Assessing the safety and effectiveness of OMN6 for pneumonia caused by Acinetobacter baumannii

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2a clinical trial evaluates the safety, tolerability, and pharmacokinetics of OMN6 in patients suffering from hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii. The study is designed as a multinational, multicenter, double-blind, randomized, placebo-controlled trial, which aims to identify safe and effective doses of OMN6. Participants will be monitored for their response to the treatment and any adverse effects, contributing to a better understanding of the drug's profile in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Omnix Medical Research Site 1
  Athens, Greece Recruiting
• Omnix Medical Research Site 2
  Athens, Greece Recruiting
• Omnix Medical Research Site 3
  Athens, Greece Recruiting
• Omnix Medical Research Site 4
  Athens, Greece Recruiting
• Omnix Medical Research Site
  Ioannina, Greece Recruiting
• Omnix Medical Research Site 1
  Thessaloniki, Greece Recruiting

Study contacts

• Study coordinator: Bella Shusterman
• Email: bella@omnixmedical.com
• Phone: +972 2 5320871

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.