MP101 plus antibiotics in adults with acute Pseudomonas pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-dose phase 1 trial in adults with acute Pseudomonas aeruginosa pneumonia conducted at multiple sites in Korea. Participants are assigned to low-dose or high-dose MP101 or placebo, in addition to standard antibiotics, with inpatient observation through Day 8 and follow-up visits on Days 15 and 29. The study will assess safety, pharmacokinetics and pharmacodynamics in blood and sputum, antibacterial activity against P. aeruginosa, and exploratory inflammatory and clinical outcomes. Eligibility requires confirmed PA infection with a susceptible isolate to MP101 and adequate organ function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Severance Hospital
  Seoul, Seodaemun-gu, South Korea Recruiting

Study contacts

• Principal investigator: Jun Yong Choi — Severance Hospital
• Study coordinator: Sangmin Lee, Director
• Email: smlee@microbiotix.net
• Phone: 82-10-2807-7489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.