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Bacterial Infections clinical trials

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NCT ID: NCT03919032 Completed - Cirrhosis Clinical Trials

Bacterial Infections in Patients With Cirrhosis in Argentina: Clinical and Microbiological Characteristics

Start date: October 16, 2018
Phase:
Study type: Observational

In recent years, there has been an increasing prevalence of bacterial infections caused by multiresistant and extremely resistant organisms in patients with cirrhosis. These infections are associated with a worse prognosis, generate difficulties in the management of the patient during hospitalization and increase health costs. The main objective of this project is to estimate the prevalence of infections by multiresistant bacteria in patients with cirrhosis. Additionally, the prevalence of other antibiotic resistance patterns and morbi-mortality in the study population will be evaluated. For these purposes, a multicenter prospective cohort study will be carried out, including patients with cirrhosis who present bacterial infections at the time of admission, or during hospitalization. Performing a study in Argentina on the clinical and microbiological characteristics of bacterial infections in patients with cirrhosis could be very useful to develop new strategies for prevention and treatment of this severe complication.

NCT ID: NCT03915275 Not yet recruiting - Clinical trials for Bacterial Infections

Clinical Impact of 16S rDNA PCR

CI16DP
Start date: May 1, 2019
Phase:
Study type: Observational

The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management. The secondary objectives of the protocol are: - to evaluate bacterial identification performance - to evaluate the effect of previous antibiotic therapy - to analyze the management of discordant results between 16S PCR and culture identification

NCT ID: NCT03910673 Completed - Bacterial Infection Clinical Trials

Intravenous Fosfomycin Pharmacokinetics Study

Start date: June 27, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling timepoint, with blood sampling volume that is adequate for testing. The objectives of the study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of IV-infused ZTI-01.

NCT ID: NCT03903783 Completed - Clinical trials for Infection, Bacterial

Impact of Cefotaxime and Ceftriaxone on the Emergence and Carrying of Multidrug-Resistant Bacteria

CROCTX
Start date: April 30, 2019
Phase: N/A
Study type: Interventional

Among enterobacteria, the production of ESBL is the first cause of multidrug resistance. The first cases of ESBL-producing enterobacteriaceae (EBLSE) infections were described during the 1980s and subsequently experienced global spread. Since the beginning of the century, the prevalence of EBLSE infections, especially among E. coli and K. pneumoniae, has increased dramatically. The emergence of multidrug-resistant enterobacteria is currently posing a real public health problem. The European antimicrobial resistance surveillance network evaluated, among clinical strains, the resistance rate for 3rd generation cephalosporins (C3G) at 9.5% for Escherichia coli and 28% for Klebsiella pneumoniae. The consequences of multidrug-resistant enterobacterial infections, which are mainly represented by ESBLs, are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase of costs of care). Data from the literature reveal an increased risk of ESBL bacteremia in patients with rectal carriage of ESBL-producing enterobacteria. The study by Goulenok et al. found as a risk factor for EBLSE bacteremia in patients known to be carriers at the rectal level the existence of antibiotic selection pressure and the presence of a urinary catheter. Woerther et al. have explained in their work that the digestive microbiota confers resistance to colonization by BMR. The impact of antibiotics on the latter leads to a probable rupture of this barrier and a loss of this resistance to colonization. In addition, each antibiotherapy does not impact the digestive microbiota equally and it seems that antibiotics with high anti-anaerobic activity or high biliary elimination are the most impacting. It is therefore essential, at a time of multidrug resistance, to focus on the influence of antibiotics on the digestive microbiota and the emergence and carriage of BMR. Ceftriaxone and cefotaxime are two injectable injectable third-generation cephalosporins (C3G) commonly used in clinical practice. Despite their similar spectrum of action, it should be noted that they have substantially different pharmacokinetic properties, especially with regard to their half-life and their elimination routes (mainly urinary for cefotaxime, mixed: biliary and urinary for ceftriaxone). Some works have already been interested in this topic. Grohs et al. carried out a comparative study between ceftriaxone and cefotaxime on the emergence of AmpC hyperproducing enterobacteria (HL-CASE). This single-site study demonstrated that, at a hospital level, the preferential use of cefotaxime rather than ceftriaxone had collective and ecological benefits at the service level. Indeed, their results conclude that resistance development is weaker, as well as more limited carriage of HL-CASE Enterobacterial strains by replacing ceftriaxone with cefotaxime. It should be noted, however, that the modification of prescribing practices of C3G has been coupled with various measures to limit the emergence of AmpC hyperproductive enterobacteria (reinforcement of hygiene rules, awareness of the health care team at EBLSE, control of antibiotic ...). In a context where the emergence of multidrug-resistant bacteria continues to increase, it seems appropriate to conduct a study to compare the impact of the use of ceftriaxone or cefotaxime on the emergence of BMR at the individual level. In the absence of a study clearly establishing the link between C3G types (ceftriaxone, cefotaxime) and the emergence of BMR and in line with the above research, this study aims to compare the microbiological impact of the use of either of these two C3Gs (in terms of emergence of bacterial resistance and impact on the diversity and quantity of digestive digestive bacteria). The study will have two periods: Period 1 during which patients hospitalized in the emergency department or in internal medicine and receiving C3G antibiotics will receive ceftriaxone, and the period 2 during which cefotaxime is cephalosporin used in first intention in these same patients. Thus, this research project, by focusing on these 5 parameters in patients treated with ceftriaxone or cefotaxime, should make it possible to prove the influence of these antibiotherapies on the carriage of BMR (deleterious action on the diversity and the quantity of the intestinal bacterial flora, resulting in an increase in the relative fecal abundance of these BMRs promoting their carriage). In addition, the hypothesis is that, contrary to current data, cefotaxime is found at sufficiently high concentrations in the feces to have an impact on the microbiota equivalent to that of ceftriaxone, despite less significant biliary elimination. This study therefore aims to compare their impacts on the microbiota and in particular on the emergence of multidrug-resistant bacteria (BMR) and enteropathogens such as Clostridium difficile.

