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



Status:Recruiting
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2015
Contact:Medpace Recruitment Center
Email:recruitment@medpace.com
Phone:1.866.872.2349

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A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of ME1100 Inhalation Solution Plus Best Available Therapy Versus Best Available Therapy Alone in the Treatment of Mechanically Ventilated Patients With Bacterial Pneumonia

The purpose of this study is to assess the pharmacokinetic (PK) profile, the safety and the
tolerability of adjunctive therapy with ME1100 inhalation solution (arbekacin inhalation
solution) versus aerosolized placebo in mechanically ventilated patients with 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. Has been admitted to the ICU and 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
olymorphonuclear 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;

5. Has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and ≤
30 at the Screening Visit;

6. Is expected by the Investigator to require mechanical ventilation and intubation for
at least 3 days.

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 systemic antibacterial therapy for the current mechanically
ventilated bacterial pneumonia episode for > 48 hours within 72 hours of study entry
with either of the following exceptions:

1. Unequivocal clinical evidence of treatment failure of the current mechanically
ventilated bacterial pneumonia episode (eg, worsening signs and symptoms)
following ≥ 48 hours of prior systemic antimicrobial therapy; or

2. Documented isolation of an identified pathogen from blood or respiratory culture
from the current mechanically ventilated bacterial pneumonia episode that is
resistant to the prior systemic antimicrobial therapy;

3. Has been treated with any inhaled antibiotic (including inhaled aminoglycosides)
within 72 hours of study entry;

4. Has renal insufficiency at Screening as evidenced by an estimated creatinine
clearance <50 mL/min based on the Cockcroft-Gault formula;

5. Is at risk of rapidly fatal illness and death within the next 72 hours;

6. 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;

7. Has myasthenia gravis, parkinsonism, or any other progressive neuromuscular disorder;

8. Has a history of epilepsy or known seizure disorder;

9. Has a history of sensorineural hearing loss resulting from any therapy known as
ototoxic (eg, aminoglycosides, cisplatin, loop diuretics, or quinine);

10. 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;

11. Has known hypersensitivity to ME1100, aminoglycosides, or any of the specifiedBest
Available Therapy agents or their excipients.
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