NCT02663596

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4.9 years

First QC Date

January 12, 2016

Last Update Submit

October 14, 2020

Conditions

Pediatric Continuous Renal Replacement TherapyDialysisRenal Failure

Keywords

PediatricContinuous Renal Replacement TherapyDialysisTherapeutic drug monitoringPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Number of patients with therapeutic vancomycin serum levels

    The CRRT circuit (tubing, filter) will be inspected and evaluated for flow rates and clotting hourly

    Until the end of the study, up to 33 months

Study Arms (1)

Vancomycin

EXPERIMENTAL

Patients with vancomycin mixed in the CRRT solution(s)

Drug: Vancomycin

Interventions

VancomycinDRUG

Patient requiring CRRT and vancomycin that provide consent will be given vancomycin as a continuous infusion by mixing the vancomycin into the CRRT solution(s)

Also known as: Continuous renal replacement therapy solutions
Vancomycin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible to participate in the study must meet all of the following criteria prior to any study-related procedure:
  • \. The 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
  • \. Documented or suspected Gram-positive bacterial infection necessitating the use of vancomycin while receiving CRRT.

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 vancomcyin (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
  • Planned or prior participation in any other interventional drug study within 30 days
  • Females that are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jeffrey J Cies, PharmD, MPH

    Drexel University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey J Cies, PharmD, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacy Clinical Coordinator, Critical Care and Infectious Diseases Clinical Pharmacist

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 26, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

US(1)