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

• ClinicalTrials.gov Identifier: NCT03672149
• Recruitment Status: Recruiting
• First Posted: September 14, 2018
• Last Update Posted: October 19, 2020
• Sponsor: Drexel University
• Collaborator: The Center for Pediatric Pharmacotherapy
• Information provided by (Responsible Party): Jeffrey J. Cies,PharmD,MPH,BCPS-AQ ID,BCPPS,FCCP,FCCM,FPPAG, Drexel University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Renal Replacement Therapy; Pharmacokinetics	Drug: Cefazolin	Phase 1

Detailed Description:

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 in addition to utilizing a dosing algorithm to adjust the cefazolin concentration in the CRRT solution.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment

Intervention Model Description

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.

• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Prospective, Open-Label Study of the Safety and Therapeutic Drug Monitoring of Continuous Infusion Cefazolin Through the Addition of the Cefazolin Into the Continuous Renal Replacement Therapy Solution.
• Actual Study Start Date: July 18, 2019
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Infection needing cefazolin; 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; Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion; Other Name: CRRT solutions
Infection not needing cefazolin; 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; Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion; Other Name: CRRT solutions
No infection; 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; Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion; Other Name: CRRT solutions

Outcome Measures

Primary Outcome Measures :

1. Cefazolin serum levels [ Time Frame: 72-96 hours ]
   Therapeutic serum cefazolin levels. Serum samples will be obtained at specified intervals during the course of CRRT for cefazolin concentration determination.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Patients eligible to participate in the study must have a need for continuous renal replacement therapy (CRRT) of any modality:

1. CVVH-continuous veno-venous hemofiltration
2. CVVHD-continuous veno-venous hemodialysis
3. CVVHDF-continuous veno-venous hemodiafiltration

Exclusion Criteria:

Patients will be considered ineligible if they meet any of the following criteria:

1. 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)
2. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
4. Females that are pregnant or breastfeeding

Contacts and Locations

Locations

United States, Pennsylvania

St. Christopher's Hospital for Children; Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contact: Jeffrey Cies 215-427-5176 jeffrey.cies@gmail.com

Sponsors and Collaborators

Drexel University

The Center for Pediatric Pharmacotherapy

More Information

• Responsible Party: Jeffrey J. Cies,PharmD,MPH,BCPS-AQ ID,BCPPS,FCCP,FCCM,FPPAG, Principal Investigator, Drexel University
• ClinicalTrials.gov Identifier: NCT03672149
• Other Study ID Numbers: 1805006375
• First Posted: September 14, 2018
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cefazolin; Anti-Bacterial Agents; Anti-Infective Agents