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NCT ID: NCT01411891 Completed - Catheter Infections Clinical Trials

Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch

Start date: August 2011
Phase: Phase 4
Study type: Interventional

Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per 10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030. Effective post-operative analgesia is an important component with regards to patient satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of thromboembolic disease in patients undergoing total knee or total hip replacement when compared with general anesthesia. Post-operatively, regional anesthesia has been shown to reduce pain scores and/or morphine consumption as well as opioid-related adverse effects. Epidural catheter or spinal anesthesia has become the standard of care at the University of Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still occasionally used for patients that would strongly prefer a general anesthetic, those that are taking anticoagulation medications or with a coagulopathy, those with previous back surgery, and those with certain neurologic conditions such as multiple sclerosis or spina bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters (FNC) for postoperative analgesia following TKA show no significant difference in pain scores, morphine consumption, or post-operative nausea and vomiting. However, epidural analgesia has been associated with higher incidence of hypotension and urinary retention. FNC's placed for postoperative pain allow patients to ambulate more effectively as there should not be much of a lower extremity motor block. Patients with a FNC for postoperative analgesia also do not require a urinary catheter which eliminates a common source of infection in postoperative patients. FNCs have also demonstrated improved rehabilitation times and decreased hospital stays which has led to an increased insertion rate of FNCs for postoperative analgesia following TKA at the University of Wisconsin. Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and 5.6% following revision TKA. Infection can be a devastating complication following implantation of joint hardware often leading to extended hospitalization/rehabilitation stays and return trips to the operating room. The average billed charges for all types of revision TKA procedures was $49,360 with average length of stay of 5.1 days. Indwelling lines are a known infection risk and indwelling lines in the femoral region are known to be associated with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al. found that 57% of FNCs placed without the use of a chlorhexidine impregnated patch had positive bacterial colonization. They also described three cases of transient bacteremia secondary to FNCs in the 208 catheters that they analyzed. Chlorhexidine impregnated patches also known as "biopatches" have been shown to reduce the incidence of bacterial colonization and infection of various indwelling lines including epidurals and central venous catheters. Currently no standard of care exists that requires the use of biopatches for FNCs. The investigators propose studying the use of the biopatch to reduce the incidence of bacterial colonization of femoral nerve catheters. The investigators will study the efficacy of the biopatch at decreasing the rate of bacterial colonization of FNCs in TKA patients. The FNCs will be inserted in the standard fashion and removed at the end of therapy. Typically the FNC infusion will continue until the morning of post-operation day (POD) #1 or 2. The process for FNC insertion first involves sterile prep and drape of the femoral region. Full sterile technique will be utilized including gown, gloves, and mask. Ultrasound guidance is then commonly utilized to identify the femoral nerve. Following patient sedation and skin infiltration with local anesthetic, a tuohy needle is inserted adjacent to the femoral nerve. A catheter is then threaded through the needle in close proximity to the femoral nerve. Patients will be randomized to either no chlorhexidine impregnated patch or to a chlorhexidine impregnated patch that will be located at the catheter exit site. On the morning of POD 1 or 2, the FNC infusion will be discontinued. Typically, Twenty-four to forty-eight hours after catheter insertion, it will be removed in a sterile fashion and the skin surrounding the catheter exit site will be swabbed and the distal catheter tip will be sent for culture to determine bacterial colonization. In addition, the investigators will interview patients and review clinical data to determine signs of infection and/or catheter tip colonization rates.

NCT ID: NCT01407016 Completed - Infection Clinical Trials

A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of metronidazole following single and multiple intravenous infusion in healthy Japanese adult subjects.

NCT ID: NCT01406587 Completed - Clinical trials for Urinary Tract Infection

Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

Start date: July 2011
Phase: Phase 2
Study type: Interventional

PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

NCT ID: NCT01402778 Completed - Infection Clinical Trials

Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

TDPAFD
Start date: January 2011
Phase: N/A
Study type: Observational

Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.

NCT ID: NCT01400867 Completed - Clinical trials for Infections, Pediatrics

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

Start date: December 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.

NCT ID: NCT01398969 Completed - Clinical trials for Clostridium Difficile Infection

Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.

NCT ID: NCT01396889 Completed - Clinical trials for Upper Respiratory Tract Infections

Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years

Start date: May 2010
Phase: N/A
Study type: Interventional

Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. The aim of this study is to evaluate its efficacy as prophilaxis in children 1-5 years old.

NCT ID: NCT01396798 Completed - Sepsis Clinical Trials

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.

ERNIE3
Start date: February 2011
Phase: N/A
Study type: Observational

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.

NCT ID: NCT01395290 Completed - Infection Clinical Trials

Vitamin D and Staphylococcus Aureus in the Diabetes Study

Start date: April 2011
Phase: Phase 3
Study type: Interventional

There are indications that the vitamin D status of an individual is related to susceptibility to staphylococcal infections. In the present study we will examine nasal colonisation rate in subjects participating in an ongoing vitamin D intervention study ( 20.000 IU cholecalciferol per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose tolerance.

NCT ID: NCT01394458 Completed - Bacteremia Clinical Trials

Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study

Start date: August 2011
Phase: N/A
Study type: Interventional

Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are "locked" into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use of an ethanol/sodium citrate locking solution may have advantages over either of these agents alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking solution is safe and effective in the prevention of catheter-related infections and thrombosis.