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A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex

RecruitingPhase 2Ages 18 Years - 99 YearsAllOmnix Medical Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • OMN6
  • Placebo
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Where

15 sites
Omnix Medical Research Site 1
Athens, Greece
Omnix Medical Research Site 2
Athens, Greece
Omnix Medical Research Site 3
Athens, Greece
Omnix Medical Research Site 4
Athens, Greece
Omnix Medical Research Site
Ioannina, Greece
Omnix Medical Research Site 1
Thessaloniki, Greece
Omnix Medical Research Site 2
Thessaloniki, Greece
Omnix Medical Research Site 3
Thessaloniki, Greece

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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