Community Central Line Infection Prevention Trial

Completed · Not applicable

Conditions studied: Infection

In brief

The overall goal of this Community Central Line Infection Prevention (CCLIP) trial, supported by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to determine whether use of a promising new intervention, namely 70% isopropyl alcohol embedded protective caps on central lines, in the home setting is associated with a reduction in ambulatory central line-associated bloodstream infections (CLABSI) in a high-risk population of pediatric hematology/oncology patients. Despite successes in CLABSI reduction efforts for inpatients, it remains unknown what generalizable best practices should be with chronic central lines in the home setting and how effective involving patients and caregivers across multiple institutions in CLABSI reduction efforts will be. This research will involve a cluster-randomized, cross-over design, clinical trial. This proposal will focus on the caregivers integral to ambulatory pediatric central line care: patients and families. The specific aims of the proposed research program are: Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology patients. Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric hematology/oncology patients. Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematology/oncology patients. Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the positive blood culture rate at home for pediatric hematology/oncology patients. Specific Aim #3: Evaluate whether the use of 70% isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of pediatric hematology/oncology patients. Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will reduce Gram-positive CLABSI, secondary blood steam infections, and single positive blood cultures at home for pediatric hematology/oncology patients.

Key facts

Study ID

NCT02351258

Run by

Johns Hopkins University

People needed

16

Starts

2015-11-01

Expected to finish

2019-09-09

Last updated by the study team

2020-05-20

Who can join

Age: 0 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• pediatric outpatients with either hematologic or oncologic diagnosis who have an external central line

You may not qualify if…

• none

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Nemours Alfred Dupont Hospital for Children — Wilmington, Delaware, United States
• University of Florida Children's Hospital — Gainesville, Florida, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins Children's Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• St Louis Children's Hospital — St Louis, Missouri, United States
• Children's Hospital of Montefiore — The Bronx, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Doernbecher Children's Hospital — Portland, Oregon, United States
• Medical University of South Carolina Children's Hospital — Charleston, South Carolina, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.