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drugset / Trial / NCT01401010

Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients

NCT01401010 ↗

Phase 4 Completed 12 enrolled Gary E. Stein, Pharm.D.
RandomizedSingle-groupOpen-labelTreatment

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))

Timeline

Start
2010-08
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doripenem Small molecule 500 mg Intravenous
Comparator Doripenem Small molecule 1000 mg Intravenous

Indications

neutropenia