A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT03030989
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 28.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications	Drug: Chlorhexidine Gluconate 2% Wipe; Drug: Placebo Wipe	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 2, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chlorhexidine Gluconate 2% Wipe	Drug: Chlorhexidine Gluconate 2% Wipe
Placebo Comparator: Placebo wipe	Drug: Placebo Wipe

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Primary Blood Stream Infections [14 weeks]

   Blood stream infections are defined by the presence of bacteria in the blood

2. Number of Participants With Clinical (Culture-negative) Sepsis [14 weeks]

   Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant

• Age 18 and up

Exclusion Criteria:

• Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products

• Extensive open wounds

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 22, 2016

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT03030989
• Other Study ID Numbers: IRB16-1059
• First Posted: Jan 25, 2017
• Last Update Posted: Dec 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Arm/Group Title	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe
Arm/Group Description	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe
Period Title: Overall Study
STARTED	21	29
COMPLETED	9	15
NOT COMPLETED	12	14

Baseline Characteristics

Arm/Group Title	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe	Total
Arm/Group Description	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe	Total of all reporting groups
Overall Participants	21	29	50
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	63	61	61.5
Sex: Female, Male (Count of Participants)
Female	10 47.6%	13 44.8%	23 46%
Male	11 52.4%	16 55.2%	27 54%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 3.4%	1 2%
Not Hispanic or Latino	21 100%	28 96.6%	49 98%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 4.8%	0 0%	1 2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 28.6%	6 20.7%	12 24%
White	14 66.7%	23 79.3%	37 74%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%	29 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Primary Blood Stream Infections
Description	Blood stream infections are defined by the presence of bacteria in the blood
Time Frame	14 weeks

Outcome Measure Data

Analysis Population Description

Among all subjects enrolled.

Arm/Group Title	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe
Arm/Group Description	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe
Measure Participants	21	29
Count of Participants [Participants]	1 4.8%	2 6.9%

2. Primary Outcome

Title	Number of Participants With Clinical (Culture-negative) Sepsis
Description	Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood
Time Frame	14 weeks

Outcome Measure Data

Analysis Population Description

Among all subjects enrolled.

Arm/Group Title	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe
Arm/Group Description	Chlorhexidine Gluconate 2% Wipe	Placebo Wipe
Measure Participants	21	29
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	14 weeks
Arm/Group Title	Chlorhexidine Gluconate 2% Wipe		Placebo Wipe
Arm/Group Description	Chlorhexidine Gluconate 2% Wipe		Placebo Wipe
All Cause Mortality
	Chlorhexidine Gluconate 2% Wipe		Placebo Wipe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/29 (0%)
Serious Adverse Events
	Chlorhexidine Gluconate 2% Wipe		Placebo Wipe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Chlorhexidine Gluconate 2% Wipe		Placebo Wipe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		1/29 (3.4%)
Skin and subcutaneous tissue disorders
Rash	2/21 (9.5%)		1/29 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.