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
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
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 |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer | Nektar Therapeutics |
United States, France,
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
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 |
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