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Klebsiella Infections clinical trials

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NCT ID: NCT06190548 Completed - Clinical trials for Infection, Bacterial

Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

HVCRKP
Start date: July 1, 2019
Phase:
Study type: Observational

The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.

NCT ID: NCT05862402 Recruiting - Clinical trials for Carbapenem Resistant Klebsiella Pneumoniae

Dose Optimization by Pharmacokinetic/Pharmacodynamic of Antibiotics to Improve Clinical Outcome of Carbapenem Resistant Klebsiella Pneumoniae Bloodstream Infections in Critically Ill Patients at Phramongkutklao Hospital

Start date: May 7, 2023
Phase: Phase 4
Study type: Interventional

The patients who infected with Carbapenem resistant Klebsiella pneumoniae were high mortality rate. Appropriate antibiotics therapy adjusted by Pharmacokinetic/Pharmacodynamic plays an important role in determining outcomes in Critically ill patients. Consequently, standard antibiotics dose may not be adequate to achieve pharmacokinetic/pharmacodynamic target in Critically ill patients. The purpose of this study is to compare the clinical outcomes between the critically ill patients who received antibiotics dose adjusted by pharmacokinetic/pharmacodynamic using Monte Carlo simulation and historical critically ill patients who received antibiotics from standard practice.

NCT ID: NCT05516654 Recruiting - Clinical trials for Detection of Type VI Secretion System in K.Pneumoniae

Type VI Secretion System in Klebsiella Pneumoniae

Klebsiella
Start date: September 10, 2022
Phase:
Study type: Observational

Klebsiella pneumoniae (K. pneumoniae) is an important opportunistic pathogen contributing to nosocomial and antimicrobial-resistant infections. The increasing prevalence of infections caused by multidrug-resistant K. pneumoniae has emerged as a major clinical and public health threat, while the serous organ and life-threatening infections caused by highly virulent K. pneumoniae have also emerged( Russo and Marr, 2019; Wyres et al., 2020).

NCT ID: NCT05193045 Active, not recruiting - Clinical trials for Klebsiella Infections

Prognosis of Klebsiella ESBL Sepsis: Role of 2-HYDRoxy-myristate in Endotoxin Structure

PoKES2_HYDRES
Start date: October 28, 2021
Phase:
Study type: Observational

Infections constitute a multiple and heterogeneous set of pathologies, and the first cause of mortality worldwide. Among them, sepsis is a more recent nosological entity, including the most severe forms of acute infectious pathologies, its frequency increasing considerably over time. It is considered to be the cause of more than 27 million deaths per year, more than 4,000 deaths per day in the United States and about 200 deaths per day in intensive care units in France. The occurrence of hemodynamic failure within visceral damage is a poor prognostic factor, the lethality in this situation can reach 60% of affected patients. The amount of organ dysfunction is also prognostic. More worryingly, the initial mortality is aggravated by the persistence of the negative evolution after hospital treatment, the 5-year prognosis being significantly more severe in the population of patients treated for sepsis than in the general population, particularly in the case of respiratory or cardiovascular damage during the stay in intensive care. The most frequent causes of these severe infections in the ICU are lower respiratory infections, particularly pneumonia acquired under mechanical ventilation, urinary tract infections and digestive tract infections. Sepsis corresponds to an infection of particular severity, which results in the association of organ failures, the type and severity of which vary according to the patient, the origin of the infection and the pathogen responsible. The severity of the picture will require specific management and may necessitate the introduction of organ supplements or even lead to death in the most serious forms. Infections by enterobacteria and in particular Klebsiella spp. are frequent in the intensive care unit. The association with antibiotic resistance and especially with ESBL production is a daily clinical situation. During these infections, the prognosis is variable, sometimes very poor, without it being possible to determine whether this evolution is due to antibiotic resistance or to the virulence of the pathogen. The objective of this work is to study the structure of lipid A of ESBL-producing Klebsiella strains responsible for nosocomial infections. This study is part of the "EVENT" protocols of which it is an ancillary analysis. The objective of this study is to evaluate the role of the presence of 2-hydroxymyristate within lipid A of the lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU. The secondary objectives correspond to the evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system), and the presence of 2-hydroxymyristate and the risk of bacteremia.

