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Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Primary Purpose

Nosocomial Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

2% Chlorhexidine gluconate cloth

About this trial

This is an interventional prevention trial for Nosocomial Infections focused on measuring intensive care unit, Healthcare associated infections (HAI), pediatric

Eligibility Criteria

2 Months - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients in pediatric intensive care unit

Exclusion Criteria:

Patients with a history of an allergic reaction to chlorhexidine
Patients less than 2 months of age
Patients with severe skin disease or burn
Patients with an indwelling epidural catheter or lumbar drain

Sites / Locations

Children's National Medical Center
Johns Hopkins Hospital
Saint Louis Children's Hospital
Children's Hospital of Philadelphia
Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Daily bathing with 2% chlorhexidine gluconate

Standard bathing with soap and water basin or disposable cloth

Outcomes

Primary Outcome Measures

Bacteremia

incidence of bacteremia comparing those in treatment and control groups

Secondary Outcome Measures

Central Line Associated-bloodstream Infection (CLABSI)

Comparing incidence of central line-associated bloodstream infections between treatment and control groups

Full Information

NCT ID

NCT00549393

First Posted

October 24, 2007

Last Updated

May 19, 2017

Sponsor

Johns Hopkins University

Collaborators

Sage Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00549393

Brief Title

Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Official Title

Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

Sage Products, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nosocomial Infections

Keywords

intensive care unit, Healthcare associated infections (HAI), pediatric

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5659 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Daily bathing with 2% chlorhexidine gluconate

Arm Title

Arm Type

No Intervention

Arm Description

Standard bathing with soap and water basin or disposable cloth

Intervention Type

Drug

Intervention Name(s)

2% Chlorhexidine gluconate cloth

Intervention Description

Daily bathing

Primary Outcome Measure Information:

Title

Bacteremia

Description

incidence of bacteremia comparing those in treatment and control groups

Time Frame

participants were followed for the duration of ICU stay, median stay 3 days

Secondary Outcome Measure Information:

Title

Central Line Associated-bloodstream Infection (CLABSI)

Description

Comparing incidence of central line-associated bloodstream infections between treatment and control groups

Time Frame

participants were followed for the duration of ICU stay, median stay 3 days

Other Pre-specified Outcome Measures:

Title

Bacteremia

Description

per protocol analysis of incidence of bacteremia comparing those in treatment and control groups

Time Frame

duration of ICU stay, median 3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients in pediatric intensive care unit Exclusion Criteria: Patients with a history of an allergic reaction to chlorhexidine Patients less than 2 months of age Patients with severe skin disease or burn Patients with an indwelling epidural catheter or lumbar drain

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trish M Perl, MD MSc

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Aaron Milstone, MD MHS

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Chair

Facility Information:

Facility Name

Children's National Medical Center

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Saint Louis Children's Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23363666

Citation

Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.

Results Reference

result

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Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

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