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
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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 |
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Infection | Device: 70% Isopropyl alcohol embedded caps Other: Usual Care | Not Applicable |

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 |

Arm | Intervention/treatment |
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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.
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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;
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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.
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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;
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- 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
- 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)
- Total Number of Ambulatory Secondary Bloodstream Infections (Secondary BSI) [ Time Frame: 2 years ]To obtain rate of ambulatory secondary bloodstream infections
- Total Number of Ambulatory Single Positive Blood Cultures (SPBC) [ Time Frame: 2 years ]To obtain rate of ambulatory single positive blood culture (SPBC)
- Total Number of Ambulatory Positive Blood Culture [ Time Frame: 2 years ]To obtain rate of ambulatory positive blood culture rate
- 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 |
Inclusion Criteria:
- pediatric outpatients with either hematologic or oncologic diagnosis who have an external central line
Exclusion Criteria:
- none

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
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 |
Principal Investigator: | Marlene R. Miller, MD, MSc | University Hospitals | |
Principal Investigator: | Aaron Milstone, MD, MHS | Johns Hopkins University |
Documents provided by Johns Hopkins University:
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 |
Pediatrics Medical Oncology Catheters Infection |
Infections Communicable Diseases Disease Attributes Pathologic Processes |