NCT ID: NCT04959344 Completed - Clinical trials for Klebsiella Pneumoniae Infection

Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V)

Start date: July 5, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

In this study, the tetravalent bioconjugate candidate vaccine Kleb4V will be tested to obtain first-time-in-human (FTIH) data on its safety and immunogenicity in healthy adults.

NCT ID: NCT04760665 Recruiting - Clinical trials for Carbapenemase-producing Enterobacteriaceae Infection

Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae

KAPEDIS
Start date: October 4, 2021
Phase: Phase 2
Study type: Interventional

Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial. The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction. Secondary objectives are: - To evaluate the safety of FMT. - To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT. - To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention. - To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention. - To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.

NCT ID: NCT04489459 Recruiting - Clinical trials for Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae

Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae

Start date: September 21, 2019
Phase: Phase 4
Study type: Interventional

This prospective, comparative study is evaluating the effectiveness and adverse effects of using colistin at a loading dose of 9 million international units (MIU) followed by 4.5 MIU every 12 h (q12 h) + tigecycline at a loading dose of 100 mg followed by 50 mg every 12 h (q12 h) versus colistin + meropenem 2 g q8 h in treating blood stream infections due to multidrug-resistant (MDR) Klebsiella pneumoniae. The aims of the current study are to investigate and evaluate the therapeutic activity and side effects of Colistin-Meropenem combined therapy versus Colistin-Tigecycline combined therapy in treatment of patients with Multiple Drug Resistant (MDR)-Klebsiella pneumonia bacteraemia The primary goal is comparing 14 day mortality between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection as evaluation of the therapeutic activity of colistin - tigecycline vs. colistin - meropenem combined therapies. The secondary goal is comparing the comorbidities (nephrotoxicity, hepatotoxicity, neurotoxicity, hematological changes) between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection who will be treated with colistin - tigecycline versus colistin - meropenem combined therapies. Method: A total of 60 patients were divided into two groups (30 patients each); the first group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h plus Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12 and the second group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h plus Intravenous meropenem 2 g IV infusion over 30 minutes q8 h

NCT ID: NCT04413305 Recruiting - Clinical trials for Klebsiella Pneumoniae Infection

WGS-guided Tracking and Infection Control Measures of CRKP

Start date: May 28, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the effect of the infection control measures based on the active screening of carbapenem-resistant Klebsiella pneumoniae and whole-genome based tracking and surveillance though the hospital.

NCT ID: NCT04337840 Not yet recruiting - Clinical trials for Klebsiella Pneumoniae Sepsis

Analysis on the Infection Risk, Prognosis, and Drug Sensitivity of Klebsiella Pneumoniae.

Start date: May 5, 2020
Phase:
Study type: Observational

Nosocomial infections are increasing rapidly both internationally and domestically, especially carbapenem-resistant Klebsiella pneumoniae infections. However, there were still lack of evidence about the risk and prognosis in Taiwan. The choice of drug and related sensitivity test was also limited. We would analyze the infection risk, prognosis, and drug sensitivity of Klebsiella pneumoniae and focus on strategy to manage carbapenem-resistant Klebsiella pneumoniae infections.

NCT ID: NCT04229498 Not yet recruiting - Clinical trials for Bloodstream Infection

Comparison of Bloodstream Infections With Carbapenem Hetero-resistant vs Carbapenem Resistant Klebsiella Pneumoniae

COMBAT
Start date: April 2020
Phase:
Study type: Observational

COMBAT trial was contemplated to elucidate unknown clinical relevance of carbapenem heteroresistance among Klebsiella pneumoniae species. Bloodstream infections, type of frequently seen invasive infections that pathogen isolation, identification of antimicrobial resistance mechanisms can be performed efficiently, with carbapenem resistant Klebsiella pneumoniae (CRKp) and carbapenem hetero-resistant Klebsiella pneumoniae will be compared in terms of relevant clinical outcomes such as 30-day mortality rate, 14-day clinical cure rate, 7-day microbiological eradication rate and 90-day relapse/re-infection rate. In addition, underlying molecular resistance mechanisms causing carbapenem hetero-resistance among Klebsiella pneumoniae isolates will be investigated by using whole genome sequences.