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Soft Tissue Infections clinical trials

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NCT ID: NCT00989872 Completed - Clinical trials for Methicillin-resistant Staphylococcus Aureus

Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers

Start date: n/a
Phase: Phase 1
Study type: Interventional

This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.

NCT ID: NCT00876850 Withdrawn - Clinical trials for Skin Structures and Soft Tissue Infections

Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Start date: July 2009
Phase: Phase 3
Study type: Interventional

A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

NCT ID: NCT00827541 Completed - Clinical trials for Intra-Abdominal Infections

Post-Authorization Study Evaluating Safety Of Tigecycline

HORUS
Start date: August 2008
Phase: N/A
Study type: Observational

This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.

NCT ID: NCT00785200 Completed - Clinical trials for Methicillin-resistant Staphylococcus Aureus

MRSA Colonization and Control in the Dallas County Jail

Start date: January 2009
Phase: N/A
Study type: Interventional

The goal of this 3-year project is to control the spread of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) in the Dallas County Jail. CA-MRSA is a bacterium spreading rapidly through healthy populations and becoming an epidemic in many regions of the U.S. Many people in the community are asymptomatically colonized by MRSA. There have been outbreaks of MRSA infections at prisons and jails. We will study the spread of MRSA in the jail to better understand how the bacteria are transmitted from person to person there and how we can prevent their transmission. All detainees asked to participate must give informed consent to do so; their privacy will be carefully protected. Detainees with a history of allergy to CHG will be excluded. Seventeen objects in the jail will be sampled for contamination with MRSA. Bacteria will be collected from all cultures obtained from patients with bacterial skin infections for 18 months in a part of the jail in order to determine how frequently these infections are caused by MRSA relative to other bacteria. A group of about 1500 adult detainees will be tested for colonization with MRSA in order to determine how commonly detainees carry the bacterium. A cluster-randomized 6-month study will be undertaken among these detainees and those who take their places when they leave the jail to determine if chlorhexidine (CHG)-containing disposable wash cloths for skin cleaning can decrease the prevalence of MRSA skin or nose colonization. Detainees receiving CHG cloths (about 500 detainees) will be compared to detainees receiving water-soaked cloths for skin cleaning (about 500 detainees) or no intervention (about 500 detainees). The primary outcome will be a difference in average colonization prevalence in detention tanks, which are discrete detention units housing detainees, comparing the usual care to the CHG-exposed tanks after 6 months of CHG cloth use. A secondary outcome will be a decrease in skin infections from any cause in the tanks receiving CHG compared with usual care. All of the MRSA isolates and a sample of the S. aureus isolates susceptible to methicillin from specimens colonizing or infecting detainees, as well as those contaminating surfaces and objects in the jail will be tested genetically in order to determine which strains of MRSA are present in the jail. This study may identify ways to stop the spread of MRSA among people in jails and prisons, as well as other places.

NCT ID: NCT00737269 Completed - Clinical trials for Surgical Wound Infection

A Complicated Skin and Soft-tissue Infection Patient Registry

Start date: June 2008
Phase: Phase 4
Study type: Observational

The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.

NCT ID: NCT00736554 Completed - Clinical trials for Bacterial Infections

What is the Prevalence of Methicillin-Resistant Staphylococcus Aureus in Skin and Soft Tissue Infections Presenting to the Emergency Departments of a Canadian Academic Health Care Center?

CA-MRSA
Start date: July 2008
Phase: N/A
Study type: Observational

Staphylococcus aureus is the most common bacteria responsible for skin, bone, and muscle infections. Recent studies from the United States have suggested that a type of this bacterium called methicillin resistant S. aureus (MRSA) has become dramatically more common, especially the community strain. However, Canadian data is still largely lacking. This study aims to determine the prevalence of community acquired (CA) MRSA among patients presenting with skin and soft tissue infections to the Urgent Care Center and Emergency Departments in London, Ontario. This will be determined by taking swabs at enrollment from patient's noses, throats, and sites of infection. Patients will be asked to complete a health questionnaire with the goal of identifying risk factors associated with CA-MRSA. Through follow-up swabs of participants' noses and throats at one and three months, the effects of treatment on patient's carrying MRSA will be determined. Results may be used to form guidelines for empirical S aureus treatment in the region, reducing possible morbidity and mortality from delayed or suboptimal treatment of CA-MRSA infections. Improved understanding of risk factors associated with MRSA infection in a Canadian setting, may also change the practice of physicians considering empiric antibiotic therapy for skin and soft tissue infections.

