Recruiting
Phase 1

Cefazolin

Sponsor:

Drexel University

Code:

NCT03672149

Conditions

Renal Replacement Therapy

Pharmacokinetics

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cefazolin

Study Details

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

Study ID

NCT03672149

Start date

Jul 18, 2019

Status verified date

Oct, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 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.

other: 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.

other: 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.

Interventions

Cefazolin

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

Primary outcome measure

  • Cefazolin serum levels [ Time Frame: 72-96 hours ]

Central Contacts and Locations

Locations

St. Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Jeffrey Cies

215-427-5176jeffrey.cies@gmail.com

More Information

Sponsor

Drexel University

Last update posted

Oct 19, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Drexel University on 2020-10-19.