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NCT07322549
Severe community-acquired pneumonia (CAP) and community-acquired aspiration pneumonia (CAAP) are common reasons for adult emergency department visits and subsequent admission to the intensive care unit (ICU). Three bacteria are primarily implicated in this type of pneumonia: Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus. Empirical antibiotic therapy for this condition is currently based on the use of beta-lactams. While third-generation cephalosporins (3GC) remain the beta-lactam of choice in French guidelines for CAP, the combination of Amoxicillin/Clavulanic Acid (AMC) at high-dose (\>3g/day) could represent an alternative. AMC is already recommended for severe CAAP and for non-severe CAP in France, and for severe CAP in the UK and the United States. Furthermore, good practice guidelines encourage the use of empirical antibiotic therapies that are then subsequently tailored to the narrowest-spectrum agents based on antibiograms. This approach aims to limit the emergence of multidrug-resistant bacteria and reduce the risk of Clostridioides difficile colitis, which can increase patient morbidity and mortality. This study aims to evaluate the susceptibility to AMC and 3GC, and to describe the empirical antibiotic therapies used and their subsequent adjustments, in adult patients admitted to the ICU for severe CAP and CAAP documented with Streptococcus pneumoniae, and/or Haemophilus influenzae, and/or Staphylococcus aureus.
NCT07475429
1. Sample: Clinical specimens (blood, urine, sputum, wound swabs) will be collected aseptically and transported to the microbiology laboratory for analysis. 2. Culture: Specimens will be inoculated on MacConkey agar and incubated at 35-37°C for 18-24 hours. Colonies with typical K. pneumoniae morphology (mucoid, lactose-fermenting) will be selected for further testing 3. Identification of isolates will be done by: Colony morphology, Gram staining, and conventional biochemical tests (eg, indole, citrate utilization, urease, Voges-Proskauer) . 4. Antimicrobial susceptibility testing of the isolates : Antimicrobial susceptibility testing was performed and interpreted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines, M100 document (latest edition)." 5. MIC determination for cifederecol using E-test . 6. Phenotypic Detection of hvKP: 1. String Test: A viscous string ≥5 mm formed by stretching a single colony indicates hypermucoviscosity . 2. Capsule Staining: to visualize large capsules . 3. Siderophore Production: Assessed on chrome azurol S (CAS) agar to detect iron-chelating activity. 7. Detection of siderophore genes by Simple qualitative PCR .
NCT07409727
Background Mechanical ventilation is an essential medical intervention in the context of critical illness. However, the intervention is associated with a risk of significant, potentially preventable complications. Among these are ventilator-associated pneumonia, sepsis, acute respiratory distress syndrome, atelectasis, and pulmonary edema. Ventilator-associated complications commonly increase morbidity and mortality. They may also prolong the duration of mechanical ventilation and the length of stay in the hospital or the intensive care unit, with increased health care costs; so safe, effective therapeutic and preventative strategies are essential to attenuate poor outcomes from ventilator-associated events. Secretion retention and ineffective cough play a significant role in failed extubation and weaning from ventilator; the presence of the artificial airway, poor humidification of inspired gases, and immobility are the major causes of pulmonary secretion retention in this population. Accumulated secretion in the airways, if extensive, starts a self-sustaining cycle of ventilation/perfusion mismatch, gas-exchange impairment, increased work of breathing. For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF); but its effects are not known if given by nebulization through endotracheal tube (ETT), studies to date have provided inconclusive results. Despite this uncertainty, mucoactive agents are still used in adult ICUs. NAC is usually administered orally, with several formulations and dosage forms available for both short- and long-term treatment of respiratory diseases. The inhalation route might also be considered a practical option, with recent interest, as the therapeutic drug acts directly on the bronchial mucosa, promotes continuous local retention of the drug, prolongs anti-inflammatory effects, and avoids the liver first-pass effect, which can help quickly improve airway inflammation. Contrary to other mucoactive drugs, NAC has been found to exhibit antioxidant, anti-inflammatory, antibacterial, and antibiofilm activities. In the respiratory infection field, the available data indicate that NAC was associated with inhibition of oxidative stress and reduced the