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

ConditionsHospital-acquired Bacterial PneumoniaVentilator-associated Bacterial Pneumonia
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • OMN6

    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

    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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: OMN6 treatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin

Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.

Time frame
28 day
2

To asses the Cmax of OMN6 in patient population

Maximum Observed Plasma Concentration

Time frame
1 day
3

To assess the Tmax of OMN6 in patient population

Time to Cmax

Time frame
1 day
4

To assess the AUC of OMN6 in patient population

Area Under the Plasma Concentration-Time Curve

Time frame
1 day

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Omnix Medical Ltd

Lead sponsor

Source ClinicalTrials.gov
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