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Communicable Diseases clinical trials

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NCT ID: NCT02269319 Completed - Clinical trials for Bacterial Infections

MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

ABSSSI
Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

NCT ID: NCT02266706 Completed - Clinical trials for Proven or Suspected Gram-negative Bacterial Infection

Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)

Start date: September 17, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In each of the 6 age cohorts, an interim analysis of pharmacokinetics (PK) and safety data was conducted after approximately 3 participants had received the initially proposed dose. The interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. However, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.

NCT ID: NCT02263703 Completed - Clinical trials for Inflammatory Bowel Disease

Immunogenicity of HPV Vaccine in Immunosuppressed Children

Start date: May 2007
Phase: Phase 3
Study type: Interventional

Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause of several other cancers and conditions. There are now effective vaccines against the main oncogenic HPV types, HPV16 and 18. Most research and discussion has focused on targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls commenced in 2007, in Australia. However, at the time of commencement, there had been no research on the use of this vaccine in immunosuppressed. Therefore, information on the immunogenicity, safety and duration of efficacy of HPV vaccine when administered to immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity, followed for 5 years for duration of immunity.

NCT ID: NCT02262819 Completed - Clinical trials for Staphylococcus Aureus Skin Infection

Human Immunity Against Staphylococcus Aureus Skin Infection

Start date: October 10, 2014
Phase: Phase 1
Study type: Interventional

Background: - Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory system. Sometimes people who get sick with staph infection do not get better with standard treatment. These staph infections can be serious and even deadly. Researchers want to find out why some people are more likely to get the infection. Objectives: - To look at the immune response of the skin when it is exposed to bacteria. Eligibility: - People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph infections. - Healthy volunteers. Design: - Participants will be screened with medical history, physical exam, and blood tests. - Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may have additional tests if needed. If they had a recent biopsy, researchers may ask for a sample from it. - Some participants will spend the night at the clinic. Their vital signs will be taken and they will have blood drawn. Some participants will take aspirin or ibuprofen starting 2 days before their stay. - Some participants will have blisters created on the inside of their forearm. Suction will pull a layer of skin from their arm. Skin will be removed. Different solutions will be applied to the blisters. Up to 3 biopsies may be taken. - Children will not have blood tests or biopsies. - Participants will be called every day for 10 days, then at 30 days after the procedure. - Participants will have a follow-up visit 10 days after the procedure. - Participants who did not get blisters or biopsies will not have any follow-up appointments.

NCT ID: NCT02260596 Completed - Clinical trials for Respiratory Viral Infection

Respiratory Viral Infections in Pediatric Transplantation

Start date: September 2014
Phase: N/A
Study type: Observational

A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients will be assembled to determine the incidence of respiratory viral infections diagnosed during an inpatient admission in the first year post-transplant. A sub-cohort of patients that develop a respiratory viral infection within one year of transplantation will be leveraged to investigate factors associated with mortality in the three months after respiratory viral infection.

NCT ID: NCT02254421 Completed - Clinical trials for Respiratory Syncytial Virus Infection

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

Start date: January 31, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

NCT ID: NCT02251717 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

Start date: October 14, 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

NCT ID: NCT02251262 Completed - Endocarditis Clinical Trials

Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection

ENDOTEP
Start date: June 22, 2015
Phase: N/A
Study type: Interventional

With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection. The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction. The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives. Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity. For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required. The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.

NCT ID: NCT02250274 Completed - Clinical trials for Influenza A Virus Infection

Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 years old. The effects of prior infection and or prior season vaccination will be examined. Children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).

NCT ID: NCT02249273 Completed - Clinical trials for Urinary Tract Infections

Diagnostic Tools in Patients With a Suspected Urinary Tract Infection in Primary Care

Start date: December 2014
Phase: N/A
Study type: Observational

Background: Inappropriate use of antibiotics is one of the main causes for the increase of antibiotic resistance strains. In Denmark general practice accounts for 90% of all prescribed antibiotics and one of the most common reasons for prescribing antibiotics is the suspicion of a urinary tract infection (UTI). The use of point-of-care test is meant to decrease the uncertainty about the bacterial origin of the symptoms; however, there is a paucity of knowledge about the validity of the different diagnostic approaches, thus impacting on the proper use of antibiotics. Objective: To assess the diagnostic validity of different diagnostic approaches in patients with a suspected urinary tract infection and assess the impact on appropriate use of antibiotics. Methods: 70 practices at the capital region will consecutively include 15-20 patients. The inclusion criteria of the patients comprise: a) Suspected Urinary tract infection, b) > 18 years of age, c) patient consulting during office hours. Data at patient and GP level will be gathered. 16 diagnostic approaches will be compared and proper use of antibiotics will be assessed as a two-step process. The first step is the decision made during the consultation and the second step is the decision made after the consultation. Sensitivity, specificity and predictive values will be measure for each diagnostic approach using urine culture as a gold standard. The impact on proper use of antibiotics will be assessed in a hierarchical multivariable logistic model.