Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis

NCT ID: NCT03243864

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-13

Study Completion Date

2020-10-21

Brief Summary

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The study's primary objective is to determine plasma and dialysis fluid concentrations in patients prescribed ceftazidime-avibactam as the standard treatment for their infection and requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the prescribed dose meets pharmacodynamic targets.

Detailed Description

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Conditions

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Renal Failure Bacterial Infections Critical Illness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ceftazidime and Avibactam

Ceftazidime-avibactam pharmacokinetic monitoring

Ceftazidime-avibactam

Intervention Type DRUG

Patients will be started on 2.5 gm IV every 8 hours

Interventions

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Ceftazidime-avibactam

Patients will be started on 2.5 gm IV every 8 hours

Intervention Type DRUG

Other Intervention Names

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Avycaz

Eligibility Criteria

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Inclusion Criteria

* Adults \> 18 years of age
* Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure
* documented or suspected infection requiring a prescription for ceftazidime-avibactam

Exclusion Criteria

* Patients on CRRT \< 24 hours
* Patients on ceftazidime-avibactam \< 24 hours
* Patients unable to remain on CRRT for 32 hours continuously without clotting
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Rose, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina Rose, Pharm.D.

Role: CONTACT

215-707-8057

Daniel Mueller, MD

Role: CONTACT

215-707-1982

Facility Contacts

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Christina Rose, Pharm.D.

Role: primary

215-707-8057

Other Identifiers

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866

Identifier Type: -

Identifier Source: org_study_id

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