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Strategies To Prevent Pneumonia 2 (SToPP2) (SToPP2)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00893763
First received: May 4, 2009
Last updated: December 4, 2015
Last verified: December 2015
Results First Received: June 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Infections, Hospital
Ventilator-Associated Pneumonia
Mechanical Ventilation Complication
Interventions: Procedure: Pre-intubation CHX
Procedure: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from two large urban teaching medical centers (VCU Health System, Tampa General Hospital). Subjects were recruited in multiple clinical areas just prior to intubation, including critical care units, emergency departments, pre-operative areas, procedural areas, and medical-surgical units during rapid response or code calls.

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
1: Preintubation Oral Chlorhexidine Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
2: Control Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation

Participant Flow:   Overall Study
    1: Preintubation Oral Chlorhexidine     2: Control  
STARTED     157     157  
COMPLETED     47     47  
NOT COMPLETED     110     110  
extubated                 110                 110  



  Baseline Characteristics
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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.
Adults requiring endotracheal intubation

Reporting Groups
  Description
1: Preintubation Oral Chlorhexidine Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
2: Control Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Total Total of all reporting groups

Baseline Measures
    1: Preintubation Oral Chlorhexidine     2: Control     Total  
Number of Participants  
[units: participants]
  157     157     314  
Age  
[units: years]
Mean (Standard Deviation)
  58.08  (15.85)     58.20  (16.19)     58.12  (16.01)  
Gender  
[units: participants]
     
Female     66     98     164  
Male     91     59     150  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     5     4     9  
Not Hispanic or Latino     152     153     305  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     45     56     101  
White     106     96     202  
More than one race     6     5     11  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     157     157     314  



  Outcome Measures
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1.  Primary:   Development of VAP (Clinical Pulmonary Infection Score)   [ Time Frame: Baseline up to 5 days ]

2.  Secondary:   Endotracheal Tube Colonization   [ Time Frame: 24 hours ]

3.  Secondary:   Serum Cytokines   [ Time Frame: 5 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Serum Procalcitonin   [ Time Frame: 5 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Cindy L. Munro, APRN, PhD
Organization: University of South Florida
phone: 813-974-7597
e-mail: cmunro2@health.usf.edu


Publications of Results:

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00893763     History of Changes
Other Study ID Numbers: 2R01NR007652 ( US NIH Grant/Contract Award Number )
R01NR007652 ( US NIH Grant/Contract Award Number )
Study First Received: May 4, 2009
Results First Received: June 11, 2015
Last Updated: December 4, 2015
Health Authority: United States: Federal Government