Clinical trial NCT01021436: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Keywords: Pneumonia
Gram-negative bacteria
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Nektar Therapeutics
First posted: 2009-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Cmax
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: AUC0-12h
timeFrame: 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
measure: Xu0-12h
timeFrame: On Day 3 at the start of dose and up to 12 h after both first and second dose
measure: Xu12-24h
timeFrame: On Day 3 at the start of dose and up to 12 h after both first and second dose
measure: Xu0-24h
timeFrame: On Day 3 at the start of dose and up to 12 h after both first and second dose
measure: Tracheal aspirate
timeFrame: Day 3
measure: Epithelial lining fluid (ELF) concentration
timeFrame: Approximately 15-30 min after completion of the morning dose of study medication on Day 3
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Approximately 6 weeks
Other outcomes:
Locations:
city: Birminghan
country: United States
state: Alabama
city: Cincinnati
country: United States
state: Ohio
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Paris
country: France
state: Cedex 13
city: Limoges
country: France
state: Cedex
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.