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NCT ID: NCT01441206 Terminated - Infection Clinical Trials

Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

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

The purpose of this study is to learn more about the safety and dosing of rifampin in infants.

NCT ID: NCT01396304 Terminated - Infection Clinical Trials

Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

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

Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.

NCT ID: NCT01381562 Terminated - Clinical trials for Infections, Intestinal

GSK2251052 in the Treatment of Complicated Intra-abdominal Infections

Start date: October 3, 2011
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cIAI.

NCT ID: NCT01381549 Terminated - Clinical trials for Infections, Urinary Tract

GSK2251052 in Complicated Urinary Tract Infection

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

This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

NCT ID: NCT01372943 Terminated - Clinical trials for Clostridium Difficile Infection

Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection

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

CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.

NCT ID: NCT01365312 Terminated - Sepsis Clinical Trials

Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates

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

Appropriate delivery of adequate nutrition and medications in premature infants often requires central venous access in the form of a special IV called a PICC (peripherally inserted central catheter). While a necessary feature of neonatal intensive care, PICCs pose significant risk: among the most serious of these is infection. One common, successful infection control practice used in older children and adults involves the use of a lock, in which a fluid-filled syringe is attached to the end of an IV when it is not in use in order to prevent and/or treat clotting or infection. The solution is left for some period of time and is then either withdrawn from the line or flushed into the patient. The solution could be saline, antibiotics, other antiseptics, or any combination of these. However in the premature infant, use of antibiotics as a locking compound risks leaving behind organisms resistant to treatment; antiseptics can irritate vessels and cause breakage to sensitive premature skin; saline has neither sterilization nor anti-infective properties. By contrast, ethanol neutralizes or kills most bacteria, viruses, and fungi without the risk of resistance, and because it is not externally applied there is no risk to baby skin. Ethanol-based lock protocols have been used safely and effectively in both adult and pediatric populations without adverse effects, but this has not been tested in premature babies because fluids and medication are delivered continuously: placement of a lock traditionally requires an extended pause (hours or days) in fluid and medication administration. To overcome these key limitations, a periodic, brief ethanol lock protocol was designed such that both infant exposure and interruptions to fluid and medication delivery would be minimized. The lock is practical, cheap, easy to place, and takes advantage of an existing daily pause during which IV tubing and fluids hooked up to the PICC are changed. The objective of this study is to test the hypothesis that use of a 70% ethanol lock, every 3rd day, for 15 minutes, will safely and effectively reduce PICC infection in our unit.

NCT ID: NCT01315418 Terminated - Sinusitis Clinical Trials

Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

Start date: December 2006
Phase: N/A
Study type: Interventional

This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.

NCT ID: NCT01291264 Terminated - Clinical trials for Sexually Transmitted Diseases

Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]

Start date: June 2012
Phase: Phase 4
Study type: Observational

Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG], using urine samples and swabs from the throat and rectum of men who have sex with men [MSM]. Using this test on these swabs is experimental because it has not been approved by the Food & Drug Administration.

NCT ID: NCT01290237 Terminated - Infection Clinical Trials

Use of a Loading Dose of Vancomycin in Pediatric Dosing

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

Vancomycin is an antibiotic administered to children or adults for many types of infections. While it has been used to treat infections of children for more than 50 years we are still not completely certain about the best dose to use when starting treatment with this medication. This study is intended to evaluate whether giving a new higher dose of vancomycin for the first dose will help us get to the desired amount in the body more quickly then the usual first dose. Half of the patients would get the new higher dose and the other half of patients will get the typical first dose. Only the first dose is changed and all doses that follow are the same in both groups and are doses typically used for children.

NCT ID: NCT01287013 Terminated - Cancer Clinical Trials

Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

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

Background: - Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite (GPS) device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach. Objectives: - To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure. Eligibility: - Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure. Design: - Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment. - After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking. - Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method. - Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method. - Standard post-procedure followup care will be given after the study procedure is completed.