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Community Central Line Infection Prevention Trial (CCLIP)

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ClinicalTrials.gov Identifier: NCT02351258
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Infection Device: 70% Isopropyl alcohol embedded caps Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community Central Line Infection Prevention Trial
Actual Study Start Date : November 2015
Actual Primary Completion Date : September 9, 2019
Actual Study Completion Date : September 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Usual Care only, then Usual Care + 70% Isopropyl Alcohol
Usual care for central line while patients are at home and then switch to usual care plus 70% isopropyl alcohol after washout.
Device: 70% Isopropyl alcohol embedded caps
Protective cap on central lines
Other Name: Curos Cap by Ivera Medical Corporation

Other: Usual Care

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

Experimental: Usual Care + 70% Isopropyl Alcohol, then Usual Care only
Use 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.
Device: 70% Isopropyl alcohol embedded caps
Protective cap on central lines
Other Name: Curos Cap by Ivera Medical Corporation

Other: Usual Care

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




Primary Outcome Measures :
  1. Total Number of Central Line Associated Blood Stream Infections (CLABSI) [ Time Frame: 2 years ]
    To obtain rate of ambulatory central line associated blood stream infections in ambulatory patients


Secondary Outcome Measures :
  1. Total Number of Mucosal Barrier Injury Central Line-associated Bloodstream Infections (MBI-CLABSI) [ Time Frame: 2 years ]
    To obtain rate of ambulatory Mucosal Barrier Injury central line-associated bloodstream infections (MBI-CLABSI)

  2. Total Number of Ambulatory Secondary Bloodstream Infections (Secondary BSI) [ Time Frame: 2 years ]
    To obtain rate of ambulatory secondary bloodstream infections

  3. Total Number of Ambulatory Single Positive Blood Cultures (SPBC) [ Time Frame: 2 years ]
    To obtain rate of ambulatory single positive blood culture (SPBC)

  4. Total Number of Ambulatory Positive Blood Culture [ Time Frame: 2 years ]
    To obtain rate of ambulatory positive blood culture rate

  5. Total Number of Acquired Pathogens [ Time Frame: 2 years ]
    Organism distribution of Gram positive bacteria, Gram negative bacteria, fungi, or other.



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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351258


Locations
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United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Colorado
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
United States, Delaware
Nemours Alfred Dupont Hospital for Children
Wilmington, Delaware, United States, 19603
United States, Florida
University of Florida Children's Hospital
Gainesville, Florida, United States, 32608
United States, Kentucky
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Children's Hospital of Montefiore
Bronx, New York, United States, 10467
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Johns Hopkins University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Marlene R. Miller, MD, MSc University Hospitals
Principal Investigator: Aaron Milstone, MD, MHS Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02351258    
Other Study ID Numbers: IRB00046284
R01HS022870 ( U.S. AHRQ Grant/Contract )
First Posted: January 30, 2015    Key Record Dates
Results First Posted: May 20, 2020
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participating individuals are at the hospital level via hospital ambulatory central line infection rates
Keywords provided by Johns Hopkins University:
Pediatrics
Medical Oncology
Catheters
Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases