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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021436
• Other study ID #: 06-IN-AK004
• Secondary ID: 2006-005079-17
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2009
• Last updated: February 17, 2016
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Health Products Safety AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Nektar Therapeutics

Countries where clinical trial is conducted

United States,  France, 

References & 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. Cr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Tracheal aspirate		Day 3	No
Primary	Epithelial lining fluid (ELF) concentration		Approximately 15-30 min after completion of the morning dose of study medication on Day 3	No
Secondary	Number of participants with adverse events		Approximately 6 weeks	Yes

External Links

•   Click here and search for drug information provided by the FDA
•   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 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.