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

Primary Purpose

Pneumonia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Amikacin inhalation solution (BAY41-6551)

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, Gram-negative bacteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amikacin inhalation solution

Arm Description

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

Outcomes

Primary Outcome Measures

Cmax

Maximum serum amikacin concentration observed from time 0 to 12 h

Tmax

Time that Cmax occurred

AUC0-12h

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

Xu0-12h

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

Xu12-24h

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

Xu0-24h

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

Tracheal aspirate

Epithelial lining fluid (ELF) concentration

Secondary Outcome Measures

Number of participants with adverse events

Full Information

NCT ID

NCT01021436

First Posted

November 25, 2009

Last Updated

February 17, 2016

Sponsor

Bayer

Collaborators

Nektar Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01021436

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

Nektar Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

Pneumonia, Gram-negative bacteria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amikacin inhalation solution

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Amikacin inhalation solution (BAY41-6551)

Intervention Description

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

Primary Outcome Measure Information:

Title

Cmax

Description

Maximum serum amikacin concentration observed from time 0 to 12 h

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

Title

Tmax

Description

Time that Cmax occurred

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

Title

AUC0-12h

Description

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

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

Title

Xu0-12h

Description

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

Time Frame

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

Title

Xu12-24h

Description

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

Time Frame

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

Title

Xu0-24h

Description

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

Time Frame

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

Title

Tracheal aspirate

Time Frame

Day 3

Title

Epithelial lining fluid (ELF) concentration

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

Approximately 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Birminghan

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

Paris

State/Province

Cedex 13

ZIP/Postal Code

75651

Country

France

City

Limoges

State/Province

Cedex

ZIP/Postal Code

87046

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

20003269

Citation

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.

Results Reference

result

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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

Learn more about this trial

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

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