Community Central Line Infection Prevention Trial
CCLIP
2 other identifiers
interventional
16
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2019
CompletedResults Posted
Study results publicly available
May 20, 2020
CompletedMay 20, 2020
May 1, 2020
3.9 years
January 27, 2015
May 5, 2020
May 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Number of Central Line Associated Blood Stream Infections (CLABSI)
To obtain rate of ambulatory central line associated blood stream infections in ambulatory patients
2 years
Secondary Outcomes (5)
Total Number of Mucosal Barrier Injury Central Line-associated Bloodstream Infections (MBI-CLABSI)
2 years
Total Number of Ambulatory Secondary Bloodstream Infections (Secondary BSI)
2 years
Total Number of Ambulatory Single Positive Blood Cultures (SPBC)
2 years
Total Number of Ambulatory Positive Blood Culture
2 years
Total Number of Acquired Pathogens
2 years
Study Arms (2)
Usual Care only, then Usual Care + 70% Isopropyl Alcohol
EXPERIMENTALUsual care for central line while patients are at home and then switch to usual care plus 70% isopropyl alcohol after washout.
Usual Care + 70% Isopropyl Alcohol, then Usual Care only
EXPERIMENTALUse of 70% isopropyl alcohol embedded caps on central lines in addition to usual care of central line in the home setting and then switch to usual care only after washout.
Interventions
Protective cap on central lines
This involves the Best Practice Central Line Maintenance Care Bundle which includes; 1. Daily assessment whether central line is needed 2. Central line Site Care 3. Central line Hub/Cap/Tubing Care
Eligibility Criteria
You may qualify if:
- pediatric outpatients with either hematologic or oncologic diagnosis who have an external central line
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Nemours Alfred Dupont Hospital for Children
Wilmington, Delaware, 19603, United States
University of Florida Children's Hospital
Gainesville, Florida, 32608, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
St Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital of Montefiore
The Bronx, New York, 10467, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Doernbecher Children's Hospital
Portland, Oregon, 97239, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Milstone AM, Rosenberg C, Yenokyan G, Koontz DW, Miller MR; CCLIP Authorship Group. Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs): A randomized clinical trial. Infect Control Hosp Epidemiol. 2021 Apr;42(4):431-439. doi: 10.1017/ice.2020.467. Epub 2020 Oct 12.
PMID: 33040755DERIVED
MeSH Terms
Conditions
Results Point of Contact
- Title
- Dr. Aaron Milstone
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Marlene R. Miller, MD, MSc
University Hospitals
- PRINCIPAL INVESTIGATOR
Aaron Milstone, MD, MHS
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2015
First Posted
January 30, 2015
Study Start
November 1, 2015
Primary Completion
September 9, 2019
Study Completion
September 9, 2019
Last Updated
May 20, 2020
Results First Posted
May 20, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
Participating individuals are at the hospital level via hospital ambulatory central line infection rates