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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hospital-acquired Bacterial Pneumonia Ventilator-associated Bacterial Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OMN6 treatment

OMN6 on top of Meropenem and Colistin

Group Type EXPERIMENTAL

OMN6

Intervention Type DRUG

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

Placebo

Placebo on top of Meropenem and Colistin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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OMN6

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No