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Infection clinical trials

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NCT ID: NCT00794703 Completed - Fungemia Clinical Trials

A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant 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: NCT00782158 Completed - HIV Infections Clinical Trials

Hepatitis B and HIV Co-Infection in Patients in Uganda

Start date: October 27, 2008
Phase:
Study type: Observational

This study will determine the amount of liver scarring (fibrosis) or liver damage in people infected with 1) hepatitis B virus (HBV, a virus that can infect the liver); 2) HIV (the virus that causes AIDS); 3) both HBV and HIV; and 4) neither HBV nor HIV. Liver fibrosis and liver damage can have many causes, including alcohol, certain medicines, exposure to some contaminated foods and infections with viruses that affect the liver (such as HBV). About 25 million people in sub-Saharan Africa are infected with HIV and about 50 million with chronic HBV, yet very little information is available on how many people are infected with both viruses and the medical implications of co-infection. Participants in Uganda s Rakai Health Sciences Program (RHSP) or Infectious Diseases Institute (IDI) clinic who are 18 years of age or older may be eligible for this study. People enrolled in the study come to the clinic for at least one visit and may be asked to return yearly. During the visit, participants undergo the following procedures: - Questionnaire and a short interview about their health and quality of life. - Physical examination and blood draw. The blood is tested for HBV and other factors that may suggest liver disease. Blood drawn at previous clinic visits or from other studies may also be tested. - Liver evaluation using a FibroScan, a medical device that uses elastic waves to measure liver stiffness in a process similar to ultrasound scanning. For this test, the subjects lies flat on the back with the arm extended out. The tip of the machine s probe is covered with gel and placed on the skin between the ribs at the level of the right lobe of the liver. The machine produces a little tap on the skin that sends a wave out and checks how fast the wave moves. The speed of the wave indicates the amount of scarring in the liver.

NCT ID: NCT00779246 Completed - Clinical trials for Staphylococcal Infections

Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections

Start date: June 2008
Phase: N/A
Study type: Interventional

This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).

NCT ID: NCT00776438 Completed - Influenza Clinical Trials

Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

Start date: September 2007
Phase: Phase 2
Study type: Interventional

To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: - To describe the immune response per age group and vaccine group after vaccination. - To describe the safety of the vaccines per age group and per vaccine group after vaccination.

NCT ID: NCT00775450 Completed - Influenza Clinical Trials

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Start date: October 2008
Phase: Phase 2
Study type: Interventional

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

NCT ID: NCT00775424 Completed - HIV Infection Clinical Trials

PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection

Start date: September 2008
Phase: Phase 1
Study type: Interventional

A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15. Primary objectives 1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B). 2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs when given with PENNVAX-B. Secondary objectives 1. To compare the various vaccine groups for their immunological responses to several HIV-1 antigens, utilizing the ELISPOT assay. 2. To analyze antibody responses to the vaccine antigens over time. 3. To measure CD8 cell proliferative responses to vaccine antigens over time.

NCT ID: NCT00775138 Completed - Bronchiectasis Clinical Trials

Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

Start date: June 24, 2008
Phase: Phase 2
Study type: Interventional

This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

NCT ID: NCT00772343 Completed - Diarrhea Clinical Trials

Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

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

Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care. Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.

NCT ID: NCT00772109 Completed - Influenza Clinical Trials

Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Start date: October 2008
Phase: Phase 3
Study type: Interventional

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: - To demonstrate lot consistency of the Fluzone ID manufacturing process. - To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety - To describe the safety profile of subjects who receive of Fluzone ID.