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

NCT ID: NCT02218359

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Amikacin Fosfomycin Inhalation Solution

300 mg of amikacin and 120 mg of fosfomycin to be administered by aerosol via the AFIS Inline System.

Group Type EXPERIMENTAL

Amikacin Fosfomycin Inhalation Solution

Intervention Type DRUG

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

Amikacin Fosfomycin Inhalation Solution

Intervention Type DRUG

Open-label crossover for all patients Days 6-10

Aerosolized Placebo

Aerosolized placebo to be administered by aerosol using the AFIS Inline System.

Group Type PLACEBO_COMPARATOR

Aerosolized placebo

Intervention Type DRUG

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

Amikacin Fosfomycin Inhalation Solution

Intervention Type DRUG

Open-label crossover for all patients Days 6-10

Interventions

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Amikacin Fosfomycin Inhalation Solution

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

Intervention Type DRUG

Aerosolized placebo

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

Intervention Type DRUG

Amikacin Fosfomycin Inhalation Solution

Open-label crossover for all patients Days 6-10

Intervention Type DRUG

Other Intervention Names

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Amikacin Fosfomycin Inhalation System (AFIS) eFlow Inline System eFlow Inline System Amikacin Fosfomycin Inhalation System (AFIS) eFlow Inline System

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardeas Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Montgomery, M.D.

Role: STUDY_DIRECTOR

Cardeas Pharma

Related Links

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http://www.nlm.nih.gov/medlineplus/antibiotics.html

MedlinePlus related topics: Antibiotics

http://www.nlm.nih.gov/medlineplus/pneumonia.html

MedlinePlus related topics: Pneumonia

http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0037517285&QV1=AMIKACIN

Drug Information available for amikacin

http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0023155024&QV1=FOSFOMYCIN

Drug information available for fosfomycin

http://www.clinicaltrials.gov/ct2/info/fdalinks

U.S. FDA Resources

Other Identifiers

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CAP-01-103

Identifier Type: -

Identifier Source: org_study_id