inflammatory factors in community acquired pneumonia, antibiofilm activity specially in pseudomonas aeruginosa infection in pre-clinical and clinical reports and has good antibacterial properties and suggested to interfere with biofilm formation and disruption. NAC has shown improvement in the respiratory index (PaO₂/FiO₂), with lower rates of mechanical ventilation in COVID-19. When studied in mechanically ventilated patients with acute respiratory distress syndrome (ARDS), which is associated with oxidative stress, increased levels of glutathione, and inflammation, NAC demonstrated improvements in positive end-expiratory pressure (PEEP) and PaO₂/FiO₂. N-Acetylcysteine contributed to delaying ventilator-associated pneumonia (VAP) in mechanically ventilated patients when administered orally as a preventive medication. It was also effective in attenuating the decline in forced vital capacity (FVC) in mild to moderate idiopathic pulmonary fibrosis (IPF), and it showed a lower rate of postoperative pulmonary complications when given pre-operatively in orthotopic liver transplantation. Since NAC is relatively low-cost, readily available, and has a favorable side effect profile, it is important to properly assess the clinical benefits of nebulized NAC as an adjunct to standard medical treatments in mechanically ventilated patients. Aim of the study This study will assess the role of preventive N-acetylcysteine inhalation on incidence and time to develop VAP in critically ill mechanically ventilated patients. Objectives * 1\) Assessment of N-acetylcysteine inhalation efficacy in mechanically ventilated patients through monitoring the following parameters: time to develop ventilator-associated pneumonia (VAP), incidence of VAP, PaO₂/FiO₂, pH, oxygen saturation (SaO₂), peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), frequency of endotracheal tube (ETT) suction and tube exchange, and infection parameters (total leukocyte count, body temperature). In addition, hospital mortality, duration of mechanical ventilation (MV), ventilator-free days, and the length of hospital and ICU stay * 2\) Assessment of the safety of N-acetylcysteine inhalation in mechanically ventilated patients by monitoring the incidence of new-onset bronchospasm
NCT05819164
The oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Several factors can influence this measurement and the choice of ventilatory support: the type of oximeter used, skin pigmentation and the oxygenation goal. The objective of our study is to evaluate the impact of the oxygenation goal and the oximeter used on oxygen flows in patients with COPD (or with hypercapnia, or at risk of hypercapnia) and in patients without COPD (in particular pneumonia, pulmonary fibrosis and other pathologies) Our hypothesis is that the SpO2 target and oximeter used will have an impact on oxygen flows and that these effects will be synergistic in these different populations.
NCT07453966
The goal of this clinical trial is to learn whether adding intrapulmonary percussion ventilation (IPV) to standard airway clearance treatment improves clinical outcomes in invasively mechanically ventilated patients with pulmonary infection. It will also evaluate the safety of IPV in this population and assess changes in lung ventilation using electrical impedance tomography (EIT). The main questions it aims to answer are: Does adding IPV shorten the duration of invasive mechanical ventilation compared with standard therapy alone? Does IPV improve regional and global lung ventilation? Does IPV improve clinical indicators, including oxygenation, lung mechanics, and pulmonary infection scores? Is IPV safe in mechanically ventilated patients with pulmonary infection? Participants will: Receive either standard therapy alone or standard therapy plus IPV Undergo serial EIT monitoring at predefined time points Receive routine clinical assessments and ventilator parameter monitoring during ICU stay Be followed until successful weaning, discharge, or completion of hospitalization
NCT06867458
This is a single-center, non-blinded, prospective, pilot study enrolling patients admitted to the critical care unit at Royal Columbian Hospital. This study investigates the effects of universal nasal decolonization using antimicrobial photodynamic therapy (aPDT) on the prevention of hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP), and hospital-acquired bloodstream infection (BSI) in this patient population. Main Objectives include: * To determine whether a large, multi-center RCT of this protocol is feasible * To determine baseline rates of VAP, HAP, and ICU-acquired BSI * To gather preliminary efficacy data regarding VAP, HAP, and ICU-acquired BSI prevention using universal aPDT nasal decolonization * To gather preliminary microbiological data on the effect of universal aPDT procedures on nasal carriage of various microoganisms in ICU patients.
