NCT01401010

Brief 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))

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 5, 2012

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

July 14, 2011

Results QC Date

March 6, 2012

Last Update Submit

October 12, 2015

Conditions

Febrile Neutropenia

Keywords

neutropeniadoripenem

Outcome Measures

Primary Outcomes (5)

  • Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients

    To determine the serum pharmacokinetic volume of distribution of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.

    1, 4, 6, 8 hours after at least two doses of drug

  • Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients

    To determine the serum pharmacokinetic elimination rate constant of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.

    1, 4, 6, 8 hours after at least two doses of drug

  • Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients

    To determine the serum pharmacokinetic half life of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.

    1, 4, 6, 8 hours after at least two doses of drug

  • Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients

    To determine the serum pharmacokinetic clearance of drug of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.

    1, 4, 6, 8 hours after at least two doses of drug

  • Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients

    To determine the serum pharmacokinetic area under serum curve of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.

    1, 4, 6, 8 hours after at least two doses of drug

Secondary Outcomes (1)

  • Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC))

    1, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters

Study Arms (2)

Doripenem 500 mg

ACTIVE COMPARATOR

pharmacokinetics/pharmacodynamics

Drug: Doripenem

Doripenem 1000 mg

ACTIVE COMPARATOR

pharmacokinetics/pharmacodynamics

Drug: doripenem

Interventions

doripenemDRUG

500 mg every 8 hours

Also known as: Doribac
Doripenem 500 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sparrow Hospital

Lansing, Michigan, 48910, United States

Location

MeSH Terms

Conditions

Febrile NeutropeniaNeutropenia

Interventions

Doripenem

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Gary E Stein
Organization
Michigan State University
Gary.Stein@hc.msu.edu
517-353-5126

Study Officials

  • Gary Stein, PharmD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine and Pharmacology

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 25, 2011

Study Start

August 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 14, 2015

Results First Posted

June 5, 2012

Record last verified: 2015-10

Locations

US(1)