Health Trials

About this trial

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MP101 administered in addition to standard antibiotic therapy in adult patients with acute Pseudomonas aeruginosa pneumonia. The study will also assess the pharmacokinetic and pharmacodynamic characteristics of MP101 and its antibacterial activity, including changes in P. aeruginosa burden in sputum and changes in susceptibility to MP101 and concomitant antibiotics.

Eligibility criteria

Qualifiers

Subjects aged 19 years or older.

Clinical diagnosis of acute pneumonia with radiologic evidence of pulmonary infiltrates.

Confirmed Pseudomonas aeruginosa (PA) infection via valid respiratory specimens.

PA isolate demonstrates susceptibility to MP101 and non-susceptibility to current antibiotic therapy.

Disqualifiers

Persistent septic shock or hemodynamically unstable condition.

Active pulmonary tuberculosis or suspected non-bacterial pneumonia.

Significant pleural effusion or lung abscess requiring therapeutic drainage.

Clinically significant cardiovascular, hepatic, or renal impairment .

Trial design

Treatments tested in this trial

  • MP101
  • Antibiotics

Treatment groups

18 Participants
are divided into 3 treatment groups

Locations

1
Severance Hospital03722, SeoulSeodaemun-gu, South Korea

Sponsors and collaborators

MicrobiotiX Co., Ltd

Lead sponsor

Source ClinicalTrials.gov