NCT07438834
Sedation is essential for mechanically ventilated pediatric patients to ensure comfort, ventilator synchrony, and prevention of self-extubation. However, excessive sedation may prolong mechanical ventilation and ICU stay, while inadequate sedation may cause agitation and physiological distress. Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI) are two commonly used strategies. Limited data exist comparing their impact on comfort levels in pediatric patients. This randomized controlled trial aims to compare comfort scores between continuous Midazolam infusion and daily sedation interruption in mechanically ventilated children aged 5-10 years diagnosed with pneumonia. Comfort will be assessed using the COMFORT-B Scale and Richmond Agitation-Sedation Scale (RASS) every 6 hours for 72 hours. The study intends to determine which strategy better maintains optimal sedation and comfort in pediatric intensive care settings.
NCT04335539
The primary objectives of this study are: * To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to \< 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to \< 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections * To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections
NCT05254990
Primary objective: \- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28. Key secondary objectives: * To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180. * To compare the efficacy of reparixin vs placebo in proportion of patients alive and discharged at day 28 * To compare the efficacy of reparixin vs placebo in ventilatory-free days at day 28. * To compare the efficacy of reparixin vs placebo in proportion of patients with IMV (or ECMO) by day 28. * To compare the efficacy of reparixin vs placebo in length of primary hospital stay. Other efficacy objectives \- To compare the efficacy of reparixin vs placebo on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: \- To evaluate safety and tolerability of oral reparixin versus placebo in the specific clinical setting.
NCT07425561
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods. The primary objective of the study is to derive a clinical predictive score for multidrug-resistant (MDR) pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
NCT02743507
Bundled payment is a new payment reform that encourages health care providers to improve quality and contain costs of care. These arrangements are being rapidly expanded across the country, but evidence about their impact are lacking. This study will use Medicare claims data to evaluate the effect of participation in a large Medicare bundled payment program on the quality and costs of care for common medical and surgical conditions.
NCT07403019
Trial Title: A Prospective Cohort Study To Compare The Burden Of Medically Attended and Community LRTI In Infants And Children Under 5 Years Of Age and adults (16-60 years) In India Primary Objectives: * To determine the population-based epidemiology, clinical features, and mortality of respiratory syncytial virus (RSV) lower respiratory tract illness (LRTI) in infants, children under 5, and adults (16-60 years) in rural India. * To calculate the incidence of RSV LRTI classifications (non-severe, severe, very severe, hospitalization, and mortality) per 1,000 child/adult years of observation. Secondary Objectives: • To determine the population-based epidemiology of human metapneumovirus (hMPV), SARS-CoV-2, and influenza LRTI in the same cohort. Study Design \& Methodology: * Type: Active surveillance, prospective longitudinal cohort study. * Setting: 30 villages in the Melghat region of Maharashtra, India, characterized by high infant and adult mortality rates. * Participants: All children under 5 years of age and adults aged 16-60 years residing in the study villages, including all newborns entering the cohort during the study period. * Procedures: \* Community Surveillance: Trained Village Health Workers (VHWs) will conduct weekly home visits to monitor respiratory health and identify potential LRTI cases. * Clinical Assessment: Supervisors will verify reported LRTI cases within 24 hours using standardized WHO classifications (non-severe, severe, and very severe pneumonia). * Medical Facility Monitoring: Hospital-based counselors will monitor all LRTI-related outpatient visits and hospitalizations from the study villages. * Sample Collection: Nasopharyngeal (NP) swabs will be collected from all identified LRTI cases (community and facility-based) and from any participant who dies within 15 days of an LRTI diagnosis. * Laboratory Testing: 2,000 samples will undergo real-time PCR screening and subtyping for RSV, hMPV, SARS-CoV-2, and influenza at the National Institute of Virology, Pune. * Mortality Investigation: For all participant deaths, a standardized verbal autopsy will be conducted to determine if LRTI was the cause of death. Statistical Plan: * Incidence rates and 95% confidence intervals will be calculated and severity category. * Results will be stratified by age, sex, and socioeconomic status * Multivariate analysis will be used Study Duration: 48 months total, including 36 months of active surveillance
