Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection
|ClinicalTrials.gov Identifier: NCT00187759|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 7, 2015
|First Submitted Date ICMJE||September 15, 2005|
|First Posted Date ICMJE||September 16, 2005|
|Last Update Posted Date||May 7, 2015|
|Study Start Date ICMJE||November 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Cure of soft tissue infection.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00187759 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection|
|Official Title ICMJE||A Placebo Controlled, Randomized, and Blinded Study of Antibiotic Treatment of Patients With Uncomplicated Soft Tissue Infection|
|Brief Summary||This study is to determine whether antibiotic therapy is needed for patients with non-life threatening soft tissue infections. Most patients with these soft tissue infections are presently treated with antibiotics. Many of these infections resolve without proper antibiotic treatment. Treatment of patients with antibiotics after surgical drainage of an abscess may not be necessary and indiscriminate use of antibiotics may lead to colonization by drug-resistant organisms. Subsequent infection by drug resistant organisms may limit the choice of antibiotics in more complicated infections. A comparison between antibiotic treatment and no antibiotic treatment in surgically treated, uncomplicated soft tissue infections is needed to address this very important question.|
The Integrated Soft Tissue Infection Service (ISIS) Clinic at San Francisco General Hospital treats a large number of patients with soft tissue infections, and our data suggest that antibiotics may be overused for these infections. Most of these infections are treated by surgical drainage of an abscess (77%). When microbiologic cultures were performed, 88% of the abscesses were infected with Staphylococcus aureus (S. aureus), and 55% of the abscesses contained methicillin-resistant Staphylococcus aureus (MRSA). Recently, the high prevalence of MRSA infection has been documented in San Francisco and throughout the country. Presently, most patients are treated with antibiotics after drainage of the abscess. Our retrospective analysis found that 60% of these infections resolved without appropriate antibiotic treatment. These were patients infected with MRSA who were treated with an antibiotic that was not active against that organism. This implies that surgical drainage of these abscesses was probably the important treatment and antibiotic treatment was probably not necessary.
Unnecessary use of antibiotics has adverse consequences. Some patients have allergic reactions to antibiotics. Patients can develop serious gastrointestinal infections from antibiotic use. Antibiotics are costly. But most importantly, overuse of antibiotics may be the significant factor in the spread of antibiotic resistant organisms. The increased prevalence of MRSA has made it extremely difficult to treat patients with appropriate antibiotics in life threatening infections (i.e. bacterial endocarditis, osteomyelitis, and necrotizing soft tissue infections).
The experience in the ISIS Clinic has brought into question our present practice of antibiotic use in patients with surgically managed abscesses. Many surgeons practicing in the ISIS clinic believe that antibiotics have little or no effect on the clinical course of these uncomplicated infections. Elimination of antibiotic use for these uncomplicated infections would certainly simplify care for these patients. It is even possible that decreased antibiotic use may decrease the prevalence of MRSA colonization in this population. However, decreased prevalence of MRSA colonization will not be specifically addressed in this limited study. A randomized, prospective and blinded trial comparing standard antibiotic treatment with no treatment should help determine whether antibiotics are really needed for these infections.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Condition ICMJE||Soft Tissue Infections|
|Intervention ICMJE||Drug: cephalexin|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||March 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
SEVERITY: Complicated soft tissue infections must be of sufficient severity to anticipate five or more days of antibiotic therapy.
DEFINITION OF COMPLICATED (one or more of the following criteria must be met): Infection requires(ed) significant surgical intervention (such as debridement of devitalized tissue, drainage of abscess, removal of foreign body implicated in infection) at the time of enrollment.
DISEASE: Major Abscess (no open wound). The patient must have all of the following: i) Acute onset within seven days prior to enrollment. ii) Purulent drainage or purulent aspirate. iii) Erythema, induration, or tenderness. iv) Evidence of loculated fluid by physical examination, blind aspiration, or ultrasound that requires intervention (such as aspiration, incision and drainage, excision) at the time of enrollment.
2. A culture must be obtained at the time of enrollment. 3. Patients must be at least 18 years of age. 4. The patient must sign and date a Committee on Human Research-approved informed consent form.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00187759|
|Other Study ID Numbers ICMJE||ISIS placebo|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of California, San Francisco|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of California, San Francisco|
|Verification Date||May 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP