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Pneumonia clinical trials

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NCT ID: NCT04223752 Recruiting - Clinical trials for Nosocomial Pneumonia

Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

Start date: April 17, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).

NCT ID: NCT04215991 Recruiting - Clinical trials for Gram-negative Bacterial Infections

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).

NCT ID: NCT04208945 Recruiting - Clinical trials for Pneumonia, Ventilator-associated

Nebulized Colistin for Gram Negative VAP Prevention.

VAPICO
Start date: December 2019
Phase: N/A
Study type: Interventional

Colistin is used as an elective treatment of infections of multi drug resistant gram negative bacteria. Until now colistin is used in the therapeutic regimen of these infections intravenous or nebulized. There are a plenty of studies about the efficacy of nebulized colistin in the therapy of pseudomonas aeruginosa pneumonia in patients with cystic fibrosis and in the therapy of ventilator associated pneumonia in ICU. On the other hand there are only a few studies about the use of nebulized colistin in the prevention of ventilator associated pneumonia whereas the role of nebulized colistin in the prevention of severe forms of pneumonia such as VAP due to multi drug resistant gram negative bacteria are limited. This double blinded randomized trial aim to investigate the effect of nebulized colistin on the incidence of patients with due to gram negative bacteria in the ICU compared to nebulized normal saline.

NCT ID: NCT04200742 Recruiting - Pneumonia Clinical Trials

Standardized BAL Procedure for Critical Patients to Diagnose Pneumonia Pathogens

STABAL
Start date: September 16, 2019
Phase:
Study type: Observational

In order to improve the accuracy of the diagnosis of pulmonary pathogens and reduce the adverse impact of excessive BAL volume on patients, this study intends to explore the most optimal lavage volume in the middle lobe and the lower lobe of critical patients as well as seeking for the best way to manage BALF samples by means of detecting alveolar proteins and bacterial composition in BALF samples. The hypothesis is that the optimal lavage volume in the middle lobe and the lower lobe might be different. And to sample BALF separately through sequential lavage might be a better way to improve the accuracy of the diagnosis of pneumonia pathogens.

NCT ID: NCT04199962 Recruiting - Sepsis Clinical Trials

Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis

Start date: December 12, 2019
Phase:
Study type: Observational

This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

NCT ID: NCT04193878 Recruiting - Pneumonia Clinical Trials

ARrest RESpiraTory Failure From PNEUMONIA

ARREST
Start date: June 1, 2020
Phase: Phase 3
Study type: Interventional

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

NCT ID: NCT04178382 Recruiting - Severe Sepsis Clinical Trials

Effect of PCR-CRISPR/Cas12a on the Early Anti-infective Schemes in Patients With Open Air Pneumonia

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study is a multicenter randomized controlled trial. The purpose of this study is to assess the efficacy of the combination of PCR and CRISPR/Cas12a in alveolar lavage fluid for early targeted anti-infective therapy for patients with severe pneumonia. Hosted by the Department of Critical Care Medicine, Affiliated Drum Tower Hospital of Nanjing University Medical College, 5 adult ICU units participate in 3 hospitals. All patients are randomly assigned to the experimental group and the control group. For experimental group, the combined detection of PCR and CRISPR/Cas12a in the alveolar lavage fluid was carried out in the early stage, and the antibiotic scheme is changed base on the results of PCR-CRISPR/Cas12a.The patients in the control group were adjusted according to the traditional microbial detection methods. The types of early antibiotics, the proportion of target antibiotics, the duration of anti-infective treatment, the length of hospital stay in ICU, the mortality rate, the secondary antibiotic-associated diarrhea, and the incidence of new multidrug-resistant infections were recorded.

NCT ID: NCT04165356 Recruiting - Clinical trials for Pneumonia Associated With Mechanical Ventilation

Efficacy of Mouth-rinse With Chlorhexidine for the Prevention of Ventilator-associated Infections in Intensive Care Unit

