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NCT02351258 · ClinicalTrials.gov registry record · NA

Community Central Line Infection Prevention Trial

A NA study of Infection, sponsored by Johns Hopkins University.

Completed
Registry status
NA
Development phase
16
Enrollment target
16
Study locations

NCT02351258 is a NA study of Infection that has completed, run by Johns Hopkins University. The registered enrollment target is 16 participants, below the 726-participant average among 41 other Infection trials with a reported enrollment target (98% lower). The trial reports 16 study locations across 14 states.

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The verdict

NCT02351258, a NA study of Infection, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
NA
Development phase
16 participants
Enrollment target
16
Study locations

Study 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

Conditions Studied

Infection

Interventions

  • OTHER Usual Care
  • DEVICE 70% Isopropyl alcohol embedded caps

Study Locations (16)

Maryland

  • Johns Hopkins Children's Center - Baltimore
  • Johns Hopkins University - Baltimore

Ohio

  • Akron Children's Hospital - Akron
  • Nationwide Children's Hospital - Columbus

Alabama

  • Children's Hospital of Alabama - Birmingham

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Children's Hospital of Colorado - Aurora

Delaware

  • Nemours Alfred Dupont Hospital for Children - Wilmington

Florida

  • University of Florida Children's Hospital - Gainesville

Kentucky

  • Norton Children's Hospital - Louisville

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2015-11
Est. Completion 2019-09-09
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

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What the Registry Record Tells You About NCT02351258

The ClinicalTrials.gov registry entry for NCT02351258 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 726-participant average among 41 other Infection trials with a reported enrollment target (98% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infection appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.

NCT02351258 reports 16 study locations spanning 14 distinct geographic areas - top geographies include Maryland, Ohio, Alabama.

Frequently Asked Questions

What is clinical trial NCT02351258 about?

NCT02351258 is a clinical study titled "Community Central Line Infection Prevention Trial". 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...

What is the current status of trial NCT02351258?

This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2015-11. Estimated completion is 2019-09-09.

What conditions does trial NCT02351258 study?

This clinical trial studies the following conditions: Infection.

What interventions are being tested in trial NCT02351258?

The interventions under investigation include: Usual Care (OTHER), 70% Isopropyl alcohol embedded caps (DEVICE).

Who is sponsoring clinical trial NCT02351258?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02351258 being conducted?

This trial has 16 study locations across Alabama, Arkansas, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.