Trial Outcomes & Findings for Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection (NCT NCT00822692)

NCT ID: NCT00822692

Last Updated: 2015-12-21

Results Overview

Number of patient with a new abscess in same or different location as previous lesion

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 139 participants
• Primary outcome timeframe: 30 days after incision and drainage
• Results posted on: 2015-12-21

Participant Flow

Patients were enrolled at 3 hospital emergency departments from July 1, 2008 to June 1, 2009.

Patients were assigned by block randomization and data was analyzed with intention to treat analysis.

Participant milestones

Measure	Bactrim DS (800/160) Two Tablets PO BID x 7 Days Active Intervention Arm	Matched Placebo 2 Pills PO BID x 7 Days Placebo arm
Overall Study STARTED	63	76
Overall Study COMPLETED	46	51
Overall Study NOT COMPLETED	17	25

Reasons for withdrawal

Measure	Bactrim DS (800/160) Two Tablets PO BID x 7 Days Active Intervention Arm	Matched Placebo 2 Pills PO BID x 7 Days Placebo arm
Overall Study Lost to Follow-up	17	25

Baseline Characteristics

Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

Baseline characteristics by cohort

Measure	Bactrim DS (800/160) Two Tablets PO BID x 7 Days n=63 Participants Active Intervention Arm	Matched Placebo 2 Pills PO BID x 7 Days n=76 Participants Placebo arm	Total n=139 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants	76 Participants n=7 Participants	139 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.6 years STANDARD_DEVIATION 13 • n=5 Participants	30.6 years STANDARD_DEVIATION 13 • n=7 Participants	31.06 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	35 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	41 Participants n=7 Participants	86 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	76 participants n=7 Participants	139 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after incision and drainage

Number of patient with a new abscess in same or different location as previous lesion

Outcome measures

Measure	Bactrim DS (800/160) Two Tablets PO BID x 7 Days n=46 Participants Active Intervention Arm	Matched Placebo 2 Pills PO BID x 7 Days n=51 Participants Placebo arm
Recurrence Rates of Abscesses	4 participants	14 participants

Adverse Events

Bactrim DS (800/160) Two Tablets PO BID x 7 Days

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Matched Placebo 2 Pills PO BID x 7 Days

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bactrim DS (800/160) Two Tablets PO BID x 7 Days n=63 participants at risk bactrim DS (800/160) two tablets PO BID x 7 days	Matched Placebo 2 Pills PO BID x 7 Days n=76 participants at risk matched placebo 2 pills PO BID x 7 days
Skin and subcutaneous tissue disorders treatment failure	23.8% 15/63	35.5% 27/76

Additional Information

Gillian Schmitz, MD

Wilford Hall Medical Center

Phone: 919-724-9185

Email: gillianmd@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place