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Infection clinical trials

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NCT ID: NCT01241552 Completed - Clinical trials for Clostridium Difficile Infection

A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)

MODIFY I
Start date: October 10, 2011
Phase: Phase 3
Study type: Interventional

This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in participants receiving SOC therapy for CDI as compared to placebo.

NCT ID: NCT01238276 No longer available - Diabetic Foot Ulcer Clinical Trials

Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion

DAD
Start date: n/a
Phase:
Study type: Expanded Access

This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic solution and then dispersed using high-frequency external ultrasound. Using this system, a much higher concentration of antibiotic can be achieved than through traditional treatment methods. Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply and is beneficial for subjects with Diabetes or subjects who have received radiation therapy and blood supply is limited.

NCT ID: NCT01237730 Recruiting - Clinical trials for Prophylactic Antibiotics Before PEG

Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy

PEG
Start date: July 2010
Phase: N/A
Study type: Interventional

Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate

NCT ID: NCT01235546 Completed - Clinical trials for Surgical Site Infection

Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

C/SOAP
Start date: May 2011
Phase: N/A
Study type: Interventional

The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection. Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.

NCT ID: NCT01234389 Completed - H. Pylori Infection Clinical Trials

Immediate Detection of Helicobacter Infection With a New Electrochemical System.

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

Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT). The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.

NCT ID: NCT01232686 Completed - Clinical trials for Communicable Diseases

Snow Disease Surveillance System Study

Snow
Start date: October 2010
Phase: N/A
Study type: Interventional

The study investigates whether shared online access to epidemiological data for general practitioners, disease prevention officers, emergency care services and microbiology laboratories changes clinical practice with regard to testing, diagnosing and treatment of communicable diseases. The main hypothesis is that "online access for general practitioner to epidemiological data about communicable diseases changes clinical practice for testing, diagnosing and treatment of communicable diseases".

NCT ID: NCT01232595 Completed - Clinical trials for Moderate Clostridium Difficile Infection

Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections

Start date: October 2010
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.

NCT ID: NCT01231737 Enrolling by invitation - Clinical trials for Urinary Tract Infection

Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Start date: November 2010
Phase: Phase 2
Study type: Interventional

Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended. Aims of the study: 1. To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin): - in reducing the number of urinary tract infection episodes during prophylaxis - in reducing the number of urinary tract infection episodes after prophylaxis - in improving the patient's quality of life . 2. To assess : - Tolerability of antibiotic prophylaxis - The incidence of resistance to antibiotic therapy

NCT ID: NCT01231555 Terminated - Clinical trials for Infection, Human Immunodeficiency Virus

Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)

SIGNET
Start date: November 18, 2010
Phase: Phase 2
Study type: Interventional

This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets. Antiviral activity, safety, PK, and development of viral resistance will be evaluated.

NCT ID: NCT01231529 Completed - HIV Infections Clinical Trials

GSK1349572 Hepatic Impairment Study

Start date: November 19, 2010
Phase: Phase 1
Study type: Interventional

GSK1349572 is an integrase inhibitor that is currently in clinical development for the treatment of human immunodeficiency virus (HIV) infection. GSK1349572 is metabolized primarily by uridine diphosphate glucuronosyltransferase (UGT)1A1 with a minor role of Cytochrome P450 (CYP)3A. Hepatic impairment could potentially alter the clearance and plasma protein binding of GSK1349572. This study will evaluate the single dose pharmacokinetics and safety of GSK1349572 in healthy subjects and in subjects with mild or moderate hepatic impairment based on Child-Pugh category. This is a single-dose, open-label, parallel group, two-part, adaptive study in adult males and females with mild or moderate hepatic impairment and matched, healthy control subjects with normal hepatic function. Healthy control subjects (16) will be matched for gender, age, and BMI to the subjects in the mild (8) or moderate (8) hepatic impairment category. In Part 1, approximately 8 subjects with moderate hepatic impairment (cohort 1) and 8 matched, control subjects (cohort 2) will each receive GSK1349572 50 mg as a single dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in plasma. Free (unbound) plasma concentrations of GSK1349572 will also be evaluated at sparse, selected time points. If the geometric mean total plasma area under the concentration curve (AUC) of GSK1349572 is increased by > 2-fold in moderately impaired subjects compared to matched controls, Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in another group of subjects with mild impairment (8, cohort 3) and matched, control subjects (8, cohort 4). Vital signs, electrocardiograms (ECGs), and adverse events will be monitored throughout the study. A follow-up visit will occur 7-10 days after the dose of study drug.