Trial Outcomes & Findings for Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients (NCT NCT00676130)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

12 +/- 2 days; 30 +/- 2 days

Results posted on

2012-08-14

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Trimethoprim-sulfamethoxazole Cephalexin plus trimethoprim-sulfamethoxazole	Placebo Cephalexin plus placebo
Overall Study STARTED	76	77
Overall Study COMPLETED	73	73
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Trimethoprim-sulfamethoxazole Cephalexin plus trimethoprim-sulfamethoxazole	Placebo Cephalexin plus placebo
Overall Study Lost to Follow-up	0	1
Overall Study Found ineligible	3	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trimethoprim-sulfamethoxazole n=76 Participants Cephalexin plus trimethoprim-sulfamethoxazole	Placebo n=77 Participants Cephalexin plus placebo	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants	69 Participants n=7 Participants	137 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age Continuous	37.03 years STANDARD_DEVIATION 15.07 • n=5 Participants	32.43 years STANDARD_DEVIATION 15.15 • n=7 Participants	34.71 years STANDARD_DEVIATION 15.23 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	77 participants n=7 Participants	153 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 +/- 2 days; 30 +/- 2 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Trimethoprim-sulfamethoxazole n=73 Participants Cephalexin plus trimethoprim-sulfamethoxazole	Placebo n=73 Participants Cephalexin plus placebo
Relative Efficacy	62 participants	60 participants

SECONDARY outcome

Timeframe: 12 +/- 2 days, 30 days +/- 2 days

Proportion of subjects in each arm with progression from cellulitis to abscess.

Outcome measures

Outcome measures
Measure	Trimethoprim-sulfamethoxazole n=73 Participants Cephalexin plus trimethoprim-sulfamethoxazole	Placebo n=73 Participants Cephalexin plus placebo
Progression to Abscess	5 participants	5 participants

Adverse Events

Trimethoprim-sulfamethoxazole

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trimethoprim-sulfamethoxazole n=73 participants at risk Cephalexin plus trimethoprim-sulfamethoxazole	Placebo n=73 participants at risk Cephalexin plus placebo
Gastrointestinal disorders Clostridium difficile colitis	0.00% 0/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.	1.4% 1/73 • Number of events 1 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.

Other adverse events

Other adverse events
Measure	Trimethoprim-sulfamethoxazole n=73 participants at risk Cephalexin plus trimethoprim-sulfamethoxazole	Placebo n=73 participants at risk Cephalexin plus placebo
Gastrointestinal disorders Diarrhea	28.8% 21/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.	34.2% 25/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.
Gastrointestinal disorders Vomiting	6.8% 5/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.	11.0% 8/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.
Gastrointestinal disorders Nausea	20.5% 15/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.	17.8% 13/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.
Skin and subcutaneous tissue disorders Pruritis	6.8% 5/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.	4.1% 3/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.
Skin and subcutaneous tissue disorders Rash	6.8% 5/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.	4.1% 3/73 • 30 days, assessed via telephone contact, in-person visit, and medical record review. Serious adverse events were considered to be those resulting in hospital admission.

Additional Information

Daniel J. Pallin, MD, MPH

Brigham and Women's Hospital

Phone: 617-525-6614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place