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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00676130
First received: December 28, 2007
Last updated: August 12, 2012
Last verified: August 2012
Results First Received: July 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Cellulitis
Interventions: Drug: trimethoprim-sulfamethoxazole
Drug: Cephalexin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Trimethoprim-sulfamethoxazole Cephalexin plus trimethoprim-sulfamethoxazole
Placebo Cephalexin plus placebo

Participant Flow:   Overall Study
    Trimethoprim-sulfamethoxazole     Placebo  
STARTED     76     77  
COMPLETED     73     73  
NOT COMPLETED     3     4  
Lost to Follow-up                 0                 1  
Found ineligible                 3                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trimethoprim-sulfamethoxazole Cephalexin plus trimethoprim-sulfamethoxazole
Placebo Cephalexin plus placebo
Total Total of all reporting groups

Baseline Measures
    Trimethoprim-sulfamethoxazole     Placebo     Total  
Number of Participants  
[units: participants]
  76     77     153  
Age  
[units: participants]
     
<=18 years     3     5     8  
Between 18 and 65 years     68     69     137  
>=65 years     5     3     8  
Age  
[units: years]
Mean ± Standard Deviation
  37.03  ± 15.07     32.43  ± 15.15     34.71  ± 15.23  
Gender  
[units: participants]
     
Female     39     36     75  
Male     37     41     78  
Region of Enrollment  
[units: participants]
     
United States     76     77     153  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Relative Efficacy   [ Time Frame: 12 +/- 2 days; 30 +/- 2 days ]

2.  Secondary:   Progression to Abscess   [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Daniel J. Pallin, MD, MPH
Organization: Brigham and Women's Hospital
phone: 617-525-6614
e-mail: dpallin@partners.org


No publications provided by Brigham and Women's Hospital

Publications automatically indexed to this study:

Responsible Party: Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00676130     History of Changes
Other Study ID Numbers: 2007P000414, F8349839
Study First Received: December 28, 2007
Results First Received: July 3, 2012
Last Updated: August 12, 2012
Health Authority: United States: Institutional Review Board