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Pneumonia, BacterialPhase 2NCT02218359

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization

A Phase 2 study testing Amikacin Fosfomycin Inhalation Solution in people with Pneumonia, Bacterial, run by Cardeas Pharma.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pneumonia, Bacterial
What is being tested?
Amikacin Fosfomycin Inhalation Solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2014to Jan 2016
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and non-pregnant, non-lactating females, ≥ 18 years and ≤ 80 years of age
  • Intubated and mechanically-ventilated
  • Presence of Gram-negative and/or Gram-positive organism(s) by culture of respiratory secretions from a sample obtained within the previous 7 days

Who cannot join

  • History of hypersensitivity to amikacin or fosfomycin.
  • Diagnosis of pneumonia, defined as presence of a new or progressive infiltrate(s) on chest radiograph (within 7 days prior to screening), as determined by the treating physician
  • Use of systemic antibiotics with efficacy against likely respiratory tract pathogens at the time of randomization
  • Severe acute respiratory distress syndrome (defined as PaO2/FiO2 ≤ 100 mmHg and diffuse infiltrates on Chest X-ray)
  • Refractory septic shock (severe sepsis plus unstable hypotension, in spite of adequate fluid resuscitation and vasopressors)
  • Evidence of significant renal impairment (serum creatinine > 4.0 mg/dL within 24 hours prior to screening) . If serum creatinine is > 2.0 mg/dL, site must be capable of performing continuous renal replacement therapy, if clinically indicated. Patients with serum creatinine > 4.0 mg/dL and being treated with continuous renal replacement therapy (continuous venous-venous hemofiltration or continuous venous-venous hemodialysis) or chronic hemodialysis are eligible
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  • Evidence of ototoxicity (history of hearing aid use prior to current hospitalization)
  • Evidence of hepatotoxicity (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3X the upper limit of normal value within 24 hours prior to screening)
  • Any of the following conditions that interfere with the assessment or interpretation of the diagnosis or response to therapy: chest trauma with loss of stability of the thoracic cage following a fracture of the sternum, ribs, or both; increased amounts of fluid in the lung cavities requiring chest tube drainage; lung cancer within the last 2 years; lung abscess(s); anatomical bronchial obstruction; suspected atypical pneumonia; chemical pneumonitis (e.g., inhalation injury); cystic fibrosis; congestive heart failure (leading to a PaO2/FiO2 ratio ≤ 100 mmHg and diffuse infiltrates on Chest X-ray)
  • Immunocompromised patients, including those with neutropenia NOT due to the current infection (absolute neutrophil count < 500/mm³), leukemia, lymphoma, human immunodeficiency virus (HIV) infection with CD4 count < 200 cells/mm3, or splenectomy; those who are early post-transplantation, are on cytotoxic chemotherapy, or are on high-dose steroids (e.g., > 40 mg of prednisone or its equivalent [> 160 mg hydrocortisone, > 32 mg methylprednisolone, > 6 mg dexamethasone, > 200 mg cortisone] daily for > 2 weeks)
  • Positive urine and/or serum beta-hCG pregnancy test (only in women of reproductive age)
  • Participating in or has participated in other investigational interventional studies (drug or device) within the last 30 days (or 5 times the half-life of the previously administered investigational compound, whichever is longer) prior to study treatment

About this study

Official title: A Randomized Double-Blind, Placebo-Controlled, Crossover to Open Label, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® AFIS Inline System in Mechanically Ventilated Patients With Gram-negative and/or Gram-positive Bacterial Colonization

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization.

Read the detailed description

The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution (AMS) and fosfomycin solution (FFS), delivered by aerosol to the lungs via the Investigational eFlow AFIS Inline System (AFIS Inline System) with tamper evident reservoir. Patients will be randomized to receive 5 days of treatment with either AFIS or placebo, followed by all patients receiving open label AFIS for five days. The primary efficacy endpoint is the change from baseline in tracheal aspirate Gram-negative and/or Gram-positive bacterial density at the end of the 5-day randomized course of study drug.

Being tested
Amikacin Fosfomycin Inhalation Solution, Aerosolized placebo
Keywords
Gram-negative pneumonia, Aerosol antibiotics, Mechanical ventilation, Amikacin, Fosfomycin, Pneumonia, Bacterial, Pneumonia, Bacterial Infections, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Anti-Bacterial Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, MRSA
Medical subject headings
Pneumonia, Bacterial, Pneumonia, Bacterial Infections, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections

What participants receive

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

  • Amikacin Fosfomycin Inhalation SolutionDrug

    Also called Amikacin Fosfomycin Inhalation System (AFIS), eFlow Inline System

    300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the AFIS Inline System

  • Aerosolized placeboDrug

    Also called eFlow Inline System

    Placebo twice daily for Days 1 -5 to be administered by aerosol using the eFlow Inline System.

  • Amikacin Fosfomycin Inhalation SolutionDrug

    Also called Amikacin Fosfomycin Inhalation System (AFIS), eFlow Inline System

    Open-label crossover for all patients Days 6-10

Study groups in NCT02218359
Study groupRoleWhat they receive
Amikacin Fosfomycin Inhalation SolutionExperimental300 mg of amikacin and 120 mg of fosfomycin to be administered by aerosol via the AFIS Inline System.
Receives: Drug: Amikacin Fosfomycin Inhalation Solution
Aerosolized PlaceboPlacebo comparatorAerosolized placebo to be administered by aerosol using the AFIS Inline System.
Receives: Drug: Aerosolized placebo; Drug: Amikacin Fosfomycin Inhalation Solution

What is being measured

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

  1. Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density

    Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density at the end of the 5-day randomized course of study drug

    Measured: 5 day randomized course of study drug

Secondary outcomes (5)

  1. Microbiological response rate in patients with multidrug resistant Gram-negative bacteria

    Microbiological response rates at Day 5 in patients whose pre-study treatment tracheal aspirate culture was positive for multidrug resistant (MDR) Gram-negative bacteria

    Measured: Day 5

  2. Eradication of bacteria

    Eradication of bacteria at Days 10, 21, and 28

    Measured: Days 10, 21, and 28

  3. Clinical worsening

    Clinical worsening (defined as requiring institution of IV antibiotics) from Day 1 through Day 28

    Measured: Day 1 - Day 28

  4. Microbiological response rates

    Microbiological response rates at Day 10 in all patients

    Measured: Day 10

  5. Microbiological response rates in patients with MRSA

    Microbiological response rates at Day 5 in patients whose pre-study treatment tracheal aspirate culture was positive for methicillin resistant Staphylococcus aureus (MRSA)

    Measured: Day 5

Timeline

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

  1. First posted18 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionJan 2016 (estimated)

Why it stopped: No Participants Enrolled

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02218359
Sponsor's protocol ID
CAP-01-103
Status last verified
Nov 2015
First submitted
14 Aug 2014
Last updated
18 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amikacin Fosfomycin Inhalation Solution in people with Pneumonia, Bacterial, run by Cardeas Pharma.

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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density (time frame: 5 day randomized course of study drug). 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 NCT02218359.

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 18 Nov 2015.

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