Trial Outcomes & Findings for Preventing Staphylococcal (Staph) Infection (NCT NCT00108160)
NCT ID: NCT00108160
Last Updated: 2014-04-16
Results Overview
During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)
COMPLETED
PHASE4
146 participants
18 months
2014-04-16
Participant Flow
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.
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
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
63
|
|
Overall Study
Completed Visit 0 (Baseline)
|
79
|
60
|
|
Overall Study
Completed Visit 1 (2 Wks)
|
72
|
54
|
|
Overall Study
Completed Visit 2 (3 mo)
|
54
|
46
|
|
Overall Study
Completed Visit 3 (6 mo)
|
44
|
38
|
|
Overall Study
Completed Visit 4 (9 mo)
|
38
|
37
|
|
Overall Study
Completed Visit 5 (12 mo)
|
37
|
37
|
|
Overall Study
Completed Visit 6 (15 mo)
|
36
|
33
|
|
Overall Study
Completed Visit 7 (18 mo)
|
34
|
31
|
|
Overall Study
COMPLETED
|
44
|
42
|
|
Overall Study
NOT COMPLETED
|
39
|
21
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
12
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Protocol Violation
|
9
|
5
|
Baseline Characteristics
Preventing Staphylococcal (Staph) Infection
Baseline characteristics by cohort
| Measure |
Mupirocin Ointment (Treatment)
n=83 Participants
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)
n=63 Participants
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
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
n=5 Participants
|
57.9 years
n=7 Participants
|
57.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Baseline S. aureus Infection Strain
MRSA Infection at Baseline
|
53 participants
n=5 Participants
|
43 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Baseline S. aureus Infection Strain
MSSA Infection at Baseline
|
30 participants
n=5 Participants
|
20 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Re-infections with S. aureus, new or recurrent, were noted for all patients enrolled in the study and for patients who completed each study visit.
During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)
Outcome measures
| Measure |
Mupirocin Ointment (Treatment)
n=83 Participants
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)
n=63 Participants
Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
|
|---|---|---|
|
Re-infection With S. Aureus
All enrolled participants [n=83,63)]
|
10 participants with S. aureus re-infection
|
11 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
completed visit 3 (6 mo) [n=44,38]
|
2 participants with S. aureus re-infection
|
4 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
completed visit 5 (12 mo) [n=37,37]
|
0 participants with S. aureus re-infection
|
0 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
completed visit 7 (18 mo) [n=34,31]
|
1 participants with S. aureus re-infection
|
1 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
Completed visit 0 baseline [n=79,60]
|
0 participants with S. aureus re-infection
|
0 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
Completed visit 1 (2 wks) ([n=72,54]
|
1 participants with S. aureus re-infection
|
0 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
Completed visit 2 (3 mo) [n=54,46]
|
2 participants with S. aureus re-infection
|
3 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
completed visit 4 (9 mo) [n=38,37]
|
3 participants with S. aureus re-infection
|
1 participants with S. aureus re-infection
|
|
Re-infection With S. Aureus
completed visit 6 (15 mo) [n=36,33]
|
1 participants with S. aureus re-infection
|
2 participants with S. aureus re-infection
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Participants with S. aureus re-infection who acquired a new strain during the 18 month study period.
In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.
Outcome measures
| Measure |
Mupirocin Ointment (Treatment)
n=10 Participants
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)
n=11 Participants
Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
|
|---|---|---|
|
Acquisition of New S. Aureus Strains
Same strain baseline & Re-infection
|
10 participants
|
10 participants
|
|
Acquisition of New S. Aureus Strains
MRSA Baseline & Re-Infection
|
8 participants
|
10 participants
|
|
Acquisition of New S. Aureus Strains
MSSA Baseline & Re-Infection
|
2 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsThe anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared. S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection. Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.
Outcome measures
| Measure |
Mupirocin Ointment (Treatment)
n=10 Participants
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)
n=11 Participants
Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
|
|---|---|---|
|
S. Aureus Re-infections (New or Recurrent)
All Re-Infections
|
10 participants
|
11 participants
|
|
S. Aureus Re-infections (New or Recurrent)
Re-infections Different Anatomic Site
|
7 participants
|
6 participants
|
Adverse Events
Mupirocin Ointment
Polyethylene Glycol Ointment
Serious adverse events
| Measure |
Mupirocin Ointment
n=83 participants at risk
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
n=63 participants at risk
Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Underlying condition that led to death
|
0.00%
0/83 • Duration of the study - 18 months
A questionnaire was administered by study personnel at each visit. Patients who did not show for visits were contacted by phone and mail at regular intervals by study personnel. Chart reviews were conducted for patients who did not show or respond.
|
1.6%
1/63 • Number of events 1 • Duration of the study - 18 months
A questionnaire was administered by study personnel at each visit. Patients who did not show for visits were contacted by phone and mail at regular intervals by study personnel. Chart reviews were conducted for patients who did not show or respond.
|
|
Cardiac disorders
Underlying condition that led to death
|
1.2%
1/83 • Number of events 1 • Duration of the study - 18 months
A questionnaire was administered by study personnel at each visit. Patients who did not show for visits were contacted by phone and mail at regular intervals by study personnel. Chart reviews were conducted for patients who did not show or respond.
|
1.6%
1/63 • Number of events 1 • Duration of the study - 18 months
A questionnaire was administered by study personnel at each visit. Patients who did not show for visits were contacted by phone and mail at regular intervals by study personnel. Chart reviews were conducted for patients who did not show or respond.
|
Other adverse events
Adverse event data not reported
Additional Information
Suzanne F. Bradley, M.D.
VA Ann Arbor Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place