Trial Outcomes & Findings for Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections (NCT NCT01619410)

NCT ID: NCT01619410

Last Updated: 2019-11-08

Results Overview

Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.

Recruitment status

TERMINATED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

40 days after completion of treatment

Results posted on

2019-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Linezolid Linezolid: Linezolid 600 mg every 12 hours for 7 days	Clindamycin Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Overall Study STARTED	14	11
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Linezolid Linezolid: Linezolid 600 mg every 12 hours for 7 days	Clindamycin Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Overall Study Lost to Follow-up	7	4

Baseline Characteristics

Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Linezolid n=14 Participants Linezolid: Linezolid 600 mg every 12 hours for 7 days	Clindamycin n=11 Participants Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days	Total n=25 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 15.4 • n=5 Participants	40.5 years STANDARD_DEVIATION 11.9 • n=7 Participants	42.0 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 40 days after completion of treatment

Population: Only subjects returning for the 40-day outcome measurement were included in this analysis

Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.

Outcome measures

Outcome measures
Measure	Linezolid n=7 Participants Linezolid: Linezolid 600 mg every 12 hours for 7 days	Clindamycin n=7 Participants Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 7 days after completion of treatment

The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.

Outcome measures

Outcome measures
Measure	Linezolid n=10 Participants Linezolid: Linezolid 600 mg every 12 hours for 7 days	Clindamycin n=7 Participants Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days Cure	10 Participants	7 Participants
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days Treatment failure	0 Participants	0 Participants
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days Relapse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 40 days after completion of treatment

The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.

Outcome measures

Outcome measures
Measure	Linezolid n=9 Participants Linezolid: Linezolid 600 mg every 12 hours for 7 days	Clindamycin n=7 Participants Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days Cure	9 Participants	6 Participants
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days Treatment failure	0 Participants	0 Participants
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days Relapse	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 40 days after completion of treatment

Population: No data available due to samples being lost as a result of equipment issues.

The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups.

Outcome measures

Outcome data not reported

Adverse Events

Linezolid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clindamycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Z. David/Assistant Professor

University of Pennsylvania

Phone: 215-662-6932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place