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

NCT01021436 | Completed Phase 2

• 2 other identifiers: 06-IN-AK0042006-005079-17
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Pneumonia

Keywords

Pneumonia; Gram-negative bacteria

Outcome Measures

Primary Outcomes (8)

• Cmax

  Maximum serum amikacin concentration observed from time 0 to 12 h

  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

• Tmax

  Time that Cmax occurred

  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

• AUC0-12h

  Area under the serum amikacin concentration vs time curve from time 0 to 12 h

  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

• Xu0-12h

  Amount of amikacin excreted in urine from 0 to 12 h after dosing

  On Day 3 at the start of dose and up to 12 h after both first and second dose

• Xu12-24h

  Amount of amikacin excreted in urine from 12 to 24 h after dosing

  On Day 3 at the start of dose and up to 12 h after both first and second dose

• Xu0-24h

  Amount of amikacin excreted in urine from 0 to 24 h after dosing

  On Day 3 at the start of dose and up to 12 h after both first and second dose

• Tracheal aspirate

  Day 3

• Epithelial lining fluid (ELF) concentration

  Approximately 15-30 min after completion of the morning dose of study medication on Day 3

Secondary Outcomes (1)

• Number of participants with adverse events

  Approximately 6 weeks

Study Arms (1)

Amikacin inhalation solution

EXPERIMENTAL

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)

Interventions

Amikacin inhalation solution (BAY41-6551) DRUG

Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour

Amikacin inhalation solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Nektar Therapeutics: collaborator

Study Sites (6)

Unknown Facility

Birminghan, Alabama, 35233, United States

Location

Unknown Facility

Cincinnati, Ohio, 45267, United States

Location

Unknown Facility

Memphis, Tennessee, 38163, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Paris, Cedex 13, 75651, France

Location

Unknown Facility

Limoges, Cedex, 87046, France

Location

Related Publications (1)

• 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.

  PMID: 20003269 RESULT

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: March 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

US (4); FR (2)