check_circleStudy Completed

Pneumonia

Bayer Identifier:

06-IN-AK004

ClinicalTrials.gov Identifier:

NCT01021436

EudraCT Number:

2006-005079-17

EU CT Number:

Not Available
Safety, tolerability and pharmacokinetics of aerosolized amikacin in intubated and mechanically-ventilated patients with nosocomial pneumonia

Trial 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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
30
Trial Dates
March 2007 - August 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Amikacin Inhalation Solution (BAY41-6551)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hôpital de la Pitié - SalpétrièParis, 75651, France
Completed
CHU DupuytrenLimoges, 87046, France
Completed
Baylor College of MedicineHouston, 77030, US
Completed
University of Cincinnati Medical CenterCincinnati, 45267, US
Completed
VA Medical CenterBirminghan, 35233, US
Completed
University of Tennessee Health Science CenterMemphis, 38163, US

Primary Outcome

  • Cmax
    Maximum serum amikacin concentration observed from time 0 to 12 h
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Tmax
    Time that Cmax occurred
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • AUC0-12h
    Area under the serum amikacin concentration vs time curve from time 0 to 12 h
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Xu0-12h
    Amount of amikacin excreted in urine from 0 to 12 h after dosing
    date_rangeTime Frame:
    On Day 3 at the start of dose and up to 12 h after both first and second dose
    enhanced_encryption
    Safety Issue:
    No
  • Xu12-24h
    Amount of amikacin excreted in urine from 12 to 24 h after dosing
    date_rangeTime Frame:
    On Day 3 at the start of dose and up to 12 h after both first and second dose
    enhanced_encryption
    Safety Issue:
    No
  • Xu0-24h
    Amount of amikacin excreted in urine from 0 to 24 h after dosing
    date_rangeTime Frame:
    On Day 3 at the start of dose and up to 12 h after both first and second dose
    enhanced_encryption
    Safety Issue:
    No
  • Tracheal aspirate
    date_rangeTime Frame:
    Day 3
    enhanced_encryption
    Safety Issue:
    No
  • Epithelial lining fluid (ELF) concentration
    date_rangeTime Frame:
    Approximately 15-30 min after completion of the morning dose of study medication on Day 3
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for drug information provided by the FDAClick here to find information about studies related to Bayer Healthcare products conducted in Europe.Click here to find results for studies related to Bayer Healthcare products.