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Bacterial Infections clinical trials

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NCT ID: NCT03230916 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

Start date: November 6, 2017
Phase: Phase 1
Study type: Interventional

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.

NCT ID: NCT03225079 Terminated - Clinical trials for Severe Bacterial Infection

PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

PERFORM
Start date: November 8, 2017
Phase:
Study type: Observational [Patient Registry]

International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial

NCT ID: NCT03204591 Recruiting - Clinical trials for Bacterial Infections

Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

Start date: July 20, 2017
Phase:
Study type: Observational

Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.

NCT ID: NCT03192072 Completed - Clinical trials for Bacterial Infections

A Rapid Test for Acute Respiratory Illness

Radical
Start date: July 17, 2017
Phase:
Study type: Observational

The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard. Secondary objectives include: 1. Evaluate the effect of age on the performance of the HR-ARI test 2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test 3. Evaluate the effect of geography on the performance of the HR-ARI test

NCT ID: NCT03182504 Completed - Clinical trials for Gram-negative Bacterial Infections

A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants

Start date: June 15, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. Adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.

NCT ID: NCT03172039 Completed - Clinical trials for Infection, Bacterial

Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit

Start date: May 12, 2017
Phase: N/A
Study type: Observational

This quality improvement study will assess the antimicrobial use and prescribing practices of hospital and community prescribers for the ambulatory hemodialysis (HD) population in an urban academic outpatient HD unit in Ontario. Currently, in the outpatient HD unit at Toronto General Hospital (TGH), it is the standard of care for the patients to be screened on a weekly basis by the nephrology care team for the use of any oral or intravenous antimicrobials. Patient charts, pharmacy patient profiles and electronic medical records for these patients from September 1 2016 - April 30 2017 will be retrospectively reviewed in order to characterize antimicrobial use and its concordance with available clinical guidelines and antimicrobial stewardship principles described by the Centers for Disease Control and Prevention (CDC). The primary objective of the study is to determine the prevalence of antimicrobial use in an ambulatory HD population. The secondary objective of the study is to determine the congruence of prescribed antimicrobial regimens with available clinical guidelines and antimicrobial stewardship principles described by the CDC. It is hypothesized that antimicrobial use among HD patients will be common and that antimicrobial prescribing practices are not congruent with recommendations from published clinical guidelines and antimicrobial stewardship principles for a significant proportion of patients included in the retrospective review. Descriptive analysis of the data will summarize the findings. Future research will build upon the results of this project, and may include the development of interventions that target gaps in knowledge and prescribing behaviours of prescribers who provide care to the ambulatory HD population.

NCT ID: NCT03163628 Completed - Clinical trials for Infection, Bacterial

biomArkers to differeNtiate bacTerial From vIral iNfEctions

ANTOINE
Start date: June 6, 2017
Phase: N/A
Study type: Interventional

ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36 months. Fever is a frequent cause of consultation in pediatric emergency departments. Clinical diagnostic tools are rare and discrimination between severe bacterial infection and viral infection is difficult to confidently state. The prevalence of severe bacterial infections (IBS) varies from 10 to 25% according to the studies. Biological markers such as procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice. These markers have bacterial specificity but share a wide range of values with viral infections and do not make it possible to exclude or to confirm definitively the diagnosis of IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is increasingly studied in adults. The diagnostic value of these new markers has been demonstrated by associating their dosage with that of CRP for example. This is the case for IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination of biomarkers to discriminate against viral and bacterial infections could be a major help in the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of 800 patients.

NCT ID: NCT03160040 Completed - Clinical trials for Gram-Negative Bacterial Infections

A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting

Start date: October 11, 2017
Phase:
Study type: Observational

This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.

NCT ID: NCT03159403 Completed - Clinical trials for Gram-Positive Bacterial Infections

A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting

Start date: April 12, 2017
Phase: N/A
Study type: Observational

This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.

NCT ID: NCT03150082 Completed - Clinical trials for Infections, Bacterial

Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects

Start date: August 1, 2017
Phase: Phase 1
Study type: Interventional

This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at least 7 days and not more than 14 days. The total duration of study for each subject will be approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a single center.