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=99 Participants
|
61 years
n=107 Participants
|
61.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
29 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: 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 weeksPopulation: 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place