Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF

NCT04358991 | Completed Results FDA Drug

• 1 other identifier: I# 0058410
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients

  PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration

  8 hours

Study Arms (1)

invasive bacterial infections

patients who are receiving Ceftazidime-avibactam are asked to provide blood samples around a dosing of the medication for analysis of samples

Drug: Ceftazidime-avibactam

Interventions

Ceftazidime-avibactam DRUG

collection of blood samples around clinical dosing immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, 8, and 12 hours and EMR review.

invasive bacterial infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with confirmed or presumed invasive bacterial infections

You may qualify if:

• Adult patients receiving ceftazidime-avibactam as standard care

You may not qualify if:

• Less than 18 years-old

Sponsors & Collaborators

• University of Pittsburgh: lead
• Allergan: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be collected immediately before, and then at the following times thereafter intravenous administration of ceftazidime-avibactam: 1, 2, 4, 6, and 8 hours

MeSH Terms

Conditions

Bacterial Infections

Interventions

avibactam, ceftazidime drug combination

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. Ryan Shields, Associate Professor of Medicine
• Organization: University of Pittsburgh

shieldsrk@upmc.edu

412-864-3745

Study Officials

• Ryan Shields, Pharm D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 29, 2020
• Results First Posted: May 15, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Within 1 year of study completion
• Access Criteria: will be on clinicaltrials.gov

Locations

US (1)