NCT07186933
The goal of this clinical trial is to compare two different types of perioperative mechanical ventilation (MV), specifically Protective Mechanical Ventilation (PMV) and MV with the lowest possible Driving Pressure (ΔP), in relation to the appearance of postoperative pulmonary complications (PPCs) in adult patients who are operated and have higher risk of PPCs. The main questions it aims to answer are: * Is MV with lower ΔP better than conventional PMV in preventing PPCs in patients with higher risk for PPCs? * Does MV with lower ΔP decrease hospital stay, Intensive Care Unit (ICU) need and mortality? * Does MV with lower ΔP suit better than PMV to lung characteristics and needs intraoperatively? Researchers will compare MV with the lowest possible Driving Pressure (ΔP) to Protective Mechanical Ventilation (PMV) to see if any of this is more protective than the other concerning PPCs. All participants will receive perioperative MV. Half of them will receive conventional Protective Mechanical Ventilation (PMV). This will include well known generally protective settings for mechanical ventilation of patients, concerning volumes, pressures, respiratory rate, inspiratory gases and ventilation maneuvers. The rest of participants will be ventilated with the lowest possible Driving Pressure (ΔP). This will be similar to PMV in the chosen volumes, respiratory rate, inspiratory gases and ventilation maneuvers. However, the pressure inside lung at the end of expiration, eg Positive End Expiratory Pressure (PEEP), will be not be preset for every patient. Initially, the investigators will perform a maneuver that will quantify each individual's lung characteristics and mechanics. According to this, the investigators will find the exact PEEP that seems to suit each patients lungs most, and use this perioperatively, trying to provide lungs the best conditions every time. After the completion of the operation, all the patients will be screened for PPCs, via arterial blood testing and chest X ray, and the results will be statistically analyzed trying to find if any of the forementioned strategies of mechanical ventilation surpasses the other concerning PPCs appearance. PPCs include atelectasis, respiratory failure, bronchospasm, pleural effusion, pneumonia, aspiration and pneumothorax. Furthermore hospital stay, ICU need and mortality will be noted. Finally, measurements of perioperative lung pressures, volumes and derived variables will be noted and compared statistically as well.
NCT07399717
The main questions this study aims to answer are: * Does using probiotic nasal spray (LiveSpo Navax containing Bacillus subtilis and Bacillus clausii, 1x10\^9 CFU/mL), with or without oral probiotics (LiveSpo Pregmom containing Bacillus subtilis, Bacillus clausii, and Bacillus coagulans, 3x10\^9 CFU/5 mL), help children recover better from pneumonia when added to standard medical treatment? * Does using these adjunctive probiotics support reduce the recurrence of respiratory and gastrointestinal symptoms after hospital discharge? Researchers will compare three groups of children to see whether probiotic nasal spray alone or probiotic nasal spray combined with oral probiotics works better than placebo. All participants will receive standard medical treatment for pneumonia. In addition, they will be randomly assigned to one of three study groups to receive adjunctive probiotic support in 2 months: * Control group: receives a saline nasal-throat spray (0.9% NaCl) and oral placebo liquid (RO water). * Nasal probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray and oral placebo liquid (RO water). * Nasal plus oral probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray plus LiveSpo® Preg-Mom oral probiotic suspension. Participants will: * Use a nasal-throat spray three times a day. * Take an oral liquid twice daily. * Start using the study products during their hospital stay and continue for 8 weeks (2 months) from admission. * Be followed by the study team during hospitalization and at Day 30 and Day 60 after admission. The probiotic and placebo products look, smell, and taste the same so that neither the parents nor the study staff know which product each child receives.
