Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic patients.

Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT)> minimum inhibitory concentration (MIC))

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary E. Stein, Pharm.D.
• Treatments: Doripenem

Criteria

Inclusion Criteria:

• adult neutropenic (< 500 cells) patients who are febrile

Exclusion Criteria:

• Patients with Creatinine Clearance < 30 ml/min or allergy to carbapenems will be excluded.