Pneumonia
Conditions
Keywords
Pneumonia, Gram-negative bacteria
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
Interventions
Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour
Sponsors
Nektar Therapeutics
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Approximately 6 weeks |
Countries
France, United States
Outcome results
None listed