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

NCT ID: NCT02459158

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dose of ME1100

Group Type: EXPERIMENTAL

ME1100 inhalation solution

Intervention Type: DRUG

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

High dose of ME1100

Group Type: EXPERIMENTAL

ME1100 inhalation solution

Intervention Type: DRUG

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

Interventions

ME1100 inhalation solution

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

Intervention Type: DRUG

ME1100 inhalation solution

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

Intervention Type: DRUG

Other Intervention Names

Arbekacin inhalation solution; Arbekacin inhalation solution

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meiji Seika Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meiji Study Director

Role: STUDY_DIRECTOR

Meiji Seika Pharma Co., Ltd.

Locations

Martinez, California, United States

Sacramento, California, United States

San Diego, California, United States

Aurora, Colorado, United States

Jacksonville, Florida, United States

Hazard, Kentucky, United States

Worcester, Massachusetts, United States

Kalamazoo, Michigan, United States

Buffalo, New York, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Lima, Ohio, United States

Toledo, Ohio, United States

Houston, Texas, United States

Countries

United States

Other Identifiers

ME1100-CL-103

Identifier Type: -

Identifier Source: org_study_id