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Communicable Diseases clinical trials

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NCT ID: NCT01033760 Completed - HIV-1 Infections Clinical Trials

Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.

NCT ID: NCT01032408 Completed - Clinical trials for H1N1 Influenza Virus

Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With HIV-1 Infection

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects. Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

NCT ID: NCT01031472 Completed - HIV Infections Clinical Trials

A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761

Start date: December 21, 2009
Phase: Phase 1
Study type: Interventional

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.

NCT ID: NCT01030731 Completed - Clinical trials for Staphylococcal Skin Infections

Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease

Start date: May 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers.

NCT ID: NCT01029717 Completed - Clinical trials for Catheter-related Infections

CATCH - Catheter Infections in Children

Start date: December 2010
Phase: Phase 3
Study type: Interventional

Most children admitted to paediatric intensive care units (PICU) need to have medicines given to them into their veins using a narrow tube, so they do not need repeated injections. This tube is called a central venous catheter. Occasionally these catheters can cause infections in the blood and sometimes the tubes can get blocked by small blood clots. Some intensive care units already use antibiotic or heparin coated catheters, but there is no proof that these are better than the standard ones at preventing infections. Most of the PICU's in this country use standard lines. The only way to find out for certain is to compare children who are given antibiotic or heparin coated catheters with those who are given standard ones in a clinical trial. Because we do not know which type of catheter is best, the type of catheter each child receives in the study will be decided randomly by chance. Each child in the trial will have the same chance of getting any of these three catheters: - Standard central venous catheter (not coated). - Heparin coated central venous catheter. Heparin is a medicine that can stop blood from clotting and might stop the tubes being blocked and infections in the blood. - Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria which cause the infections. The aim of this study is to see how the three types of catheters compare in reducing the amount of blood infections in children. We will also look at the costs involved. We hope to recruit 1200 children in the UK over 2 years. We hope that the information we get from this study will guide policy about purchasing impregnated Central Venous Catheters across the NHS and thereby improve treatment for children in the future.

NCT ID: NCT01028105 Terminated - Clinical trials for Methicillin-resistant Staphylococcus Aureus Infection

Incidence and Relationship of Positive Preoperative Methicillin Resistant Staphylococcus Aureus (MRSA) Screens and Post-operative Infections

MRSA
Start date: February 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the prevalence of pre-surgical patients who are MRSA carriers. From an evidence-based practice perspective, findings from this study can be considered in the evaluation of the hospital SOP mandating pre-surgical MRSA screening requirements for patients with scheduled surgeries. The central hypothesis to be addressed in this study is whether the MRSA colonization and subsequent post-operative infection are the equivalent in these populations.

NCT ID: NCT01026740 Completed - Clinical trials for Staphylococcal Skin Infections

Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers

Start date: June 2007
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration over time of ceftobiprole in these tissues and in plasma after administration of a single intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over 2 hours. The secondary objective was to further assess the safety and tolerability of ceftobiprole after a single i.v. infusion.

NCT ID: NCT01026636 Completed - Clinical trials for Staphylococcal Skin Infections

A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age

Start date: August 2007
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children.

NCT ID: NCT01026558 Completed - Obesity Clinical Trials

A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.

NCT ID: NCT01019889 Completed - Clinical trials for Upper Respiratory Tract Infections

Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection

ESYUI
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.