N/A
N=16
Community Central Line Infection Prevention Trial
Infection
Bottom Line
View on ClinicalTrials.gov: NCT02351258 ↗Enrolled (actual)
16
Serious AEs
—
Results posted
May 2020
Primary outcome: Primary: Total Number of Central Line Associated Blood Stream Infections (CLABSI) — 113; 84; 123; 109 infections
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 70% Isopropyl alcohol embedded caps (Device); Usual Care (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Central Line Associated Blood Stream Infections (CLABSI) |
113; 84; 123; 109 | — |
| SECONDARY Total Number of Mucosal Barrier Injury Central Line-associated Bloodstream Infections (MBI-CLABSI) |
14; 8; 16; 10 | — |
| SECONDARY Total Number of Ambulatory Secondary Bloodstream Infections (Secondary BSI) |
11; 0; 11; 0 | — |
| SECONDARY Total Number of Ambulatory Single Positive Blood Cultures (SPBC) |
29; 42; 36; 51 | — |
| SECONDARY Total Number of Ambulatory Positive Blood Culture |
167; 134; 186; 170 | — |
| SECONDARY Total Number of Acquired Pathogens |
69; 63; 72; 75; 3; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- pediatric outpatients with either hematologic or oncologic diagnosis who have an external central line
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT02351258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.