetobacter baumannii complex.

Brief summary

Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings, vital signs and ECGs change from baseline and 28-day ACM., OMN6 PK parameters.

Detailed description

Proportion of participants with clinical cure, clinical improvement, combined clinical cure plus clinical improvement.

Interventions

DRUGSALINE
DRUGOMN6

Sponsors

Omnix Medical Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings, vital signs and ECGs change from baseline and 28-day ACM., OMN6 PK parameters.

Secondary

MeasureTime frame
Proportion of participants with clinical cure, clinical improvement, combined clinical cure plus clinical improvement.

Outcome results

None listed

Source: EU CTIS · Data processed: May 8, 2026