Preventing Staphylococcal (Staph) Infection

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
Saint Joseph Mercy Health System
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108160
First received: April 14, 2005
Last updated: March 20, 2014
Last verified: March 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Staphylococcal Infections
Interventions: Drug: Mupirocin Ointment [Treatment]
Drug: Polyethylene Glycol Ointment [Placebo]

  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
Patients with a history of documented infection with Staphylococcus aureus cared for at Veterans Affairs Ann Arbor Healthcare System, University of Michigan Medical Center, St. Joseph Mercy Hospital (Ypsilanti, MI), and Pittsburgh VA Medical Center from April 2005-August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who met study criteria and signed an informed consent were enrolled and randomized to treatment with mupirocin 2% in polyethylene glycol (PEG) ointment or treatment with a placebo (polyethylene glycol) ointment

Reporting Groups
  Description
Mupirocin Ointment (Treatment) Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
Polyethylene Glycol Ointment (Placebo) Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.

Participant Flow:   Overall Study
    Mupirocin Ointment (Treatment)     Polyethylene Glycol Ointment (Placebo)  
STARTED     83     63  
Completed Visit 0 (Baseline)     79 [1]   60 [2]
Completed Visit 1 (2 Wks)     72     54  
Completed Visit 2 (3 mo)     54     46  
Completed Visit 3 (6 mo)     44     38  
Completed Visit 4 (9 mo)     38     37  
Completed Visit 5 (12 mo)     37     37  
Completed Visit 6 (15 mo)     36     33  
Completed Visit 7 (18 mo)     34     31  
COMPLETED     44 [3]   42 [4]
NOT COMPLETED     39     21  
Lost to Follow-up                 25                 12  
Death                 1                 2  
Withdrawal by Subject                 4                 2  
Protocol Violation                 9                 5  
[1] 4 patients who signed consent and were randomized did not complete the initial visit to start drug
[2] 3 patients who signed a consent and were randomized did not complete the initial visit to start drug
[3] Patients who completed 18 months of mupirocin or developed new (recurrent) S. aureus infection.
[4] Participants who completed 18 months of placebo or developed new (recurrent) S. aureus infection.



  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.
No text entered.

Reporting Groups
  Description
Mupirocin Ointment (Treatment) Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Treatment Group).
Polyethylene Glycol Ointment (Placebo) Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Placebo Group).
Total Total of all reporting groups

Baseline Measures
    Mupirocin Ointment (Treatment)     Polyethylene Glycol Ointment (Placebo)     Total  
Number of Participants  
[units: participants]
  83     63     146  
Age  
[units: years]
Mean ( Full Range )
  56.7  
  ( 25 to 88 )  
  57.9  
  ( 22 to 80 )  
  57.2  
  ( 22 to 88 )  
Gender  
[units: participants]
     
Female     4     9     13  
Male     79     54     133  
Baseline S. aureus Infection Strain  
[units: participants]
     
MRSA Infection at Baseline     53     43     96  
MSSA Infection at Baseline     30     20     50  



  Outcome Measures
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1.  Primary:   Re-infection With S. Aureus   [ Time Frame: 18 months ]

2.  Secondary:   Acquisition of New S. Aureus Strains   [ Time Frame: 18 months ]

3.  Other Pre-specified:   S. Aureus Re-infections (New or Recurrent)   [ Time Frame: 18 months ]


  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
The study is underpowered to detect differences between the two treatment arms. We achieved only 75% of target enrollment, and 41.1% dropped out before reaching a primary endpoint. Our re-infection rate was also lower than anticipated (14.4%).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Suzanne F. Bradley, M.D.
Organization: VA Ann Arbor Healthcare System
phone: 734-845-5820 ext 55826
e-mail: sbradley@umich.edu


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108160     History of Changes
Other Study ID Numbers: CLNB-001-04S
Study First Received: April 14, 2005
Results First Received: December 16, 2013
Last Updated: March 20, 2014
Health Authority: United States: Federal Government