Nosocomial Infections
Conditions
Keywords
intensive care unit, Healthcare associated infections (HAI), pediatric
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).
Interventions
Daily bathing
Sponsors
Sage Products, Inc.
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 25 Years
Healthy volunteers
No
Inclusion criteria
* Patients in pediatric intensive care unit
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteremia | participants were followed for the duration of ICU stay, median stay 3 days | incidence of bacteremia comparing those in treatment and control groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Line Associated-bloodstream Infection (CLABSI) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bacteremia | duration of ICU stay, median 3 days | per protocol analysis of incidence of bacteremia comparing those in treatment and control groups |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Daily bathing with 2% chlorhexidine gluconate
2% Chlorhexidine gluconate cloth: Daily bathing | 2,422 |
| Control Arm Standard bathing with soap and water basin or disposable cloth | 2,525 |
| Total | 4,947 |
Baseline characteristics
| Characteristic | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 4.8 years | 4.8 years | 4.8 years |
| PRISM III Score | 5 score | 5 score | 5 score |
| Race/Ethnicity, Customized Caucasian | 1271 participants | 1269 participants | 2540 participants |
| Race/Ethnicity, Customized non-Caucasian | 1151 participants | 1256 participants | 2407 participants |
| Sex/Gender, Customized Female | 1033 participants | 1137 participants | 2170 participants |
| Sex/Gender, Customized Male | 1389 participants | 1388 participants | 2777 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 2,422 | 26 / 2,525 |
| serious Total, serious adverse events | 0 / 2,422 | 0 / 2,525 |
Outcome results
Primary
Bacteremia
incidence of bacteremia comparing those in treatment and control groups
Time frame: participants were followed for the duration of ICU stay, median stay 3 days
Population: Intent to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Bacteremia | 3.52 events per 1000 at-risk days |
| Control Arm | Bacteremia | 4.93 events per 1000 at-risk days |
Secondary
Central Line Associated-bloodstream Infection (CLABSI)
Comparing incidence of central line-associated bloodstream infections between treatment and control groups
Time frame: participants were followed for the duration of ICU stay, median stay 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Central Line Associated-bloodstream Infection (CLABSI) | 1.63 events per 1000 at-risk days |
| Control Arm | Central Line Associated-bloodstream Infection (CLABSI) | 3.00 events per 1000 at-risk days |
Other Pre-specified
Bacteremia
per protocol analysis of incidence of bacteremia comparing those in treatment and control groups
Time frame: duration of ICU stay, median 3 days
Population: Includes per protocol population of 1547 of 2422 in the treatment arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Bacteremia | 3.28 events per 1000 at-risk days |
| Control Arm | Bacteremia | 4.93 events per 1000 at-risk days |