Trial Outcomes & Findings for Community Central Line Infection Prevention Trial (NCT NCT02351258)

NCT ID: NCT02351258

Last Updated: 2020-05-20

Results Overview

To obtain rate of ambulatory central line associated blood stream infections in ambulatory patients

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

2 years

Results posted on

2020-05-20

Participant Flow

Data was collected at the clinic level, there was no data collected at the participant level and therefore there are no participant numbers available for any results modules.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	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.	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.
Intervention 1 (12 Months) STARTED	0 7	0 9
Intervention 1 (12 Months) COMPLETED	0 7	0 9
Intervention 1 (12 Months) NOT COMPLETED	0 0	0 0
Washout (2-3 Months) STARTED	0 7	0 9
Washout (2-3 Months) COMPLETED	0 7	0 9
Washout (2-3 Months) NOT COMPLETED	0 0	0 0
Intervention 2 (12 Months) STARTED	0 7	0 9
Intervention 2 (12 Months) COMPLETED	0 7	0 9
Intervention 2 (12 Months) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community Central Line Infection Prevention Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Clinics n=16 Clinics All 16 clinics included in this cluster-randomized trial.
Age, Customized < 2 years	15 percentage of participants n=6 Clinics
Age, Customized 2 - 5 years	19 percentage of participants n=6 Clinics
Age, Customized 6 - 11 years	26 percentage of participants n=6 Clinics
Age, Customized ≥ 12 years	41 percentage of participants n=6 Clinics
Sex/Gender, Customized Female	46 percentage of participants n=6 Clinics
Sex/Gender, Customized Male	54 percentage of participants n=6 Clinics
Race (NIH/OMB) American Indian or Alaska Native	NA Clinics n=6 Clinics
Race (NIH/OMB) Asian	NA Clinics n=6 Clinics
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Clinics n=6 Clinics
Race (NIH/OMB) Black or African American	NA Clinics n=6 Clinics
Race (NIH/OMB) White	NA Clinics n=6 Clinics
Race (NIH/OMB) More than one race	NA Clinics n=6 Clinics
Race (NIH/OMB) Unknown or Not Reported	NA Clinics n=6 Clinics
Region of Enrollment United States	16 Clinics n=6 Clinics
Number of inpatient pediatric oncology beds	25 beds n=6 Clinics
Number of annual pediatric oncology admissions	1091 admissions n=6 Clinics
Number of pediatric oncology ambulatory visits	8552 ambulatory visits n=6 Clinics
Number of total inpatient days	5640 days n=6 Clinics
Number of total Bone Marrow Transplant/Stem Cell	32 transplants n=6 Clinics

PRIMARY outcome

Timeframe: 2 years

Population: Number of participants is not available for this study, only clinic-level data collected.

To obtain rate of ambulatory central line associated blood stream infections in ambulatory patients

Outcome measures

Outcome measures
Measure	Usual Care Only n=16 Clinics Clinics using usual care only.	Usual Care + 70% Isopropyl Alcohol n=16 Clinics Clinics using usual care + 70% isopropyl alcohol.
Total Number of Central Line Associated Blood Stream Infections (CLABSI) Per Protocol	113 infections	84 infections
Total Number of Central Line Associated Blood Stream Infections (CLABSI) Intent-to-treat	123 infections	109 infections

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants is not available for this study, only clinic-level data collected.

To obtain rate of ambulatory Mucosal Barrier Injury central line-associated bloodstream infections (MBI-CLABSI)

Outcome measures

Outcome measures
Measure	Usual Care Only n=16 Clinics Clinics using usual care only.	Usual Care + 70% Isopropyl Alcohol n=16 Clinics Clinics using usual care + 70% isopropyl alcohol.
Total Number of Mucosal Barrier Injury Central Line-associated Bloodstream Infections (MBI-CLABSI) Per Protocol	14 infections	8 infections
Total Number of Mucosal Barrier Injury Central Line-associated Bloodstream Infections (MBI-CLABSI) Intent-to-treat	16 infections	10 infections

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants is not available for this study, only clinic-level data collected.

To obtain rate of ambulatory secondary bloodstream infections

Outcome measures

Outcome measures
Measure	Usual Care Only n=16 Clinics Clinics using usual care only.	Usual Care + 70% Isopropyl Alcohol n=16 Clinics Clinics using usual care + 70% isopropyl alcohol.
Total Number of Ambulatory Secondary Bloodstream Infections (Secondary BSI) Per Protocol	11 secondary bloodstream infections	0 secondary bloodstream infections
Total Number of Ambulatory Secondary Bloodstream Infections (Secondary BSI) Intent-to-treat	11 secondary bloodstream infections	0 secondary bloodstream infections

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants is not available for this study, only clinic-level data collected.

To obtain rate of ambulatory single positive blood culture (SPBC)

Outcome measures

Outcome measures
Measure	Usual Care Only n=16 Clinics Clinics using usual care only.	Usual Care + 70% Isopropyl Alcohol n=16 Clinics Clinics using usual care + 70% isopropyl alcohol.
Total Number of Ambulatory Single Positive Blood Cultures (SPBC) Per Protocol	29 single positive blood cultures	42 single positive blood cultures
Total Number of Ambulatory Single Positive Blood Cultures (SPBC) Intent-to-treat	36 single positive blood cultures	51 single positive blood cultures

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants is not available for this study, only clinic-level data collected.

To obtain rate of ambulatory positive blood culture rate

Outcome measures

Outcome measures
Measure	Usual Care Only n=16 Clinics Clinics using usual care only.	Usual Care + 70% Isopropyl Alcohol n=16 Clinics Clinics using usual care + 70% isopropyl alcohol.
Total Number of Ambulatory Positive Blood Culture Per Protocol	167 positive blood cultures	134 positive blood cultures
Total Number of Ambulatory Positive Blood Culture Intent-to-treat	186 positive blood cultures	170 positive blood cultures

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants is not available for this study, only clinic-level data collected.

Organism distribution of Gram positive bacteria, Gram negative bacteria, fungi, or other.

Outcome measures

Outcome measures
Measure	Usual Care Only n=16 Clinics Clinics using usual care only.	Usual Care + 70% Isopropyl Alcohol n=16 Clinics Clinics using usual care + 70% isopropyl alcohol.
Total Number of Acquired Pathogens Gram positive microorganisms	69 microorganisms	63 microorganisms
Total Number of Acquired Pathogens Gram negative microorganisms	72 microorganisms	75 microorganisms
Total Number of Acquired Pathogens Yeast	3 microorganisms	1 microorganisms
Total Number of Acquired Pathogens Mycobacterium	2 microorganisms	1 microorganisms
Total Number of Acquired Pathogens Other	0 microorganisms	0 microorganisms

Adverse Events

All Clinics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aaron Milstone

Johns Hopkins University

Phone: 443-287-8932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place