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โ† Trials
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MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia

RecruitingPhase 1Ages 19 Years - anyAllMicrobiotiX Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. * Adequate organ function as defined by hematological, hepatic, and renal laboratory parameters . Exclusion Criteria: * Persistent septic shock or hemodynamically unstable condition. * Active pulmonary tuberculosis or non-bacterial pneumonia. * Significant pleural effusion or lung abscess requiring therapeutic drainage. * Clinically significant cardiovascular, hepatic, or renal impairment . * Immunocompromised status or hematological malignancies. * Known hypersensitivity to bacteriophages, study components, or concomitant antibiotics. * Participation in another clinical trial within 30 days prior to screening. * Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study.
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What it tests

  • MP101
  • Antibiotics
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Where

1 site
Severance Hospital
Seoul, South Korea
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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