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

NCT02459158 | Completed Phase 1

• 1 other identifier: ME1100-CL-103
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 14

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.

Conditions

Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of participants with adverse events

  Screening through 14 days after the end of treatment

Study Arms (2)

Low dose of ME1100

EXPERIMENTAL

Drug: ME1100 inhalation solution

High dose of ME1100

EXPERIMENTAL

Drug: ME1100 inhalation solution

Interventions

ME1100 inhalation solution DRUG

Low dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system

Also known as: Arbekacin inhalation solution

Low dose of ME1100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a hospitalized male or female, ≥ 18 years of age at the Screening Visit;
• Is on mechanical ventilation;
• 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;

You may not qualify if:

• Has a requirement of inhaled non-study antibiotic;
• Has been treated with any inhaled antibiotic (including inhaled aminoglycosides) within 72 hours of study entry;
• Has renal insufficiency at Screening as evidenced by an estimated creatinine clearance \<50 mL/min based on the Cockcroft-Gault formula;
• Is at risk of rapidly fatal illness and death within the next 72 hours;
• 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;
• Has myasthenia gravis, parkinsonism, or any other progressive neuromuscular disorder;
• Has a history of epilepsy or known seizure disorder;
• Has a history of sensorineural hearing loss resulting from any therapy known as ototoxic (eg, aminoglycosides, cisplatin, loop diuretics, or quinine);
• 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
• Has known hypersensitivity to ME1100, aminoglycosides, or any of the specified Best Available Therapy agents or their excipients.

Sponsors & Collaborators

• Meiji Seika Pharma Co., Ltd.: lead

Study Sites (14)

Unknown Facility

Martinez, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Hazard, Kentucky, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Kalamazoo, Michigan, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Lima, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meiji Study Director

  Meiji Seika Pharma Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: September 1, 2015
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: July 5, 2017

Record last verified: 2016-11

Locations

US (14)