Active clinical trials for "Bacterial Infections"

The safety and tolerability of hLF 1-11 given in multiple doses has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal or bacterial disease. These patients are different from healthy volunteers because they have received myeloablative treatment, which not only arrests haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which predispose to infections, which typically occur during the week after transplant. It is therefore essential to know that hLF 1-11 is safe and well tolerated when given during neutropenia and mucosal barrier injury before infections ensue.

Ceramo metallic restoration has proved high success rate over past years as considered to be the gold standard while Monolithic zirconia as fixed dental prostheses have gained attention because of their good fracture strength, low wear of the enamel antagonist and pleasant color .Material composition will affect gingival health and biofilm formation which initiate caries and periodontal diseases.

This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.

Characterization of the single dose pharmacokinetics of AV-006 in healthy male and female subjects. Description of safety and tolerability of AV-006 in healthy subjects

There is evidence that the current dosing recommendations of ceftazidime in hemodialysis patients may not reach the critical pharmacokinetic/pharmacodynamics thresholds associated with maximal efficacy. The primary objective is to assess whether the standard doses of ceftazidime (1 or 2 g) administered at the end of the dialysis session (intermittent dialysis) allow to obtain a trough level equal or superior to 8 mg/L if the causative organism is not identified or 1 x the MIC if it is identified and its in vitro susceptibility to ceftazidime established. The secondary objectives will be (i) to assess whether a trough level equal or superior to 32 mg/L (if the causative organism is not identified) and 4 x its MIC (if identified and its in vitro susceptibility established) can be obtained; (ii) whether the criteria mentioned above also apply to the free fractions of ceftazidime; (iii) to assess whether reaching the desired free and total trough concentrations impacts the clinical outcome of the patient; (iv) to assess whether the main hemodialysis parameters impact on ceftazidime total and free serum concentrations; (v) to assess the impact of patient's residual renal function on the ceftazidime serum free and total concentrations; (vi) to assess the impact of potential drug-drug interactions on ceftazidime serum free and total concentrations; (vii) to assess how the MIC of the causative organism (if known) affects the expected effectiveness of ceftazidime. The study will be prospective and monocentric. Drug assay will be made High Performance Liquid Chromatography (HPLC) and UV photometric detection (confirmed by tandem mass spectrometry detection[HPLC-MS-MS]). Free concentration will be measured after separation by membrane sieving. The expected number of enrolled patients will be 20 (arbitrarily chosen but compatible with previous studies and the possibilities of the Institution in which the study will be performed. The standard dose of ceftazidime will be (i) a loading dose of 2 g followed by a maintenance dose of 1 g (the dose may be modified by the clinician in charge if deemed necessary and recorded accordingly). The data obtained will be used for pharmacokinetic modelling and population pharmacokinetics, followed by Monte-Carlo simulations to obtain population-wide predictions and to draw conclusions that could be applicable to a larger population.

Severe bacterial infections are associated with mortality of about 30%. Patients with moderate to severe bacterial infections given early and appropriate empirical antibiotic treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9. However only about 2/3 of patients worldwide are given early and appropriate empirical antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous treatment. TREAT is a computerized decision support system for antibiotic treatment in inpatients with common bacterial infections. TREAT is based on a state of the art stochastic model of the domain (a causal probabilistic network) and uses a cost benefit model for antibiotic treatment, including costs assigned to future resistance. It was tested in a randomized controlled trial in 3 countries and shown to improve the percentage of appropriate empirical antibiotic treatment while at the same time reduce hospital stay and the use of broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited information available within hours of presentation. A second attractive approach to improve antibiotic treatment is to use techniques that do not depend on cultures, and thus shorten the time to identification of the pathogen to a few hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid amplification test for pathogens causing bloodstream infections. The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will improve the outcome of inpatients with moderate to severe bacterial infections, while at the same time reducing the use of broad-spectrum antibiotics, with no or little additional costs. A secondary objective will be to assess the sensitivity and specificity of whole blood PCR, using TREAT as the reference standard.

Bone and joint infections (BJI) is a public health issue in industrialized countries. Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients. A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea). Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis. Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs. The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.

This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.

Silver nanoparticles are one of most nanoparticles use nowadays in the research area because it has specific physical and chemical properties, in medical fields silver nanoparticles can involve in diagnostic and treatment processes. Silver nanoparticles have antibacterial, antiviral, antifungal, antiangiogenic, antioxidant, cosmetics, antitumor, anti-inflammatory, the drug carrier, imaging, water treatment, and biosensing effects. Silver nanoparticles prepared with reducing agent tri-sodium citrate then incorporated in a topical cream to obtain a significant inhibition of the bacterial strains, inhibition of growth of bacterial strains in the face or other parts in the bodies.

The purpose of this study is to validate presepsin as a biological marker for identifying bacterial fever among febrile syndromes of infants under three months of age. Clearly, our goal is to determine if this marker can help us distinguish a viral infection from a bacterial infection. Indeed, presepsin would be specific for bacterial infection, and rise earlier in the blood during infection than biological markers currently used. Such validation could improve the precocity of the therapeutic management by a better targeted antibiotic therapy, and the limitation of invasive complementary examinations (lumbar puncture), in infants for whom the fear of a bacterial infection leads to examinations and systematic treatments.