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Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients

NCT01401010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-10-14

Study results available
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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))

Conditions

Interventions

DRUG

Doripenem

500 mg every 8 hours

DRUG

doripenem

1000 mg every 8 hours

Sponsors & Collaborators

  • Gary E. Stein, Pharm.D.

    lead OTHER

Principal Investigators

  • Gary Stein, PharmD · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401010 on ClinicalTrials.gov