Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection

NCT00187759 | Completed

• 1 other identifier: ISIS placebo
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Infections

Keywords

Abscess; Antibitoics; Methicillin-resistant Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Cure of soft tissue infection.

Interventions

cephalexin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients must have a complicated skin or skin-structure infection that meets disease diagnostic criteria (severity, definition of complicated, and disease).
• 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.
• \. 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.

You may not qualify if:

• Any of the following conditions:
• Patients unlikely to survive through the treatment period and evaluations.
• Conditions such as toxic shock syndrome or toxic-like syndrome (Mandell et al. 2000), shock or hypotension (supine systolic blood pressure \<80 mmHg) refractory to fluid or short course pressor challenge (four hours or less) or oliguria (urine output \<20 mL/hr) not responsive to fluid challenge.
• Incisional wound that extends into visceral compartments.
• Suspected or proven contiguous bony or joint involvement.
• Malignant otitis externa.
• Ischemic ulcers or wounds associated with sever arterial insufficiency or gangrene.
• Infection of prosthetic materials or venous catheters that cannot be removed as part of the treatment of the current infection.
• Infection of a full-thickness burn wound or burn wound that is \>20% total body area.
• Surgical/nonsurgical debridement of devitalized tissue, removal of prosthetic material, incision and drainage, suture removal, percutaneous aspiration, packing, dressings, or irrigation (including with antibiotics) that cannot be instituted at the time of enrollment.
• Any known sensitivity to cephalexin.
• Patients with renal compromise.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Soft Tissue Infections; Abscess

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David M Young, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2004
• Study Completion: March 1, 2005
• Last Updated: May 7, 2015

Record last verified: 2015-05

Locations

US (1)