Pneumonia, BacterialPhase 1NCT02459158

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

A Phase 1 study testing ME1100 inhalation solution in people with Pneumonia, Bacterial, run by Meiji Seika Pharma Co., Ltd. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pneumonia, Bacterial
What is being tested?: ME1100 inhalation solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 14 sitesUnited States
Study dates: Sep 2015to 22 Mar 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet all of the following inclusion criteria in order to be eligible for the study:
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);

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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;
Has a chest X-ray with a new consolidation consistent with pneumonia or significant worsening of previous findings consistent with pneumonia; and
Has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and ≤ 30 at the Screening Visit.

Who cannot join

Participants who meet any of the following exclusion criteria will not be enrolled in the study:
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;

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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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Aurora, Colorado
Study site
Buffalo, New York
Study site
Cincinnati, Ohio
Study site
Greensboro, North Carolina
Study site
Hazard, Kentucky
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kalamazoo, Michigan
Study site
Lima, Ohio
Study site
Martinez, California
Study site
Sacramento, California
Study site
San Diego, California
Study site
Toledo, Ohio
Study site
Worcester, Massachusetts

Other trials in United States

About this study

Official title: A Randomized, Open-Label Phase 1b Study of ME1100 Inhalation Solution Plus Best Available Therapy in the Treatment of Mechanically Ventilated Subjects With Bacterial Pneumonia

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
Being tested: ME1100 inhalation solution
Medical subject headings: Pneumonia, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ME1100 inhalation solutionDrug
Also called Arbekacin inhalation solution
Low dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
ME1100 inhalation solutionDrug
Also called Arbekacin inhalation solution
High dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system

Study groups in NCT02459158
Study group	Role	What they receive
Low dose of ME1100	Experimental	Not described Receives: Drug: ME1100 inhalation solution
High dose of ME1100	Experimental	Not described Receives: Drug: ME1100 inhalation solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Arbekacin concentrations in respiratory fluids collected via bronchoalveolar lavage (BAL) for epithelial lining fluid (ELF)
Measured: Day 3
Plasma arbekacin concentrations
Measured: Day 1 to Day 5
Urinary elimination of arbekacin
Measured: Day 2
Arbekacin concentrations in tracheal aspirate
Measured: Day 2

Secondary outcomes (1)

Number of participants with adverse events
Measured: Screening through 14 days after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201522 Mar 2017

First posted1 Jun 2015 (estimated)
Study startSep 2015
Primary completion22 Mar 2017
Study completion22 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02459158
Sponsor's protocol ID: ME1100-CL-103
Status last verified: Nov 2016
First submitted: 28 May 2015
Last updated: 5 Jul 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label Phase 1b Study of ME1100 Inhalation Solution Plus Best Available Therapy in the Treatment of Mechanically Ventilated Subjects With Bacterial Pneumonia
ClinicalTrials.gov ID: NCT02459158
Acronym / sponsor ID: ME1100-CL-103
Conditions: Pneumonia, Bacterial
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: 22 Mar 2017 (actual)
Study completion: 22 Mar 2017 (actual)
First posted: 1 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low dose of ME1100	Experimental	Drug: ME1100 inhalation solution
High dose of ME1100	Experimental	Drug: ME1100 inhalation solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Participants must meet all of the following inclusion criteria in order to be eligible for the study:
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:
Has a chest X-ray with a new consolidation consistent with pneumonia or significant worsening of previous findings consistent with pneumonia; and

Key exclusion criteria (11 listed)

Participants who meet any of the following exclusion criteria will not be enrolled in the study:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ME1100 inhalation solutionAlso: Arbekacin inhalation solutionLow dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system	Drug	Low dose of ME1100
ME1100 inhalation solutionAlso: Arbekacin inhalation solutionHigh dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system	Drug	High dose of ME1100

Primary outcome

Arbekacin concentrations in respiratory fluids collected via bronchoalveolar lavage (BAL) for epithelial lining fluid (ELF)
Time frame: Day 3
Plasma arbekacin concentrations
Time frame: Day 1 to Day 5
Urinary elimination of arbekacin
Time frame: Day 2
Arbekacin concentrations in tracheal aspirate
Time frame: Day 2

1 secondary outcome

Number of participants with adverse events
Time frame: Screening through 14 days after the end of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meiji Study Director study director

Meiji Seika Pharma Co., Ltd.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ME1100 inhalation solution in people with Pneumonia, Bacterial, run by Meiji Seika Pharma Co., Ltd. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arbekacin concentrations in respiratory fluids collected via bronchoalveolar lavage (BAL) for epithelial lining fluid (ELF) (time frame: Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.