A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorOmnix Medical Ltd
About this trial
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
Qualifiers
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
Disqualifiers
Moderate to severe reduction of renal function
Liver dysfunction
Evidence of septic shock
Acute respiratory distress syndrome.
Trial design
Treatments tested in this trial
- OMN6
- Placebo
Treatment groups
54 Participants
are divided into 2 treatment groupsLocations
6Omnix Medical Research Site Ashdod Israel
Omnix Medical Research Site Be’er Ya‘aqov Israel
Omnix Medical Research Site Holon Israel
Omnix Medical Research Site Petah Tikva Israel
Sponsors and collaborators
Omnix Medical Ltd
Lead sponsor
Source ClinicalTrials.gov