Trial · NCT00676130

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

NCT00676130, Not applicable, Completed, Brigham and Women's Hospital; results first posted 2012-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients. Trials, record NCT00676130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00676130

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
NCT number: NCT00676130
Status: Completed
Phases: Not applicable
Enrollment: 153 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Cellulitis
Interventions: trimethoprim-sulfamethoxazole, Cephalexin
First posted: 2008-05-12
Last updated: 2012-08-14
Results first posted: 2012-08-14

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Relative Efficacy	12 +/- 2 days; 30 +/- 2 days	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.
Secondary	Progression to Abscess	12 +/- 2 days, 30 days +/- 2 days	Proportion of subjects in each arm with progression from cellulitis to abscess.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Relative Efficacy	12 +/- 2 days; 30 +/- 2 days	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.	participants	NUMBER
SECONDARY	Progression to Abscess	12 +/- 2 days, 30 days +/- 2 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Relative Efficacy	Trimethoprim-sulfamethoxazole	62	participants
Relative Efficacy	Placebo	60	participants
Progression to Abscess	Trimethoprim-sulfamethoxazole	5	participants
Progression to Abscess	Placebo	5	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Trimethoprim-sulfamethoxazole	76
Overall Study	STARTED	Placebo	77
Overall Study	COMPLETED	Trimethoprim-sulfamethoxazole	73
Overall Study	COMPLETED	Placebo	73
Overall Study	NOT COMPLETED	Trimethoprim-sulfamethoxazole	3
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	Trimethoprim-sulfamethoxazole	21	73
other	Diarrhea	Gastrointestinal disorders	Placebo	25	73
other	Vomiting	Gastrointestinal disorders	Trimethoprim-sulfamethoxazole	5	73
other	Vomiting	Gastrointestinal disorders	Placebo	8	73
other	Nausea	Gastrointestinal disorders	Trimethoprim-sulfamethoxazole	15	73
other	Nausea	Gastrointestinal disorders	Placebo	13	73
other	Pruritis	Skin and subcutaneous tissue disorders	Trimethoprim-sulfamethoxazole	5	73
other	Pruritis	Skin and subcutaneous tissue disorders	Placebo	3	73
other	Rash	Skin and subcutaneous tissue disorders	Trimethoprim-sulfamethoxazole	5	73
other	Rash	Skin and subcutaneous tissue disorders	Placebo	3	73

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Trimethoprim-sulfamethoxazole
Total, all-cause mortality	Placebo
Total, other adverse events	Trimethoprim-sulfamethoxazole	36	73
Total, other adverse events	Placebo	39	73
Total, serious adverse events	Trimethoprim-sulfamethoxazole	0	73
Total, serious adverse events	Placebo	1	73

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23457080	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Trimethoprim-sulfamethoxazole vs Placebo: Relative Efficacy	Trial comparisons
Trimethoprim-sulfamethoxazole vs Placebo: Progression to Abscess	Trial comparisons
Trimethoprim-sulfamethoxazole vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00676130

GET https://conductscience.org/api/trials/v1/NCT00676130/registered

API reference For AI assistants