A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia

Inclusion Criteria: Participants must meet all of the following inclusion criteria in order to be eligible for the study: 1. Is a hospitalized male or female, ≥ 18 years of age at the Screening Visit; 2. Is on mechanical ventilation; 3. Has a known or suspected mechanically ventilated bacterial pneumonia with at least 1 of the following: * Fever (\> 38.5ﾟC or \> 101.3ﾟF); * Hypothermia (≤ 35.0ﾟC or ≤ 95.0ﾟF); * Leukopenia (≤ 4500 cells/mm3); * Leukocytosis (≤ 10000 cells/mm3); * White blood cell count with left shift defined as \> 15% immature polymorphonuclear leukocytes (bands) on peripheral blood smear; or * Procalcitonin \> 0.25 µg/mL; Plus at least 2 of the following: * Respiratory failure requiring mechanical ventilation; * New onset of expectorated or suctioned purulent sputum production or respiratory secretions, or a change in the character of sputum; * Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation; * Dyspnea, tachypnea, or signs of respiratory distress as evidenced by an increase in respiratory support or oxygen requirement, particularly if any or all of these are progressive in nature; or * Hypoxemia by pulse oximetry or arterial blood gas requiring an increase in supplemental oxygen; 4. Has a chest X-ray with a new consolidation consistent with pneumonia or significant worsening of previous findings consistent with pneumonia; and 5. Has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and ≤ 30 at the Screening Visit. Exclusion Criteria: Participants who meet any of the following exclusion criteria will not be enrolled in the study: 1. Has a requirement of inhaled non-study antibiotic; 2. Has been treated with any inhaled antibiotic (including inhaled aminoglycosides) within 72 hours of study entry; 3. Has renal insufficiency at Screening as evidenced by an estimated creatinine clearance \<50 mL/min based on the Cockcroft-Gault formula; 4. Is at risk of rapidly fatal illness and death within the next 72 hours; 5. Is a pregnant or nursing female. Females of childbearing potential must have a serum pregnancy test prior to enrollment. If results of the serum pregnancy test are not available prior to the Day 1 Treatment Visit, the patients may be enrolled on the basis of a negative urine pregnancy test; however, the results of the serum pregnancy test must still be obtained. If either test is positive, the patients must be excluded; 6. Has myasthenia gravis, parkinsonism, or any other progressive neuromuscular disorder; 7. Has a history of epilepsy or known seizure disorder; 8. Has a history of sensorineural hearing loss resulting from any therapy known as ototoxic (eg, aminoglycosides, cisplatin, loop diuretics, or quinine); 9. Has received any investigational medication in the last 30 days (or 5 half-lives of the investigational medication, whichever is longer) prior to the Screening Visit; or 10. Has known hypersensitivity to ME1100, aminoglycosides, or any of the specified Best Available Therapy agents or their excipients.