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Pneumonia, Bacterial clinical trials

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NCT ID: NCT03711331 Recruiting - Clinical trials for Pneumonia, Bacterial

Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Patients With Hospital-acquired Pneumonia

VAPERO
Start date: June 16, 2020
Phase: N/A
Study type: Interventional

VAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.

NCT ID: NCT03583333 Completed - Clinical trials for Ventilator-Associated Bacterial Pneumonia

Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.

NCT ID: NCT03577964 Active, not recruiting - Clinical trials for Glucose Metabolism Disorders

Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

Start date: September 1, 2017
Phase:
Study type: Observational

Incidence of Pneumonia in Patients with high systemic glucose levels.

NCT ID: NCT03551210 Completed - Clinical trials for Pneumonia, Bacterial

Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia

Start date: May 4, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to evaluate the clinical efficacy of treatment with Nemonoxacin compared with Tavanic® in patients with community-acquired pneumonia (CAP).

NCT ID: NCT03506191 Active, not recruiting - Critical Illness Clinical Trials

Pneumonia Due to Stenotrophomonas Maltophilia in ICUs

RETROSTENO
Start date: January 1, 2017
Phase:
Study type: Observational

Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients. Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.

NCT ID: NCT03418272 Withdrawn - Clinical trials for Ventilator Associated Pneumonia

Cultures in PICU Patients Compared to Healthy Children

Start date: February 2023
Phase:
Study type: Observational

This study is being done to determine if the bacteria found in your mouth (oral flora bacteria) in children admitted to the intensive care unit who need to be on a breathing machine is different from the oral flora in healthy children undergoing anesthesia for their dental caries. Children in the intensive care unit with a breathing tube are at a higher risk for getting a lung infection due to the bacteria in the mouth slipping into their lungs past the breathing tube over several days. This means that bacteria are found in the child's lung when this is normally not the case. If the bacteria in the mouth have changed from normal then they may get a pneumonia.

NCT ID: NCT03382548 Completed - Clinical trials for Ventilator Associated Pneumonia

Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection

REGARD_VAP
Start date: February 21, 2018
Phase: Phase 3
Study type: Interventional

Intensive care units (ICUs), with high antibiotic consumption, are epicentres of antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest hospital-acquired infection (HAI) in ICUs and is associated with a high morbidity and mortality in these vulnerable patients despite antibiotic therapy. No well-designed clinical trials studying antibiotic duration for VAP caused by predominantly non-fermenting Gram-negative bacteria have been conducted to date. Shortening antibiotic duration has the potential to improve individual patient outcomes and indirectly benefit other patients by reducing the selection pressure for multidrug resistant (MDR) bacteria within the ICU. The study aims to demonstrate clinical non-inferiority-superiority of a short duration of antibiotics (up to 7 days) versus prolonged antibiotic therapy (as per physician preference) in adults with VAP in Asia. Patients who have been ventilated for more than 48 hours will be screened daily for signs and symptoms of VAP according to the US Centers for Disease Control and Prevention VAP criteria. Recruited patients will be reviewed daily for clinical signs of stability including temperature <38°C for 48 hours, systolic blood pressure >90mmHg without inotropes. Recruited patients will be randomised once they fulfill these clinical criteria of stability. In the intervention arm, antibiotics should be stopped within 7 days once the above criteria are fulfilled. In the control arm, antibiotics should be at least 7 days with the exact duration decided by the managing physicians. The primary outcome of the study is a combined endpoint of mortality and VAP recurrence at day 60 of recruitment. The study hypothesis is that a shorter duration of treatment for VAP (7 days or less depending on clinical response) is not only noninferior, but may also be superior to a longer duration (8 days or more). The secondary outcomes of the study include clinical parameters such as rate of acquisition of MDRO hospital-acquired infections, duration of ventilation and hospitalization and days of antibiotics use. The study team will also characterise the microbiome changes in study participants according to the type and duration of antibiotics. MDROs collected will undergo whole genome sequencing for transmission dynamics study. The study is a multinational multicenter study involving hospitals in Asia. Funder: The project will beis partly joinly funded by Medical Research Council/ Department for International Development (MRC/DfID) and Singapore National Medical Research Council (NMRC/CTG). Grant Ref: MR/K006924/1 and MOH-000470 (MOH-CTGIIT18may-0003) Conclusions This is a randomised controlled hierarchical non-inferiority-superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations. Publication of this study https://pubmed.ncbi.nlm.nih.gov/33986070/

NCT ID: NCT03379779 Completed - Respiratory Failure Clinical Trials

Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure

Start date: August 28, 2017
Phase:
Study type: Observational [Patient Registry]

A prospective observational study. Enrolled participants admitted to ICU due to pneumonia and respiratory failure need mechanical ventilator support. Investigators collected the residual specimens, such as sputum from endotrachea aspiration, bronchoalveolar lavage fluid in those participants as the usual care in the ICU. Those residual samples were sent to extract RNA and sequence by using high-throughput sequencing (next-generation sequencing) method. Investigators will compared the microbiome feature between lower respiratory tract and stool specimens in those participants diagnosed as pneumonia with respiratory failure.

NCT ID: NCT03367624 Recruiting - Influenza Clinical Trials

Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus

FLUVALENTINE
Start date: October 1, 2017
Phase: N/A
Study type: Observational

Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to affect young patients (20-40 years) without any medical history. Since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. However, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies. The main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus

NCT ID: NCT03303976 Completed - Clinical trials for Pneumonia, Bacterial

Phase I to Test a New Pneumococcal Vaccine

Start date: September 7, 2017
Phase: Phase 1
Study type: Interventional

To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in healthy adult and elderly volunteers. The study aims to assess the safety and immunogenicity of a bioconjugate investigational vaccine compared to the control group (Pneumovax23).