Trial Outcomes & Findings for Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit (NCT NCT00549393)

NCT ID: NCT00549393

Last Updated: 2017-06-14

Results Overview

incidence of bacteremia comparing those in treatment and control groups

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

5659 participants

Primary outcome timeframe

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

Results posted on

2017-06-14

Participant Flow

The hospital ICU units underwent a crossover study design, so the ICUs recruited participants in the assigned treatment or control group, then the unit had a washout period, then the unit switched to the alternative assignment of intervention or control for a separate population of participants that were admitted into the ICU.

5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria

Participant milestones

Participant milestones
Measure	2% Chlorhexidine Gluconate Cloth Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Standard Bath Standard bathing with soap and water basin or disposable cloth
Period 1 (6 Months) STARTED	1319	1199
Period 1 (6 Months) Per Protocol	880	1199
Period 1 (6 Months) COMPLETED	1319	1199
Period 1 (6 Months) NOT COMPLETED	0	0
Period 2 Washout (2 Weeks) STARTED	0	0
Period 2 Washout (2 Weeks) COMPLETED	0	0
Period 2 Washout (2 Weeks) NOT COMPLETED	0	0
Period 3 (6 Months) STARTED	1103	1326
Period 3 (6 Months) Per Protocol	667	1326
Period 3 (6 Months) COMPLETED	1103	1326
Period 3 (6 Months) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=2422 Participants Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Control Arm n=2525 Participants Standard bathing with soap and water basin or disposable cloth	Total n=4947 Participants Total of all reporting groups
Age, Continuous	4.8 years n=5 Participants	4.8 years n=7 Participants	4.8 years n=5 Participants
Sex/Gender, Customized Male	1389 participants n=5 Participants	1388 participants n=7 Participants	2777 participants n=5 Participants
Sex/Gender, Customized Female	1033 participants n=5 Participants	1137 participants n=7 Participants	2170 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	1271 participants n=5 Participants	1269 participants n=7 Participants	2540 participants n=5 Participants
Race/Ethnicity, Customized non-Caucasian	1151 participants n=5 Participants	1256 participants n=7 Participants	2407 participants n=5 Participants
PRISM III Score	5 score n=5 Participants	5 score n=7 Participants	5 score n=5 Participants

PRIMARY outcome

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

Population: Intent to treat population

incidence of bacteremia comparing those in treatment and control groups

Outcome measures

Outcome measures
Measure	Treatment Arm n=2422 Participants Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Control Arm n=2525 Participants Standard bathing with soap and water basin or disposable cloth
Bacteremia	3.52 events per 1000 at-risk days Interval 2.64 to 4.61	4.93 events per 1000 at-risk days Interval 3.91 to 6.15

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=2422 Participants Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Control Arm n=2525 Participants Standard bathing with soap and water basin or disposable cloth
Central Line Associated-bloodstream Infection (CLABSI)	1.63 events per 1000 at-risk days Interval 0.87 to 2.79	3.00 events per 1000 at-risk days Interval 2.0 to 4.33

OTHER_PRE_SPECIFIED outcome

Timeframe: duration of ICU stay, median 3 days

Population: Includes per protocol population of 1547 of 2422 in the treatment arm

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=1547 Participants Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Control Arm n=2525 Participants Standard bathing with soap and water basin or disposable cloth
Bacteremia	3.28 events per 1000 at-risk days Interval 2.277 to 4.58	4.93 events per 1000 at-risk days Interval 3.91 to 6.15

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Arm n=2422 participants at risk Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Control Arm n=2525 participants at risk Standard bathing with soap and water basin or disposable cloth
Skin and subcutaneous tissue disorders Skin reaction	1.8% 43/2422 • Number of events 43 • participants were followed for the duration of ICU stay, median stay 3 days	1.0% 26/2525 • Number of events 26 • participants were followed for the duration of ICU stay, median stay 3 days

Additional Information

Dr. Aaron Milstone

Johns Hopkins University

Phone: 4106143917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place