NCT ID: NCT00730028 Completed - Clinical trials for Staphylococcal Infection

Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. The study will occur in areas where community associated methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria. A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX, or placebo (contains no medication). Volunteers will be grouped based on the presence of cellulitis or abscess, whether the abscess can be surgically drained, and its size. The subject participation duration for this study is about 6 weeks.

NCT ID: NCT00658866 Completed - Clinical trials for Soft Tissue Infection

Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection

2007-005020-33
Start date: February 2008
Phase: Phase 4
Study type: Interventional

Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in the European Union for diabetic foot infections of the skin and soft tissue. Although its antimicrobial spectrum and activity against ESBL-strains are promising to treat infected ulcers associated with diabetes, there is a lack of data on tissue pharmacokinetics of ertapenem in this patient population. However, for antimicrobial efficacy it is important to show that the antibiotic achieves sufficient concentrations at the site of infection, i.e. in tissue. A recent clinical study by Burkhardt et al. (Journal of Antimicrobial Chemotherapy, 2006) using the microdialysis technique showed that the free tissue concentrations after a single dose of 1 g ertapenem are sufficient and adequate to kill most relevant bacteria, suggesting efficacy of ertapenem for soft tissue infections. It is well known that there is no accumulation of ertapenem in plasma after multiple doses of 1 g every 24 h in patients without significantly impaired renal function. The single dose study by Burkhardt et al. also suggests that only negligible drug accumulation can be expected in soft tissues of healthy young volunteers after multiple doses. However, it was shown for other antibiotics that tissue PK may be significantly different under pathologic conditions, leading to impaired penetration, but subsequent accumulation after multiple doses due to a longer tissue half life than in healthy volunteers. Since the properties of inflamed tissue may diverge from those of healthy tissue it is important to evaluate which concentrations of ertapenem are reached in inflamed tissue after multiple doses. Clinical study: In the present study we will measure the concentrations of ertapenem over time in plasma and infected tissue of 10 diabetes patients after multiple doses. The microdialysis technique will be used. The ertapenem concentrations will be measured in inflamed tissue and in non-inflamed subcutaneous tissue to identify the effect of inflammation on pharmacokinetics. The findings of the present study will help to confirm the efficacy of ertapenem for the indication of diabetic soft tissue infections.

NCT ID: NCT00595881 Completed - Abscess Clinical Trials

Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

Start date: July 2008
Phase: N/A
Study type: Observational

The purpose of this study is to determine if soft tissue infections in pediatric patients can be more accurately diagnosed (i.e. the presence of a drainable abscess) with the addition of bedside ultrasound to the clinical examination compared to the clinical examination alone.

NCT ID: NCT00475930 Completed - Clinical trials for Staphylococcus Aureus

Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates

Start date: May 2007
Phase: N/A
Study type: Interventional

Outbreaks of skin and soft tissue infections (SSTI) related to community associated Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene and shared equipment are often hard to avoid in a military training environment, often designed to simulate battlefield conditions. It has recently been demonstrated that military recruits colonized with MRSA may be at increased risk of developing SSTI. Studies in the hospital environment have shown that decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in the treated individuals and also in their inpatient unit as a whole. The investigators propose a randomized, double blind, placebo controlled trial to: 1. Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths, self-administered three times weekly, in preventing SSTI among recruits in military training facilities; and 2. Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of Staphylococcus aureus colonization among military recruits.