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Bacterial Infections clinical trials

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NCT ID: NCT05942820 Terminated - Clinical trials for Bacterial Infections

The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers

Start date: August 30, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.

NCT ID: NCT05210387 Terminated - Sepsis Clinical Trials

Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections

OPTIMISE
Start date: January 27, 2022
Phase: N/A
Study type: Interventional

Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the most common pathogens associated with multidrug resistance and HAIs. These bacteria are of special concern because few therapeutic options are available. Traditionally, the duration of treatment for severe multidrug-resistant (MDR)-GNB infections is 14 days. Studies of severe infections by GNB, regardless of susceptibility profile, have shown that shorter antimicrobial treatments are not inferior to traditional durations of therapy and are associated with a lower incidence of adverse effects. However, there are currently no studies assessing whether shorter duration of antimicrobial treatment is effective for MDR-GNB. This open-label, randomized clinical trial aims to assess the non-inferiority of 7-day antibiotic therapy compared to conventional 14-day treatment in severe infections by MDR-GNB.

NCT ID: NCT05095623 Terminated - Clinical trials for Recurrent Bacterial Infection, Autoimmune Disorder

A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease

Start date: August 31, 2021
Phase:
Study type: Observational

This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.

NCT ID: NCT04847921 Terminated - Clinical trials for Substance Use Disorders

Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition

SUDDEN-OUT
Start date: April 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The Investigators hypothesize, that a simplified 2-dose dalbavancin regimen, will improve compliance with antimicrobial therapy and that it may facilitate engagement in the treatment of the underlying substance use disorder, and particularly injection drug use - often the true etiology behind these severe infections.

NCT ID: NCT04783727 Terminated - Clinical trials for Bacterial Infections

PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic signature-based model compared to the standardised twenty months treatment in a cohort of multidrug-resistant tuberculosis patients.

NCT ID: NCT04287478 Terminated - Clinical trials for Urinary Tract Infection Bacterial

Bacteriophage Therapy in Patients With Urinary Tract Infections

Start date: December 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

NCT ID: NCT04126031 Terminated - Clinical trials for Gram-negative Bacterial Infection

Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

NOOR
Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.

NCT ID: NCT04076345 Terminated - Fever Clinical Trials

Interest of the Presepsin Assay as a Biomarker of Bacterial Infection, in the Management of Newborns and Infants Under 3 Months of Age Admitted for Fever in Pediatric Emergency Service (Presepsin)

presepsin
Start date: July 29, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT03696901 Terminated - Clinical trials for Bacterial Infections

Xydalba Utilization Registry in Germany

Start date: November 21, 2018
Phase:
Study type: Observational

This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in Germany. Such observational studies are also referred to as registries. The sponsor of the study is Correvio International Sárl, based in Switzerland. Xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called "gram positive bacteria") which cause the disease. Active ingredients against bacteria are also called antibiotics. Correvio wants to know which patients received the drug and how the disease went. The treatment places where you got Xydalba, ie clinic, intensive care unit or elsewhere should be recorded. In addition, it is important in this type of medication to track whether the pathogens are changing in any way. Any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent European authorities.

NCT ID: NCT03633188 Terminated - Clinical trials for Infection, Bacterial

Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection

GUMIBONE
Start date: July 19, 2018
Phase: N/A
Study type: Interventional

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.