View clinical trials related to Infection.
Filter by:The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm. If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.
Rationale: Infection following total knee replacement (TKA) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce the rate of revisions due to implant loosening. Current controversy about the use of ABC exists around the world. Without a definitive trial, patients will be exposed to a treatment of uncertain efficacy that may cause antibiotic resistant bacterial strains and will certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent to which ABC compared to regular cement reduces the infection rate in patients over the first two years following TKA and, 2) the resource use implications associated with the use of ABC for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We will exclude patients with a prior joint infection, an allergy to tobramycin, and those with no fixed address. All patients will be administered IV antibiotics immediately prior to surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months postoperative. A blinded adjudicator will review all reported infections and determine whether the putative infection is a study event. Blinded radiologists will interpret the 2 year series of radiographs for each patient. We will compare the rates of infection and implant loosening between the two treatment groups using survival analyses. This study includes a full economic analysis.
The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.
Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5 years. Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIV-infected patients have been previously reported. The primary objective of the study was to evaluate the long-term efficacy and safety of subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months
This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection. The objectives are to determine the incidence of fracture among persons with and without HIV infection, compare risk factors for fracture among persons with and without HIV infection, and to examine the associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture among persons with HIV infection.
Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will be invited to participate. All study patients must receive treatment for CDI with metronidazole or vancomycin. Enrolled patients will be randomized in a 1:1 ratio to receive MIYA-BM Fines Granules [Clostridium butyricum MIYAIRI 588 Strain (CBM588)] or a placebo orally twice a day for 42 days. Patients will be evaluated for safety and clinical outcomes through Day 180. Occurrence of adverse events (AEs), diarrhea history, and concomitant medications will be evaluated at scheduled study visits and telephone contacts.
Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.
The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.
The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.
The purpose of this study is to collect pharmacokinetic (PK) information related to how well intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and tolerability of this new formulation. In addition, the PK, safety, and tolerability of switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be evaluated. The data collected in this study will be compared to data collected in previous studies. Individuals who have been diagnosed by their physicians with a blood disease or cancer that can affect their infection-fighting white blood cells will be asked to participate in the trial. Since these blood diseases and their treatments can weaken the immune system, they may put these individuals at a high risk for getting a serious fungal infection of their internal organs or blood (invasive fungal infection). As these fungal infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection. Enrollment into this study will take place in several stages (cohorts). The determination of which cohort an individual will be asked to participate in is based on which cohort is open at the site at the time the individual is approached to consider study participation.