Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy

NCT03672149 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 1805006375
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is intended to collect safety information for the technique of mixing cefazolin in the CRRT solution on the CRRT circuit, the patient, in addition to collecting information regarding the ability to obtain therapeutic cefazolin serum concentrations

Conditions

Renal Replacement Therapy; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Cefazolin serum levels

  Therapeutic serum cefazolin levels. Serum samples will be obtained at specified intervals during the course of CRRT for cefazolin concentration determination.

  72-96 hours

Study Arms (3)

Infection needing cefazolin

OTHER

a) If a patient requires antimicrobial therapy for a proven or suspected infection at the time of CRRT initiation or at any time receiving CRRT, they are eligible for inclusion. If cefazolin is part of the empiric or definitive treatment regimen, it will be mixed in the CRRT solution(s) and administered via a continuous infusion to obtain pharmacokinetic and safety data of administering cefazolin via the CRRT solution and infection treatment related data. For this indication, pharmacokinetic and safety data will be obtained for the duration the patient receives cefazolin via the CRRT solution(s) for the proven or suspected infection as dictated by the primary team caring for the patient.

Drug: Cefazolin

Infection not needing cefazolin

OTHER

b) If a patient is deemed a candidate for CRRT and requires therapy with any anti-microbial for a proven or suspected infection not requiring cefazolin as part of the anti-microbial drug regimen, administration of cefazolin via the CRRT solution(s) will occur to solely obtain pharmacokinetic and safety data. For this indication, pharmacokinetic and safety data will be obtained for a 72-96-hour duration.

Drug: Cefazolin

No infection

OTHER

c) If a patient is deemed a candidate for CRRT and does not require any anti-microbial therapy, administration of cefazolin via the CRRT solution(s) will occur to solely obtain pharmacokinetic and safety data. For this indication, pharmacokinetic and safety data will be obtained for a 72-96-hour duration.

Drug: Cefazolin

Interventions

Cefazolin DRUG

Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion

Also known as: CRRT solutions

Infection needing cefazolin; Infection not needing cefazolin; No infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible to participate in the study must have a need for continuous renal replacement therapy (CRRT) of any modality:
• CVVH-continuous veno-venous hemofiltration
• CVVHD-continuous veno-venous hemodialysis
• CVVHDF-continuous veno-venous hemodiafiltration

You may not qualify if:

• Patients will be considered ineligible if they meet any of the following criteria:
• History of any moderate or severe hypersensitivity or allergic reaction to cefazolin (a history of mild rash followed by uneventful re-exposure and/or red man syndrome is not a contraindication)
• Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
• Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
• Females that are pregnant or breastfeeding

Sponsors & Collaborators

• Drexel University: lead
• The Center for Pediatric Pharmacotherapy: collaborator

Study Sites (1)

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. If cefazolin is part of the empiric or definitive treatment regimen, it will be mixed in the CRRT solution(s) and administered via a continuous infusion to obtain treatment, pharmacokinetic, and safety data . 2. If cefazolin is not part of the empiric or definitive treatment regimen, it will be mixed in the CRRT solution(s) and administered via a continuous infusion to obtain pharmacokinetic, and safety data . 3. If a patient does not require any anti-microbial therapy, cefazolin will be given via the CRRT solution(s) to solely obtain pharmacokinetic and safety data.

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 14, 2018
• Study Start: July 18, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)