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

• ClinicalTrials.gov Identifier: NCT00352612
• Recruitment Status: Completed
• First Posted: July 14, 2006
• Results First Posted: May 13, 2013
• Last Update Posted: May 13, 2013
• Sponsor: Aaron Chen
• Collaborators: Thrasher Research Fund; Johns Hopkins University
• Information provided by (Responsible Party): Aaron Chen, Johns Hopkins University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Conditions: Staphylococcal Infection; Abscess; Staphylococcal Skin Infection; Folliculitis
• Interventions: Drug: clindamycin; Drug: cephalexin
• Enrollment: 200

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cephalexin	Clindamycin
Arm/Group Description	patients who received cephalexin	those who received clindamycin
Period Title: Overall Study
Started	100	100
Completed	100	100
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Group 1	Group 2	Total
Arm/Group Description		cephalexin arm	clindamycin arm	Total of all reporting groups
Overall Number of Baseline Participants		100	100	200
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	100 participants	100 participants	200 participants
	<=18 years	100 100.0%	100 100.0%	200 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	100 participants	100 participants	200 participants
	Female	55 55.0%	60 60.0%	115 57.5%
	Male	45 45.0%	40 40.0%	85 42.5%

Outcome Measures

1. Primary Outcome

Title	Clinical Improvement at the 48-72 Hour Clinical Follow-up
Description	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.
Time Frame	48-72 hour clinical follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cephalexin	Clindamycin
Arm/Group Description:	those patients who received cephalexin	those patients who received clindamycin
Overall Number of Participants Analyzed	100	100
Measure Type: Number; Unit of Measure: participants
	94	97

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Cephalexin	Clindamycin
Arm/Group Description	[Not Specified]	[Not Specified]
All-Cause Mortality
	Cephalexin	Clindamycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Cephalexin	Clindamycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/100 (0.00%)	0/100 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cephalexin	Clindamycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/100 (0.00%)	0/100 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Aaron Chen
• Organization: Johns Hopkins University
• Phone: 4109556143
• EMail: achen33@jhmi.edu

• Responsible Party: Aaron Chen, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00352612
• Other Study ID Numbers: NA_00003301
• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Results First Submitted: April 10, 2012
• Results First Posted: May 13, 2013
• Last Update Posted: May 13, 2013