Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187759
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2005-09-15
Brief Title:
Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Placebo Controlled Randomized and Blinded Study of Antibiotic Treatment of Patients With Uncomplicated Soft Tissue Infection
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None