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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

November 25, 2009
February 17, 2016
March 2007
August 2007   (final data collection date for primary outcome measure)
  • 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 ]
Male serum C(max), T(max) and AUC( 0-12hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021436 on ClinicalTrials.gov Archive Site
Number of participants with adverse events [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: Yes ]
  • Mean urine Xu(0-12 hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Mean urine Xu(12-24 hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Mean urine Xu(0-24 hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Assessment of adverse Events related to the study drug or study device [ Time Frame: Treatment period, test of cure visit, follow-up visit ] [ Designated as safety issue: Yes ]
  • Assessment of abnormal lab values [ Time Frame: Treatment period, test of cure visit, follow-up visit ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
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
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
Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumonia
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
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
Intervention: Drug: Amikacin inhalation solution (BAY41-6551)
Luyt CE, Clavel M, Guntupalli K, Johannigman J, Kennedy JI, Wood C, Corkery K, Gribben D, Chastre J. Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia. Crit Care. 2009;13(6):R200. doi: 10.1186/cc8206. Epub 2009 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01021436
06-IN-AK004, 2006-005079-17
No
Not Provided
Not Provided
Bayer
Bayer
Nektar Therapeutics
Study Director: Bayer Study Director Bayer
Bayer
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP