Trial Outcomes & Findings for Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection (NCT NCT00829686)

NCT ID: NCT00829686

Last Updated: 2017-06-09

Results Overview

improving wound without evidence of fever, worsening cellulitis or induration

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

7 days

Results posted on

2017-06-09

Participant Flow

Patients were recruited who presented to the ER with an uncomplicated skin abscess who met inclusion criteria and did not meet exclusion criteria. Informed consent was obtained.

Participant milestones

Participant milestones
Measure	No Intervention No antibiotic	Septra DS Septra DS (800/160) two pills PO BID x 7 days
Overall Study STARTED	13	18
Overall Study COMPLETED	13	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Intervention n=13 Participants No antibiotic	Septra DS n=18 Participants Septra DS (800/160) two pills PO BID x 7 days	Total n=31 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	13 Participants n=5 Participants	18 Participants n=7 Participants	31 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	33.4 years STANDARD_DEVIATION 2 • n=5 Participants	34.5 years STANDARD_DEVIATION 2 • n=7 Participants	34.3 years STANDARD_DEVIATION 2 • n=5 Participants
Age, Customized Age 18-25 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Customized Age 26-40 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized Age 41-65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	18 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

improving wound without evidence of fever, worsening cellulitis or induration

Outcome measures

Outcome measures
Measure	No Intervention n=13 Participants No antibiotic	Septra DS n=18 Participants Septra DS (800/160) two pills PO BID x 7 days
Clinical Improvement at 7 Days After Incision and Drainage	10 participants	14 participants

SECONDARY outcome

Timeframe: 30 days

recurrence of abscess in previous or new location within 30 days

Outcome measures

Outcome measures
Measure	No Intervention n=13 Participants No antibiotic	Septra DS n=18 Participants Septra DS (800/160) two pills PO BID x 7 days
Recurrence Rates	1 participants	0 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gillian Schmitz, MD

Wilford Hall Medical Center

Phone: 919-724-9185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place