Overview

Safety and TDM of Continuous Infusion Vancomycin Through Continuous Renal Replacement Therapy Solution

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this investigation is to evaluate the safety of delivering continuous infusion (CI) vancomycin in pediatric CRRT by utilizing CI via by mixing the vancomycin into the CRRT solution(s). The secondary objectives are to describe the ability to achieve therapeutic vancomycin concentrations by utilizing this new delivery technique. Primary Objectives: To determine whether delivering continuous infusion vancomycin mixed into the CRRT solution can maintain therapeutic levels of drug in patients being treated for proven or suspected Gram-positive bacterial infections.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Drexel University

Collaborator:

The Center for Pediatric Pharmacotherapy, LLC

Treatments:

Pharmaceutical Solutions
Vancomycin

Criteria

Inclusion Criteria

Patients eligible to participate in the study must meet all of the following criteria prior
to any study-related procedure:

1. The 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

2. Documented or suspected Gram-positive bacterial infection necessitating the use of
vancomycin while receiving CRRT.

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 vancomcyin
(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. Planned or prior participation in any other interventional drug study within 30 days

5. Females that are pregnant or breastfeeding