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

NCT00549393 | Completed Phase 2 Results

• 1 other identifier: NA_00006799
• Study Type: interventional
• Target: 5,659
• Locations: 1 country
• Sites: 5

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).

Conditions

Nosocomial Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bacteremia

  incidence of bacteremia comparing those in treatment and control groups

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

Secondary Outcomes (1)

• Central Line Associated-bloodstream Infection (CLABSI)

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

Other Outcomes (1)

• Bacteremia

  duration of ICU stay, median 3 days

Study Arms (2)

1

EXPERIMENTAL

Daily bathing with 2% chlorhexidine gluconate

Drug: 2% Chlorhexidine gluconate cloth

2

NO INTERVENTION

Standard bathing with soap and water basin or disposable cloth

Interventions

2% Chlorhexidine gluconate cloth DRUG

Daily bathing

1

Eligibility Criteria

• Age: 2 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients in pediatric intensive care unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sage Products, Inc.: collaborator

Study Sites (5)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 23363666 RESULT

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Aaron Milstone
• Organization: Johns Hopkins University

amilsto1@jhmi.edu

4106143917

Study Officials

• Trish M Perl, MD MSc

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Aaron Milstone, MD MHS

  Johns Hopkins University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 25, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2012
• Last Updated: June 14, 2017
• Results First Posted: October 2, 2015

Record last verified: 2017-05

Locations

US (5)