Trial Outcomes & Findings for Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections (NCT NCT00352612)

Results Overview

Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

48-72 hour clinical follow-up

Results posted on

2013-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Cephalexin patients who received cephalexin	Clindamycin those who received clindamycin
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=100 Participants cephalexin arm	Group 2 n=100 Participants clindamycin arm	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	60 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	40 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hour clinical follow-up

Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.

Outcome measures

Outcome measures
Measure	Cephalexin n=100 Participants those patients who received cephalexin	Clindamycin n=100 Participants those patients who received clindamycin
Clinical Improvement at the 48-72 Hour Clinical Follow-up	94 participants	97 participants

Adverse Events

Cephalexin

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

Aaron Chen

Johns Hopkins University

Phone: 4109556143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place