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Bacterial Infections clinical trials

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NCT ID: NCT05645757 Completed - Bacterial Infection Clinical Trials

Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)

Start date: April 19, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107) alone in 52 healthy adult male and female subjects aged 18 to 45 years old (both inclusive). Seven treatment cohorts will be evaluated in this study. WCK 6777 will be evaluated in three cohorts - Cohorts 1, 4 and 7- of 8 subjects each (6 study drug combinations and 2 placebos); ERT will be evaluated alone in two cohorts - Cohorts 2 and 5- of 8 subject each (6 ERT and 2 placebos); and ZID will be evaluated in two cohorts, Cohorts 3 and 6, of 6 subjects each (all ZID). The study will be placebo-controlled and double-blinded in all cohorts except Cohorts 3 and 6. No placebo subjects are included in standalone ZID cohorts, since adequate safety data for higher doses of ZID alone in comparison with placebo are available from completed Phase 1 studies of WCK 5107 (ZID) alone and the ZID-only arms of WCK 5222 (cefepime + ZID) studies. The primary objective is to assess the safety and tolerability of three dose-escalating regimens of WCK 6777 ( ERT and ZID combination) and two-dose escalating regimens of standalone ERT or ZID following single daily doses for 7 days in healthy adult subjects.

NCT ID: NCT05614895 Completed - Clinical trials for Bacterial Infections

A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections

Start date: December 3, 2022
Phase: Phase 1
Study type: Interventional

The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.

NCT ID: NCT05586438 Completed - Clinical trials for Bacterial Infections

Pharmacokinetics of Colistin in Critically-ill Patients With AKI Who Receive SLED

Start date: October 18, 2021
Phase: Phase 4
Study type: Interventional

Colistin was developed in the 1960s and preliminary pharmacokinetic studies were performed at that time. Dosing recommendations, on the basis of these pharmacokinetic studies, are listed in the drug's product information. However, there are no optimal dosing recommendations for patients with acute kidney injury who receive sustained low-efficiency dialysis. Furthermore, the science of antibiotic dosing ("pharmacodynamics") has changed significantly since the 1960s and it is quite possible that the dosing recommendations listed in the product information are not optimal. Furthermore, even though physicians refer to "colistin" administration, the only intravenous form of the drug is colistin methanesulfonate (CMS). CMS is converted in the body to colistin. Both CMS and colistin have different pharmacokinetic and antimicrobial activities. For this reason, we, the investigators at the Mahidol university, are performing a pharmacokinetic study of the intravenous CMS/colistin in patients requiring sustained low-efficiency dialysis. Plasma concentrations will be determined around a CMS/colistin dose once the drug has reached steady state. Microbiologic and clinical endpoints will be determined and will be correlated with these concentrations. The measurement of CMS and colistin levels will be determined by a laboratory in Australia.

NCT ID: NCT05584982 Completed - Cystic Fibrosis Clinical Trials

Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis

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

This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.

NCT ID: NCT05581017 Completed - Clinical trials for Surgical Site Infection

Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy

Start date: June 16, 2020
Phase:
Study type: Observational

Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.

NCT ID: NCT05498363 Completed - Clinical trials for Bacterial Infections

Bacteriophage Therapy of Difficult-to-treat Infections

BT100
Start date: January 1, 2008
Phase:
Study type: Observational

A retrospective, observational analysis of the first one hundred consecutive cases of bacteriophage therapy of difficult-to-treat infections, facilitated by a Belgian consortium.

NCT ID: NCT05475444 Completed - Clinical trials for Bacterial Infections Oral

PLGA Nanoparticles Entrapping Ciprofloxacin to Treat E-Fecalis Infections in Endodontics

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

PLGA nanoparticles coated with Chitosan polymer were prepared and then incorporated in In -situ gel to be injected to root canals of patients suffered from bacterial infection of their endodontics.

NCT ID: NCT05361278 Completed - Dental Caries Clinical Trials

Evaluation of Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The process of removing bacteria and their products from the root canals is an essential step that is achieved through the combination of mechanical preparation and irrigation with chemicals. However, mechanical preparation alone can not reduce the microbial formations inside root canals, so at least about 35% of the root canal walls remain without the preparation tools reaching them. Many irrigants were used to irrigate the root canals, as sodium hypochlorite and chlorhexidine are the most famous. Although most studies have proven the effectiveness of sodium hypochlorite with its different concentrations in accomplishing this task, some of them showed the inability of the irrigant fluid to eliminate Enterococcus faecalis inside the canals. These bacteria are highly resistant, and therefore endodontic treatment fails in the long term.

NCT ID: NCT05353634 Completed - Clinical trials for Bacterial Infections and Mycoses

Metagenomic Sequencing in Clinical Infectious Diseases

Start date: June 10, 2020
Phase:
Study type: Observational

Progress in the diagnosis of infectious pathogens depends on the development of effective methods and the discovery of suitable biomarkers. There are several kinds of methods that have been used in diagnosis of various pathogens, such as microscopic examination, culture, serologic diagnosis or molecular approaches, etc. However, these methods have similar limitations, that is, the single detection of reagents. More importantly, physicians seldom consider infections with rare pathogens. Recently developed metagenomic next-generation sequencing (mNGS) has the capability to overcome limitations of traditional diagnostic tests. This new technology could identify all pathogens directly from sample with a single run in a hypothesis-free and culture-independent manner. Studies have shown that mNGS is more sensitive than traditional culture method in clinical conditions such as blood stream, respiratory and general infections. More importantly, due to unbiased sampling, mNGS is theoretically able to identify not only known but also unexpected pathogens or even discovery novel organisms. It should be noted that mNGS also has some limitations such as human genome contamination and possibly environmental microbial contamination. The vast majority of reads in mNGS are derived from human host. This would impede the overall analytical sensitivity of mNGS for pathogen detection. Host depletion methods or targeted sequencing may help to partially mitigate this disadvantage. As mNGS could not, by itself, define whether the detected microbe is the causative pathogen or environmental microorganism, a multidisciplinary discussion by clinicians, microbiologists as well as the lab technicians is required to interpret the result.

NCT ID: NCT05333133 Completed - Clinical trials for Infection, Bacterial

High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

High calorie formula (Oral Nutrition Supplement/ONS) are products used for oral nutrition support with the aim to increase the nutritional intake. they are a nutrition treatment option children with limited intake. ONS are typically used in addition to a normal diet, when diet alone is insufficient to meet daily nutritional requirement due to infection or others. ONS should be treated like medication, ensure they are labelled with the patient's name and provided at the prescribed time. It is well established that nutritional deficiency or inadequate can impair immune function. Growing evidence suggest that for certain conditions, the nutrient needs will be increased, so it is needed to provide the nutrient intake above currently recommended levels, in order to help optimizing the immune function, including improving the defense function and thus resistance to infection while maintaining tolerance. Purposes: 1. to analyze the effect of high calorie formula on IGF-1 levels in children with failure to thrive 2. to analyze the effect of high calorie formula on total lymphocyte counts with failure to thrive 3. to analyze the effect of high calorie formula on TNF-alpha levels in children with failure to thrive Hypothesis: 1. there is significant increment of IGF-1 levels before and after the intervention 2. there is significant difference of total lymphocyte counts before and after the intervention 3. there is significant difference of TNF-alpha levels before and after the intervention