Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

This study has been completed.
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01021436
First received: November 25, 2009
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated

Condition Intervention Phase
Pneumonia
Drug: Amikacin inhalation solution (BAY41-6551)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- Ventilated Patients With Nosocomial Pneumonia

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cmax [ Time Frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose ] [ Designated as safety issue: No ]
    Maximum serum amikacin concentration observed from time 0 to 12 h

  • Tmax [ Time Frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose ] [ Designated as safety issue: No ]
    Time that Cmax occurred

  • AUC0-12h [ Time Frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose ] [ Designated as safety issue: No ]
    Area under the serum amikacin concentration vs time curve from time 0 to 12 h

  • Xu0-12h [ Time Frame: On Day 3 at the start of dose and up to 12 h after both first and second dose ] [ Designated as safety issue: No ]
    Amount of amikacin excreted in urine from 0 to 12 h after dosing

  • Xu12-24h [ Time Frame: On Day 3 at the start of dose and up to 12 h after both first and second dose ] [ Designated as safety issue: No ]
    Amount of amikacin excreted in urine from 12 to 24 h after dosing

  • Xu0-24h [ Time Frame: On Day 3 at the start of dose and up to 12 h after both first and second dose ] [ Designated as safety issue: No ]
    Amount of amikacin excreted in urine from 0 to 24 h after dosing

  • Tracheal aspirate [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Epithelial lining fluid (ELF) concentration [ Time Frame: Approximately 15-30 min after completion of the morning dose of study medication on Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: March 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amikacin inhalation solution
Subjects received 125 mg/mL of aerosolized amikacin via the PDDS clinical device at a nominal dose of 400 mg every 12 h for 7-14 days
Drug: Amikacin inhalation solution (BAY41-6551)
Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects with confirmed pneumonia, defined as the presence of a new progressive infiltrate(s) on chest radiograph and the presence of gram-negative organism by either culture or Gram stain of respiratory secretions. The subject must be intubated and mechanically ventilated and expected to remain so for at least 3 days after the start of study treatment. Subjects with a tracheostomy were also eligible.

Exclusion Criteria:

  • Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine > 2mg/dl and chronic liver disease
  • Had primary lung cancer or another malignancy metastatic to the lungs
  • Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia
  • Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
  • Had a body mass index of ≥30 kg/m2
  • Had burns >40% of total body surface area
  • Had known local or systemic hypersensitivity to amikacin or aminoglycosides
  • Had a diagnosis of end-stage renal failure or were currently on dialysis treatment
  • Had a serum albumin level <2 g/dL at Screening
  • Used amikacin by any route within 7 days before the start of study treatment
  • Had a presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and Follow-Up could be completed
  • Had known respiratory colonization with amikacin-resistant gram-negative rods
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021436

Locations
United States, Alabama
Birminghan, Alabama, United States, 35233
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Houston, Texas, United States, 77030
France
Paris, Cedex 13, France, 75651
Limoges, Cedex, France, 87046
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01021436     History of Changes
Other Study ID Numbers: 06-IN-AK004  2006-005079-17 
Study First Received: November 25, 2009
Last Updated: February 17, 2016
Health Authority: France: French Health Products Safety Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
Pneumonia
Gram-negative bacteria

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 21, 2016