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

Background: Infections associated with mechanical ventilation are associated with high rates of morbidity and mortality, which results not only in an increase in hospitalization days and care costs, but also in an increase in DALYS (years of life disability adjustment) in the population. Critically ill patients have a high risk of infection as a result of underlying immunodeficiency, comorbidity and placement of invasive devices (such as endotracheal tubes and intravascular devices). Infections in these patients constitute a challenge for hospital authorities, as they are considered a social and economic problem that influences the quality of care, in a system where health services are increasingly affected by high patient care costs and the reduction of public spending. The decrease in the number of bacteria in the oral cavity reduces the presence of microorganisms available for translocation and colonization of the lower respiratory tract; Therefore, performing oral care intervention is considered an economically attractive method to reduce the risk of developing infections associated with endotracheal intubation. In our environment, oral cleaning is performed as part of the nursing care package granted to all patients of the ICU, however, there is no standardized method among nursing staff that guarantees the desired prevention. Objective: To evaluate the efficacy and safety of mouth-rinse with 0.12% chlorhexidine to prevent infections associated with mechanical ventilation in patients in the intensive care unit in a third level hospital in Mérida, Yucatán. Hypothesis: Mouth-rinse with 0.12% chlorhexidine twice daily more effective and safe than mouthwash with bicarbonated isotonic solution twice daily to prevent infections associated with mechanical ventilation in patients in the intensive care unit of a hospital third level. Methodology: Double-blind randomized controlled clinical trial with active substance for the evaluation of the non-inferiority of the efficacy and safety of mouthwash with 0.12% chlorhexidine twice daily compared to isotonic bicarbonated solution twice daily for the prevention of any infection associated with mechanical ventilation in patients requiring endotracheal intubation in the intensive care unit of a third level hospital.

NCT ID: NCT04157998 Recruiting - Clinical trials for Aspiration Pneumonia

Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

the risk of aspiration pneumonitis during cesarean sections has significantly decreased. Nevertheless, precaution against gastric aspiration is still vital in patients in whom regional anesthesia contraindicated or in whom general anesthesia has to be administered (for example; during emergency cesarean delivery). The administration of intravenous anesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anesthesia

NCT ID: NCT04153682 Recruiting - Clinical trials for Hospital-acquired Pneumonia

Trial on a Strategy Combining Rapid Diagnostic Testing and Antimicrobial Stewardship to Improve Antibiotic Use in Patients With Hospital-acquired Pneumonia.

SHARP
Start date: February 21, 2020
Phase: N/A
Study type: Interventional

Hospital-Acquired Pneumonia (HAP) is the second most frequent hospital-acquired infection in the US and Europe and accounts for a large proportion of antibiotics prescribed in hospitals. Conventional methods to identify causative microorganisms (virus, bacteria) are time-consuming and sometimes inaccurate, leading to inadequate treatment in a large proportion of HAP patients. The FILMARRAY® Pneumonia Panel (FA-PP, bioMérieux) is an automated diagnostic device, allowing detection of multiple pathogens and resistance markers in one hour. Strategies combining rapid diagnostic testing and intervention of specialists in infectious diseases (i.e. antimicrobial stewardship -AMS - experts) showed significant synergistic impact on antibiotic use, mortality and costs in bloodstream infections. The trial hypothesis is that a strategy combining antimicrobial stewardship and FA-PP improves quality of care in HAP patients, as compared to antimicrobial stewardship alone. The trial will include patients hospitalized for ≥ 48 hours, aged 18 years or older, who have criteria of pneumonia: new lung infiltrate on a chest-x ray, plus evidence that the infiltrate is of an infectious origin (i.e. new onset of fever and/or purulent sputum and/or leukocytosis and/or decline in oxygenation). After informed consent, participants will be randomly allocated to either the intervention or the control arm. In the control arm, management of HAP patients will include clinical examination and conventional microbiological tests. Antibiotic choice will be discussed between AMS experts and the physician in charge of the patient. In the intervention arm, in addition to the procedures above, the strategy will include rapid testing using the FA-PP on a respiratory specimen, obtained by either invasive or non-invasive sampling. No additional invasive procedures will be required for the study, and FA-PP will be performed on samples collected as part as routine care. Investigators will visit the patient at inclusion, on day 3 and on day 30 (or at hospital discharge) to collect data on comorbidities, clinical outcomes, results of microbiological tests and antibiotics. At the end of follow-up, we will compare the number of days on broad-spectrum antibiotics, the incidence of negative outcomes, the length of stay and costs in the two arms. The use of the FA-PP is expected to prompt early adjustment of antibiotic therapy, improve outcomes, decrease length of stay, and to reduce the use of broad-spectrum antibiotics. The antibiotic saving may reduce the selection pressure, incidence of colonization with multidrug-resistant bacteria and incidence of hospital-acquired superinfections, both at an individual and hospital level. Moreover, this trial relies on the intervention of multidisciplinary AMS teams that are currently being implemented in many health facilities. Their transversal position offers opportunities for recruitment of patients from a wide range of medical and surgical departments. This project evaluates the feasibility of clinical trials based on the intervention of these teams, and will provide a high level of evidence regarding their impact on the prognosis of patients, appropriate use of antibiotics, and antimicrobial resistance.