Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT00676130

Recruitment Status : Completed

First Posted : May 12, 2008

Results First Posted : August 14, 2012

Last Update Posted : August 14, 2012

Sponsor:

Information provided by (Responsible Party):

Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Cellulitis
Interventions	Drug: trimethoprim-sulfamethoxazole Drug: Cephalexin
Enrollment	153

Participant Flow

Recruitment Details	We enrolled generally-healthy subjects with uncomplicated acute cellulitis from 6/2007 to 12/2011. Eligible subjects were adults and children presenting to EDs of 3 teaching hospitals in Boston, MA.
Pre-assignment Details	Each subject was assigned randomly to a treatment group by the institutions' research pharmacies. The research pharmacies had no knowledge of subjects' clinical characteristics. Treating (non-research) clinicians, research clinicians, coordinators, and subjects had no knowledge of the randomization sequence.


Arm/Group Title	Trimethoprim-sulfamethoxazole	Placebo
Arm/Group Description	Cephalexin plus trimethoprim-sulfam...	Cephalexin plus placebo
Arm/Group Description	Cephalexin plus trimethoprim-sulfamethoxazole	Cephalexin plus placebo
Period Title: Overall Study
Started	76	77
Completed	73	73
Not Completed	3	4
Reason Not Completed
Lost to Follow-up	0	1
Found ineligible	3	2
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		Trimethoprim-sulfamethoxazole	Placebo	Total
Arm/Group Description		Cephalexin plus trimethoprim-sulfam...	Cephalexin plus placebo	Total of all reporting groups
Arm/Group Description		Cephalexin plus trimethoprim-sulfamethoxazole	Cephalexin plus placebo	Total of all reporting groups
Overall Number of Baseline Participants		76	77	153
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	76 participants	77 participants	153 participants
	<=18 years	3 3.9%	5 6.5%	8 5.2%
	Between 18 and 65 years	68 89.5%	69 89.6%	137 89.5%
	>=65 years	5 6.6%	3 3.9%	8 5.2%
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	76 participants	77 participants	153 participants
		37.03 (15.07)	32.43 (15.15)	34.71 (15.23)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	76 participants	77 participants	153 participants
	Female	39 51.3%	36 46.8%	75 49.0%
	Male	37 48.7%	41 53.2%	78 51.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	76 participants	77 participants	153 participants
United States		76	77	153

Outcome Measures

1.Primary Outcome


Title	Relative Efficacy
Description	Proportion of subjects in each arm with successful treatment. ...
Description	Proportion of subjects in each arm with successful treatment. Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.
Time Frame	12 +/- 2 days; 30 +/- 2 days

Outcome Measure Data

Analysis Population Description

Of the 153 randomized subjects, 4 were randomized in error and did not receive study drug, 1 received two doses before it was discovered that he was ineligible, 1 was lost to follow up, and 1 withdrew voluntarily in the first few days after enrollment. This left 146 subjects for intent-to-treat analysis.


Arm/Group Title	Trimethoprim-sulfamethoxazole	Placebo
Arm/Group Description:	Cephalexin plus trimethoprim-sulfam...	Cephalexin plus placebo
Arm/Group Description:	Cephalexin plus trimethoprim-sulfamethoxazole	Cephalexin plus placebo
Overall Number of Participants Analyzed	73	73
Measure Type: Number Unit of Measure: participants
	62	60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trimethoprim-sulfamethoxazole, Placebo
	Comments	The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	2.7
	Confidence Interval	95% -9.3 to 15
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression to Abscess
Description	Proportion of subjects in each arm with progression from cellulitis to...
Description	Proportion of subjects in each arm with progression from cellulitis to abscess.
Time Frame	12 +/- 2 days, 30 days +/- 2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Trimethoprim-sulfamethoxazole	Placebo
Arm/Group Description:	Cephalexin plus trimethoprim-sulfam...	Cephalexin plus placebo
Arm/Group Description:	Cephalexin plus trimethoprim-sulfamethoxazole	Cephalexin plus placebo
Overall Number of Participants Analyzed	73	73
Measure Type: Number Unit of Measure: participants
	5	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trimethoprim-sulfamethoxazole, Placebo
	Comments	We assessed the rate of progression to abscess in the two groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95% -6.5 to 6.3
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	30 days, assessed via telephone contact, in-person visit, and medical record review.
Adverse Event Reporting Description	Serious adverse events were considered to be those resulting in hospital admission.

Arm/Group Title	Trimethoprim-sulfamethoxazole		Placebo
Arm/Group Description	Cephalexin plus trimethoprim-sulfam...		Cephalexin plus placebo
Arm/Group Description	Cephalexin plus trimethoprim-sulfamethoxazole		Cephalexin plus placebo
All-Cause Mortality
	Trimethoprim-sulfamethoxazole		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Trimethoprim-sulfamethoxazole		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0.00%)		1/73 (1.37%)
Gastrointestinal disorders
Clostridium difficile colitis ^†	0/73 (0.00%)	0	1/73 (1.37%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Trimethoprim-sulfamethoxazole		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/73 (49.32%)		39/73 (53.42%)
Gastrointestinal disorders
Diarrhea ^†	21/73 (28.77%)		25/73 (34.25%)
Vomiting ^†	5/73 (6.85%)		8/73 (10.96%)
Nausea ^*	15/73 (20.55%)		13/73 (17.81%)
Skin and subcutaneous tissue disorders
Pruritis ^*	5/73 (6.85%)		3/73 (4.11%)
Rash ^†	5/73 (6.85%)		3/73 (4.11%)
† Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Daniel J. Pallin, MD, MPH
Organization:	Brigham and Women's Hospital
Phone:	617-525-6614
EMail:	dpallin@partners.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pallin DJ, Binder WD, Allen MB, Lederman M, Parmar S, Filbin MR, Hooper DC, Camargo CA Jr. Clinical trial: comparative effectiveness of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone for treatment of uncomplicated cellulitis: a randomized controlled trial. Clin Infect Dis. 2013 Jun;56(12):1754-62. doi: 10.1093/cid/cit122. Epub 2013 Mar 1.

Layout table for additonal information

Responsible Party:	Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00676130
Other Study ID Numbers:	2007P000414 F8349839
First Submitted:	December 28, 2007
First Posted:	May 12, 2008
Results First Submitted:	July 3, 2012
Results First Posted:	August 14, 2012
Last Update Posted:	August 14, 2012

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