NCT07395310
Based on our team's previous discovery of a unique type of squamous epithelial cell in the bronchoalveolar lavage fluid (BALF) of patients with aspiration pneumonia (AP) using microbiological rapid on-site evaluation (M-ROSE) technology-characterized by its distinct morphology and absence of bacterial adhesion on the surface-which we termed "showering cells," we designed a diagnostic test case-control study. Adult patients with pulmonary infection scheduled to undergo bronchoscopy were screened and allocated into an AP group (experimental group) and a non-AP group (control group). BALF sampling and M-ROSE slide preparation were performed following a standardized protocol. Microscopic examination was conducted to detect and manually count "showering cells." Simultaneously, a committee of respiratory and critical care medicine experts determined the gold-standard diagnosis (AP or non-AP) based on composite clinical criteria. A 2×2 contingency table was constructed to calculate sensitivity, specificity, positive/negative likelihood ratios, positive/negative predictive values along with their 95% confidence intervals, and the kappa agreement rate. A receiver operating characteristic (ROC) curve was plotted to evaluate the diagnostic performance of "showering cells" for aspiration pneumonia, from which the area under the curve (AUC) was calculated and the optimal cutoff value determined. This study aims to assess the diagnostic utility of "showering cells" and provide a novel cytomorphological tool for the diagnosis of aspiration pneumonia.
NCT06092008
Create a clinical diagnostic pathway for older ED adults with pneumonia and its subgroups (bacterial, viral, and co-infection) and determine whether novel biomarkers improve diagnostic accuracy. The investigators will conduct a prospective observational trial of 250 ED patients ≥65 years old with suspected pneumonia. The investigators will perform analyses overall and by subgroups, seeking common models to ease adoption.
NCT06169514
This is a mixed-methods program evaluation from a health systems and policy perspective, involving (i) stakeholder analysis, (ii) policy-implementation gap analysis, and (iii) comparative country case studies. This study aims to understand how national oxygen strategies achieve impact at national, and subnational level, across country contexts, at what cost. The the investigators seek to: 1. Involve policymakers, implementers (including private sector), and medical oxygen users in identifying challenges and understanding potential solutions to medical oxygen access; 2. Generate new data on how medical oxygen systems work and can be improved from multiple perspectives; 3. Draw lessons on medical oxygen that can directly inform national and global practice and policy. This study will be conducted in 6 of the 9 countries participating in the Clinton Health Access Initiative (CHAI) led Medical Oxygen Implementation (MOXY) program (Uganda, Nigeria, Rwanda, Liberia, Lao PDR, Cambodia). Key informants will be selected representing government, non-governmental agencies, professional associations, private sector, and civil society. This study will be completed over 4 years, with timelines varying between country study sites.
NCT07386912
The OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. By analyzing a single blood sample, the study examines how certain immune cells react during inflammation and infection, and whether lasting changes in these cells influence how strongly the body responds to disease. Although participants do not receive direct medical benefit, the results may help improve future diagnosis and treatment of lung diseases by providing deeper insight into immune responses.
NCT07369336
Article: Clinical Outcomes of Inhaled Amikacin in Ventilator-Associated Pneumonia: A group randomized controlled,add-on trial English:Patients in intensive care units often need ventilators to breathe. Sadly, these machines sometimes cause serious lung infections, known as ventilator-associated pneumonia (VAP). This study tested whether giving the antibiotic amikacin by inhalation (so itgoes straight into the lungs) could improve recovery when added to regular treatment. Researchers looked at how quickly infections cleared, how long patients needed the ventilator, and whether hospital stays were shortened. They also monitored for side effects.
NCT07369817
The goal of this study is to pilot test the feasibility of a mobile health clinical decision support tool called ALRITE for the diagnosis and management of acute lower respiratory illnesses in young children in Uganda. Asthma/wheezing illness, in particular, is underdiagnosed in this setting. The main questions the study aims to answer are: * Are the intervention structure, processes, outcomes, and implementations strategies feasible to conduct in the desired settings? * Does ALRITE increase the diagnosis of wheezing illness among children seen at Ugandan health centers? Researchers will compare outcomes before and after ALRITE deployment to healthcare workers at 4 Ugandan healthcare centers using an interrupted time series design. Study participants are healthcare workers. There will be12 months of baseline data collection ("baseline period"), at the beginning of which healthcare workers will be enrolled at each site. Following the baseline period, health workers will receive ALRITE training and will be encouraged but not required to use ALRITE in clinical care for a 6-month intervention period. Health worker participants will fill out surveys and participate in focus group discussions to provide feedback.