Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
- Registration Number
- NCT01021436
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amikacin inhalation solution Amikacin inhalation solution (BAY41-6551) 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
- Primary Outcome Measures
Name Time Method Cmax 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 Maximum serum amikacin concentration observed from time 0 to 12 h
Tmax 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 Time that Cmax occurred
AUC0-12h 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 Area under the serum amikacin concentration vs time curve from time 0 to 12 h
Xu0-12h On Day 3 at the start of dose and up to 12 h after both first and second dose Amount of amikacin excreted in urine from 0 to 12 h after dosing
Xu12-24h On Day 3 at the start of dose and up to 12 h after both first and second dose Amount of amikacin excreted in urine from 12 to 24 h after dosing
Xu0-24h On Day 3 at the start of dose and up to 12 h after both first and second dose Amount of amikacin excreted in urine from 0 to 24 h after dosing
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 Outcome Measures
Name Time Method Number of participants with adverse events Approximately 6 weeks