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Bacterial Infections clinical trials

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NCT ID: NCT02993575 Completed - Clinical trials for Bacterial Infections

Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion to ICU Patients

FANATIC
Start date: June 1, 2017
Phase:
Study type: Observational

The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine total and free flucloxacillin concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion (n=20) of flucloxacillin as standard care. Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

NCT ID: NCT02992951 Recruiting - Wound Infection Clinical Trials

DACC in the REduction of Surgical Site INfection

DRESSINg
Start date: January 19, 2017
Phase: N/A
Study type: Interventional

Surgical site infection is an infection at a place in the body where surgery has taken place, and has been reported in around 5% of people undergoing an operation. In vascular surgery, infection rates are as high as 30%. Methods to reduce this rate of infection should be investigated thoroughly for their effectiveness and cost-effectiveness. The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts with, and binds bacteria, causing them to be mechanically removed from a wound when the dressing is changed. The trial aims to compare the effectiveness of this dressing to a standard, non-coated dressing, in the reduction of surgical site infection. 718 patients from a number of centres across the UK will be recruited to this study. Adult patients who are having a vascular surgery operation will be approached for entry into the trial. The trial will be explained to them, as well as an explanation that participation is voluntary and their operation or other aspects of their care will not be impacted in any way should participants not wish to participate. Participants will be randomised by computer into one of two groups - one group whose wounds are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard dressing. Patients will be followed up at 30 days post-operatively. At the follow up, their wounds will be inspected for infection, and participants will be asked to complete short questionnaires measuring quality of life. Quality of life will also be assessed at 3 months post surgery. The trial will aim to answer a number of questions, with the primary question being does a DACC coated dressing applied after an operation reduce the risk of an infection at the surgery site? It will also ask whether this treatment is cost-effective and whether it promotes satisfactory healing and evaluate the overall carbon footprint impact of each intervention. Studies Within a Trial will be conducted to validate a remote diagnostic measure for detecting surgical site infection using wound images and the Bluebelle Wound Healing Questionnaire, evaluate feasibility of novel hair removal methods such as epilation and waxing, carbon footprint modelling within randomised controlled trials.

NCT ID: NCT02988349 Completed - Dental Caries Clinical Trials

Ecological Effect of Arginine Dentifrice on Oral Microbiota

Start date: October 2013
Phase: N/A
Study type: Interventional

caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited. Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before and after the treatment for laboratory analyses.

NCT ID: NCT02979951 Recruiting - Sepsis Clinical Trials

Fosfomycin i.v. for Treatment of Severely Infected Patients

FORTRESS
Start date: December 2016
Phase:
Study type: Observational

The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.

NCT ID: NCT02962934 Completed - Clinical trials for Gram-Negative Bacterial Infections

An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT

CT-PK
Start date: November 30, 2016
Phase:
Study type: Observational

The purpose of this study is to try to find out how critically ill patients receiving the antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to study if the antibiotic concentrations during a dose of this antibiotic reaches the right concentrations necessary to kill the bacteria that is causing the infection. The process by which a drug travels through the body in blood, how it is broken down and removed by the body is called pharmacokinetics (PK). We can measure the PK by taking blood samples at specific times after the antibiotic is given. Investigators would like to do the study in patients receiving dialysis and patients who are not receiving dialysis. This information about how the antibiotic is processed in the critically ill patient is unknown and it is important to know whether the doses doctors give patients to fight infection are adequate. If antibiotic concentrations are low in the blood, it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to the antibiotic being less effective against bacteria potentially exposing future patients with infections to a limited range of effective antibiotics. Patients will be consented, and given the antibiotic as prescribed. Blood samples will be taken from the drip that is already in the patients arm just as the antibiotic starts, at 15 and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the blood samples taken from the dialysis machine before the blood reaches the dialysis filter (same blood samples as the non dialysis patients) and also bloods samples taken after the filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the dialysis process. The total amount of blood will be 40mls which is equal to about 2 tablespoons. The dialysis patient will have 50mls of blood taken.Information about the patients ICU stay will also be recorded.

NCT ID: NCT02955459 Completed - Clinical trials for Bacterial Infections

VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

NCT ID: NCT02931526 Recruiting - Critically Ill Clinical Trials

Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT)

Start date: August 2016
Phase: N/A
Study type: Observational

The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy(CRRT)and examine whether the dosage needs adjustment. The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.

NCT ID: NCT02914132 Completed - Bacteremia Clinical Trials

Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis

Start date: February 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.

NCT ID: NCT02898948 Completed - Fever Clinical Trials

Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine Department

PCT-MI
Start date: February 11, 2016
Phase:
Study type: Observational

Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1 for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells. Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other cytokines. PCT is used in critical care departments as a diagnostic marker, a guide to treatment (antibiotics are withdrawn if the level falls) and a prognostic marker. There are few data on the diagnostic use of PCT in an internal medicine department. The available studies yielded contradictory results and only one prospective study has been performed . The objective was to study PCT in non-infectious, inflammatory pathologies and to establish whether PCT could distinguish infections from other inflammatory pathologies in patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of 0.35 µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have been performed but featured small sample sizes and a retrospective design. Of the various studies performed in internal medicine departments, none included patients presenting with a suspected bacterial infection (according to the clinician's interpretation) and lacking information on their bacterial status. In fact, these diagnoses are a core component of hospitalisation in internal medicine departments for fever or inflammatory syndrome. The investigators intend to include all patients, including those lacking information on their microbiological status).

NCT ID: NCT02882568 Completed - Obesity Clinical Trials

Analysis of Immune Response In Bacterial Infection of Obese Subject

ARIIBO
Start date: August 2014
Phase: N/A
Study type: Interventional

Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude