Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Trish Perl, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00549393
First received: October 24, 2007
Last updated: September 1, 2015
Last verified: September 2015
Results First Received: March 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Nosocomial Infections
Intervention: Drug: 2% Chlorhexidine gluconate cloth

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The hospital ICU units underwent a crossover study design, so the ICUs recruited participants under one intervention, then later switched to the other intervention for a separate population of participants recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow for 2 periods

Period 1:   Period 1
    2% Chlorhexidine Gluconate Cloth     Standard Bath  
STARTED     1319 [1]   1199 [2]
COMPLETED     1319     1199  
NOT COMPLETED     0     0  
[1] intention to treat (ITT)
[2] ITT

Period 2:   Period 2
    2% Chlorhexidine Gluconate Cloth     Standard Bath  
STARTED     1103 [1]   1326 [1]
COMPLETED     1103     1326  
NOT COMPLETED     0     0  
[1] number not equal to period 1 due to unit cross over design



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Arm

Daily bathing with 2% chlorhexidine gluconate

2% Chlorhexidine gluconate cloth: Daily bathing

Control Arm Standard bathing with soap and water basin or disposable cloth
Total Total of all reporting groups

Baseline Measures
    Treatment Arm     Control Arm     Total  
Number of Participants  
[units: participants]
  2422     2525     4947  
Age  
[units: years]
Median (Inter-Quartile Range)
  4.8  
  (1.1 to 12.9)  
  4.8  
  (1.1 to 12.7)  
  4.8  
  (1.1 to 12.9)  
Gender, Customized  
[units: participants]
     
Male     1389     1388     2777  
Female     1033     1137     2170  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     1271     1269     2540  
non-Caucasian     1151     1256     2407  
PRISM III Score [1]
[units: score]
Median (Inter-Quartile Range)
  5  
  (0 to 13)  
  5  
  (0 to 11)  
  5  
  (0 to 12)  
[1] Severity score that predicts mortality. Range 0 (lowest mortality risk) to 74 (highest mortality risk)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bacteremia   [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ]

2.  Secondary:   Central Line Associated-bloodstream Infection (CLABSI)   [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ]

3.  Other Pre-specified:   Bacteremia   [ Time Frame: duration of ICU stay, median 3 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Dr. Aaron Milstone
Organization: Johns Hopkins University
phone: 4106143917
e-mail: amilsto1@jhmi.edu


Publications of Results:

Responsible Party: Trish Perl, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00549393     History of Changes
Other Study ID Numbers: NA_00006799
Study First Received: October 24, 2007
Results First Received: March 31, 2015
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration