Recruiting
Phase 1

Vancomycin

Sponsor:

Drexel University

Code:

NCT02663596

Conditions

Pediatric Continuous Renal Replacement Therapy

Dialysis

Renal Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Vancomycin

Study Details

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.

Conditions

Pediatric Continuous Renal Replacement Therapy

Dialysis

Renal Failure

Study ID

NCT02663596

Start date

Jan, 2017

Status verified date

Oct, 2020

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vancomycin

Patients with vancomycin mixed in the CRRT solution(s)

Interventions

Vancomycin

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)

Primary outcome measure

  • Number of patients with therapeutic vancomycin serum levels [ Time Frame: Until the end of the study, up to 33 months ]

Central Contacts and Locations

Central contacts

Jeffrey J Cies, PharmD, MPH

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

Locations

St. Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Jeffrey J Cies, PharmD, MPH, BCPS-AQ ID, BCPPS

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

More Information

Sponsor

Drexel University

Last update posted

Oct 19, 2020

Last verified

Oct, 2020

Keywords

  • Pediatric
  • Continuous Renal Replacement Therapy
  • Dialysis
  • Therapeutic drug monitoring
  • Pharmacokinetics
  • Pharmacodynamics

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.