Status:
WITHDRAWN
Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy
Lead Sponsor:
Midwestern University
Collaborating Sponsors:
Northwestern University
BioCryst Pharmaceuticals
Conditions:
Influenza
Renal Failure
Eligibility:
All Genders
18+ years
Brief Summary
Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVV...
Detailed Description
This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patient is hospitalized and undergoing continuous renal replacement therapy (CRRT) as a result of the clinical management of the patient (i.e. CRRT is not initiated for the purpose of this study).
- Patient is receiving peramivir for a positive rapid antigen test for influenza or on the basis of clinical suspicion with a high local epidemiological prevalence of H1N1 disease.
- Patient has a CRRT blood flow rate greater than or equal to 100 mL/min with an ultrafiltrate +/- dialysis flow rate greater than or equal to 3000mL/hr,
- The patient is anticipated to require CRRT and peramivir treatment for a full 24 hours (i.e. life expectancy is not less than 24 hours).
- Exclusion Criteria
- The patient has received greater than 5 doses of peramivir.
- The subject has a pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
- The patient is receiving CRRT utilizing a pre-membrane dilution method.
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01146353
Start Date
February 1 2010
End Date
February 1 2011
Last Update
March 20 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Midwestern University/Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611