Recruiting

Ceftazidime-Avibactam

Sponsor:

Temple University

Code:

NCT03243864

Conditions

Renal Failure

Bacterial Infections

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ceftazidime-avibactam

Study Details

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.

Conditions

Renal Failure

Bacterial Infections

Critical Illness

Study ID

NCT03243864

Start date

Mar 13, 2017

Status verified date

Apr, 2019

Completion date

Oct 21, 2020

Anticipated

Primary completion date

Mar 21, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Ceftazidime and Avibactam

Ceftazidime-avibactam pharmacokinetic monitoring

Interventions

Ceftazidime-avibactam

Patients will be started on 2.5 gm IV every 8 hours

Primary outcome measure

  • Ceftazidime plasma concentrations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]

Central Contacts and Locations

Central contacts

Christina Rose, Pharm.D.

215-707-8057rosecm@temple.edu

Daniel Mueller, MD

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

Locations

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Christina Rose, Pharm.D.

215-707-8057rosecm@temple.edu

More Information

Sponsor

Temple University

Last update posted

Apr 10, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2019-04-10.