Trial Outcomes & Findings for 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 (NCT NCT03030989)

NCT ID: NCT03030989

Last Updated: 2020-12-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2020-12-10

Participant Flow

Participant milestones

Measure	Chlorhexidine Gluconate 2% Wipe Chlorhexidine Gluconate 2% Wipe	Placebo Wipe Placebo Wipe
Overall Study STARTED	21	29
Overall Study COMPLETED	9	15
Overall Study NOT COMPLETED	12	14

Reasons for withdrawal

Measure	Chlorhexidine Gluconate 2% Wipe Chlorhexidine Gluconate 2% Wipe	Placebo Wipe Placebo Wipe
Overall Study Fever	2	2
Overall Study Rash	2	1
Overall Study Fatigue/Overwhelmed	1	5
Overall Study Positive Blood Cultures	2	1
Overall Study Line Removed	0	2
Overall Study No longer interested	5	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chlorhexidine Gluconate 2% Wipe n=21 Participants Chlorhexidine Gluconate 2% Wipe	Placebo Wipe n=29 Participants Placebo Wipe	Total n=50 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	61 years n=7 Participants	61.5 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	29 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Among all subjects enrolled.

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

Outcome measures

Measure	Chlorhexidine Gluconate 2% Wipe n=21 Participants Chlorhexidine Gluconate 2% Wipe	Placebo Wipe n=29 Participants Placebo Wipe
Number of Participants With Primary Blood Stream Infections	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Among all subjects enrolled.

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

Outcome measures

Measure	Chlorhexidine Gluconate 2% Wipe n=21 Participants Chlorhexidine Gluconate 2% Wipe	Placebo Wipe n=29 Participants Placebo Wipe
Number of Participants With Clinical (Culture-negative) Sepsis	0 Participants	0 Participants

Adverse Events

Chlorhexidine Gluconate 2% Wipe

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Wipe

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chlorhexidine Gluconate 2% Wipe n=21 participants at risk Chlorhexidine Gluconate 2% Wipe	Placebo Wipe n=29 participants at risk Placebo Wipe
Skin and subcutaneous tissue disorders Rash	9.5% 2/21 • 14 weeks	3.4% 1/29 • 14 weeks

Additional Information

Randee Estes, Study Coordinator

University of Chicago

Phone: 773-702-1209

Email: restes@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place