Pneumonia, Bacterial
Conditions
Brief summary
This study is a randomized, open-label phase I study. The primary objective of this study is to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and tolerability of ME1100.
Interventions
Low dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
Sponsors
Meiji Seika Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arbekacin concentrations in respiratory fluids collected via bronchoalveolar lavage (BAL) for epithelial lining fluid (ELF) | Day 3 |
| Plasma arbekacin concentrations | Day 1 to Day 5 |
| Urinary elimination of arbekacin | Day 2 |
| Arbekacin concentrations in tracheal aspirate | Day 2 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Screening through 14 days after the end of treatment |
Countries
United States
Outcome results
None listed