NCT ID: NCT03896685 Active, not recruiting - Tuberculosis Clinical Trials

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

endTB-Q
Start date: April 6, 2020
Phase: Phase 3
Study type: Interventional

endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB) with fluoroquinolone resistance.

NCT ID: NCT03883230 Completed - Diabetic Foot Clinical Trials

Wound Infection Detection Evaluation, WIDE

WIDE
Start date: July 27, 2017
Phase:
Study type: Observational

Chronic wounds, such as diabetic foot ulcers, place a huge burden on healthcare systems and can lead to complications with high morbidity, particularly if the wound if infected. In parallel, there is pressure to reduce the use of antibiotics in order to minimise the risk of antimicrobial resistance. The Glycologic wound detection kit (GLYWD) is a point-of-care test, designed to provide guidance to clinical staff as to whether a chronic wound is infected or not. In this prospective cohort study the premise of this mode-of-action is evaluated. GLYWD will be applied in conjunction with clinical opinion and microbiological testing to determine if there is concordance between the different diagnostic approaches, and if applicable how they may differ in certain patients' wounds.

NCT ID: NCT03858387 Recruiting - Critical Illness Clinical Trials

PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients

Start date: September 1, 2018
Phase:
Study type: Observational

Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.

NCT ID: NCT03857295 Not yet recruiting - Clinical trials for Bacterial Infections

Infections Following NeuroSurgery (INS)

INS
Start date: March 11, 2019
Phase:
Study type: Observational

Neurosurgery (NS) is essential for the treatment of various diseases such as malignant tumors, vascular conditions, spinal stenosis or trauma. However, NS can be complicated by the onset of infections, directly related to surgery or to hospitalization. Little is known regarding the epidemiology, the optimal treatment regimens and the outcome of infections following NS (I-NS). The study aims at investigating the clinical and microbiological characteristics as well as the outcomes of I-NS occurring at a single Institution (IRCCS Neuromed, Pozzilli, Italy) during the period 2016-2018. Patients with at least 1 infective episode requiring antimicrobial therapy are included in this retrospective observational study.

NCT ID: NCT03855709 Not yet recruiting - Clinical trials for Antibiotic Resistant Infection

Antibiotic-resistant Bacterial Infection of Hepatic Patients

Start date: May 2019
Phase:
Study type: Observational

the investigators want to identify the microbial profile, antibiotic resistant bacteria in hepatic patients with infections in Liver ICU, and explore risk factors and outcomes in those patients with antibiotic resistant bacteria.

NCT ID: NCT03846921 Recruiting - Clinical trials for Bacterial Infections

Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections

Start date: March 4, 2019
Phase:
Study type: Observational

This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.