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Enterobacteriaceae Infections clinical trials

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NCT ID: NCT05632315 Not yet recruiting - Clinical trials for Methicillin-resistant Staphylococcus Aureus

PMT for MDRO Decolonization

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, comparative Phase II trial being conducted to determine whether fecal microbiota transplant using Penn Microbiome Therapy (PMT) products helps standard therapy eradicate antibiotic-resistant bacteria.

NCT ID: NCT05611892 Recruiting - Clinical trials for Inflammatory Disease

Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS) in Diseased Patients

Start date: December 22, 2022
Phase:
Study type: Observational

This study is being performed to see if 18F-FDS is a useful imaging agent for diagnosis of bacterial infections. Position Emission Tomography (PET)/ computed tomography (CT) scans will be obtained after intravenous injection of 18F-FDS to determine biodistribution and pathophysiology in diseased subjects.

NCT ID: NCT05516433 Recruiting - Clinical trials for Enterobacteriaceae Infections

Effect of Imipenem and Meropenem on the Digestive Microbiota and the Emergence and Carriage of Multidrug-resistant Bacteria

MERIMI
Start date: January 23, 2023
Phase:
Study type: Observational

Among enterobacteria, ESBL production is the leading cause of multidrug resistance. The first cases of ESBL-producing Enterobacteriaceae (EBLSE) infections were described in the 1980s and subsequently spread worldwide. Since the turn of the century, the prevalence of EBLSE infections, particularly among E. coli and K. pneumoniae, has increased dramatically. The emergence of multidrug-resistant enteric bacteria (MRE) is currently a real public health problem. The European network for monitoring antibiotic resistance in cooperation with Santé Publique France evaluated the rate of resistance to third generation cephalosporins (C3G) among clinical strains at 10.2% for Escherichia coli and 28.8% for Klebsiella pneumoniae. The consequences of infections with multi-resistant enteric bacteria, mainly represented by ESBL, are currently well known, both from an individual point of view (increased mortality and length of hospitalization) and from a collective point of view (increased costs of care). The current reference treatment for ESBL-producing Enterobacteriaceae infections is based on carbapenems. Imipenem and meropenem are the two most commonly used carbapenems in clinical practice. Despite their similar spectrum of action, these two molecules have different pharmacokinetic properties, notably concerning their half-life and their elimination routes (mainly urinary for imipenem, mixed: biliary and urinary for meropenem). Some studies have suggested that imipenem has a low impact on the digestive microbiota. However, no studies comparing the impact of imipenem and meropenem have been conducted. Woerther et coll. explained in their work that the digestive microbiota confers resistance to colonization by MREs. The impact of antibiotics on the microbiota probably leads to a breakdown of this barrier and a loss of this resistance to colonization. Moreover, each antibiotic therapy does not impact the digestive microbiota in the same way and it seems that antibiotics with a high activity against strict anaerobic species and/or a high biliary elimination are the most impacting. It is therefore essential, in the era of multidrug resistance, to look at the influence of antibiotics on the digestive microbiota and on the emergence and carriage of MRE. In a context where the incidence of multi-resistant bacteria is constantly increasing, it seems relevant to conduct a study aiming at comparing the respective impact of the use of imipenem and meropenem on the emergence of MRE and on the digestive microbiota at the individual level. This study aims at comparing the microbiological impact (in terms of emergence of bacterial resistance and in terms of impact on the diversity of cultivable digestive bacteria). It will be a comparative study with matching of patients according to age, service and previous duration of hospitalization. Indeed, the usual management of patients with an infection requiring treatment with a carbapenem is different between the 2 participating centers. Thus, according to the usual management of patients in these 2 participating centers, patients at Avicenne Hospital are treated with meropenem and patients at the Paris Saint-Joseph Hospital Group with imipenem, except in the case of a need for a high daily dose (osteoarticular infection, for example) due to the neurological toxicity of imipenem at high dosage. In the case of high-dose use, meropenem will be the preferred molecule.

NCT ID: NCT05355350 Suspended - Bacteremia Clinical Trials

PipEracillin/Tazobactam Versus mERoPENem for Treatment of AmpC Producing Blood Stream Infections

SPICE-M
Start date: July 1, 2022
Phase: Phase 4
Study type: Interventional

Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacterales bloodstream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.

NCT ID: NCT05272410 Not yet recruiting - Clinical trials for Carbapenemase-producing Enterobacteriaceae Infections

Cost-effectiveness of Controlling CPE

OPTIM-BHRe
Start date: March 2022
Phase:
Study type: Observational

Spread of extensively drug-resistant bacteria (XDR) such as carbapenemase-producing Enterobacterales (CPE) is a major public health problem. Various prevention and control interventions are implemented to limit the transmission of XDR but they are expensive and often disrupt hospital organization. In this study, a mathematical model will be used to study the effectiveness and cost-effectiveness of control strategies to limit the spread of CPE in a general hospital ward. A case-control study will be conducted to estimate the excess length of stay and mortality attributable to CPE colonisation or infection.

NCT ID: NCT05258851 Terminated - Clinical trials for Carbapenem-Resistant Enterobacteriaceae Infection

Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections

AVI-ICU
Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

Carbapenem-Resistant Enterobacteriaceae (CRE) infections are a growing national and international challenge in healthcare settings. This is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with CRE reaching up to 50% as per the Centers of Disease Control and Prevention. Colistin-based combination regimens have been the mainstay for treating CRE-related infections. Ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against CRE along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. However, randomized clinical trials are lacking. This non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with CRE infections in comparison to colistin-based regimens.

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: NCT05055479 Completed - Clinical trials for Enterobacteriaceae Infections

Nosocomial Outbreak of BHRe in an Intensive Care Unit During SARS-CoV-2 Pandemic

BHReICU
Start date: August 1, 2021
Phase:
Study type: Observational

Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.

NCT ID: NCT05035342 Recruiting - Clinical trials for Fecal Microbiota Transplantation

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

FECES
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.

NCT ID: NCT04903886 Not yet recruiting - Bacteremia Clinical Trials

Intensive Care Unit Acquired Infections in Patients Colonized With Extended Spectrum Enterobacteriaceae

BMREA
Start date: June 1, 2021
Phase:
Study type: Observational

Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved. The investigators also collect data about antibiotherapy used to treat these infections.