NCT03243864

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

August 1, 2017

Last Update Submit

April 8, 2019

Conditions

Renal FailureBacterial InfectionsCritical Illness

Outcome Measures

Primary Outcomes (4)

  • Ceftazidime plasma concentrations

    mg/L

    At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

  • Avibactam plasma concentrations

    mg/L

    At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

  • Ceftazidime effluent concentrations

    mg/L

    At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

  • Avibactam effluent concentrations

    mg/L

    At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

Secondary Outcomes (7)

  • Maximum plasma concentration (Cmax)

    At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

  • Number of participants with adverse effects as a measure of safety

    Days 1-30

  • Minimum plasma concentration (Cmin)

    At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

  • Half-life (t1/2)

    8-hours

  • Clearance (Cl)

    8-hours

  • +2 more secondary outcomes

Study Arms (1)

Ceftazidime and Avibactam

Ceftazidime-avibactam pharmacokinetic monitoring

Drug: Ceftazidime-avibactam

Interventions

Ceftazidime-avibactamDRUG

Patients will be started on 2.5 gm IV every 8 hours

Also known as: Avycaz
Ceftazidime and Avibactam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients

You may qualify if:

  • 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

You may not qualify if:

  • Patients on CRRT \< 24 hours
  • Patients on ceftazidime-avibactam \< 24 hours
  • Patients unable to remain on CRRT for 32 hours continuously without clotting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Biospecimen

Retention: NONE RETAINED

Whole blood, plasma, effluent fluid from dialysis machine

MeSH Terms

Conditions

Renal InsufficiencyBacterial InfectionsCritical Illness

Interventions

avibactam, ceftazidime drug combination

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christina Rose, Pharm.D.

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Rose, Pharm.D.

CONTACT

215-707-8057rosecm@temple.edu

Daniel Mueller, MD

CONTACT

215-707-1982Daniel.Mueller2@tuhs.temple.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 9, 2017

Study Start

March 13, 2017

Primary Completion

March 21, 2020

Study Completion

October 21, 2020

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)