Merck Serono Co., Ltd For Recruiting Locations In, Japan

LUNG INFECTION in ICU (LUNG-I3)

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia

Pneumonia Direct Pilot

This is a prospective, observational, diagnostic, feasibility study to determine the accuracy of pathogen- and host-directed testing for the diagnosis of VAP. Newly intubated adult patients admitted to the ICU will be assessed for eligibility around the time of intubation according to the inclusion/exclusion criteria. Screening and consent can occur any time within 48 hours of a patient being intubated. Between 48 and 60 hours after intubation, eligible participants will have blood drawn and dedicated research aliquots from SOC ETS samples retrieved. The dedicated research aliquots from SOC ETS samples will be obtained simultaneously with routine sampling for microbiologic testing or, when this is not possible, during routine suctioning as a part of standard airway care. Collection of other clinical data may occur 24 to 72 hours after intubation. Participants will be followed daily for a clinical change for up to 14 days from the time of intubation. Clinical change is defined as a clinical suspicion of new-onset VAP that prompts the collection of lower respiratory tract secretions for routine microbiologic testing and initiation, continuation, or modification of antibiotic therapy for a pneumonia indication. Participants who experience a clinical change will have additional blood samples drawn and dedicated aliquots of the sample retrieved from standard-of-care ETS procedures. Additionally, if available, leftover bronchoalveolar lavage (BAL) will be reclaimed, and respiratory and blood bacterial isolates will be obtained from SOC cultures. Participants will be followed through the diagnosis of clinical change and finalization of all local microbiological and radiological results obtained as a part of usual care. Clinical data will be recorded through medical record review. Participants who do not experience a clinical change will be followed through extubation, ICU discharge, death, or for up to 14 days after intubation - whichever comes first. Participants who do not have a clinical change will not undergo additional sample collection. Clinical change events will be used to assess whether the participant meets the clinical case definition (FDA criteria) for VAP: VAP-positive (VAP+) or VAP-negative (VAP-) categories will be obtained by an algorithm linked to the eCRF data. The VAP clinical case definition will be adjudicated against the participants' clinical data and microbiological evidence and the certainty of the VAP diagnosis will be classified as follows: Prove, Probable, Possible VAP, or No VAP. Every participant with a clinical change will be assessed for the presence of an extrapulmonary infection. Extrapulmonary infection will be classified as follows: Proven, Possible, or No Infection. Evaluable participant specimens will be sent to a central laboratory for distribution to the testing centers that will perform the index testing. This study will compare pathogen-directed tests and host biomarker tests. Pathogen-directed tests detect and identify the most common causes of bacterial pneumonia, while host biomarker tests assess the host's immune response to infection. Testing centers will be blinded to whether the samples were collected at baseline or clinical change. Neither the study sites, participants, nor adjudicators will receive the results from the index testing.

Health Systems and Policy Contexts of Medical Oxygen

The investigators will use a concurrent mixed-methods design, with an overarching comparative case study methodology. The investigators will adopt an iterative approach, using co-design to adapt the study methodology to the specific context of each country and annual learning team meetings with stakeholders to refine the final case study topics (sub-study 3) and methodology. Three embedded sub-studies are planned: Sub-study 1 (Stakeholder Analysis) aims to understand the policy environment for medical oxygen services across different country contexts. This will be informed by the MOXY baseline survey, which includes data on oxygen-related facility readiness and clinical practices across the MOXY program areas. Data sources will include stakeholder interviews with participants from different levels (national, provincial, local) and policy perspectives (government, implementing/advising partners, practitioners, beneficiaries). Results will inform sub-study 2 and MOXY program implementation. Sub-study 2 (Policy-Implementation Gap Analysis) aims to critically analyse the gap between policy intentions and actual implementation. This will be informed by the baseline facility readiness and clinical practice data. Data sources will include a desk review of oxygen-related policies, stakeholder in-depth interviews, and program administrative data. Results will inform implementation of country oxygen strategies and feed into prioritization of focus areas for sub-study 3. Sub-study 3 (Comparative Country Case Studies) aims to compare oxygen programs across countries, focusing on particular challenges or unique solutions identified in sub-study 1 and 2. Data sources will include repeated desk review of oxygen-related policies and program administrative data, follow-up stakeholder interviews, and triangulation with quantitative survey results on facility readiness and clinical practices. This research will also draw on national stakeholder dialogues - both to review, refine, and validate preliminary findings of the study team and to draw out feasible solutions/alternatives for both policy and practice and oxygen eco-system. In year 1 the investigators will generate key evidence about how the current strategies and polices are being translated into action, identifying key opportunities for implementing partners to focus support. Over years 2 and 3, the investigators will learn how these activities have affected medical oxygen service coverage, drawing lessons across country contexts and across different implementation approaches.

Combined Effects Of Percussion With Diaphragmatic Breathing Exercises On Airway Clearance In Elderly Pneumonia Patients

It will be a randomized clinical trial. And the data will be conducted from Mayo Hospital Lahore. Convenient sampling technique will be applied on patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A and group B to collect data. For this purpose, I will divide my sample size into two groups. The group A will receive percussions and diaphragmatic breathing with 1 session a day for 3 days in a week for 4 weeks. In this way total 12 sessions will be given to the patients. And group B will receive only diaphragmatic breathing with 1 session a day for total 3 days in a week for 4 weeks. By this intervention procedure, I will find out the effects of these techniques on airway clearance of the pneumonia patients, their effect on the quality of life and on Dyspnea. For this I will use 4 tool questionnaires that are 1-BCSS, 2- Modified Borg Dyspnea scale, 3-Rate of perceived exertion scale, 4- Health-related Quality of Life-14. BCSS will be used to assess breathlessness, cough and sputum retention. Modified Borg Dyspnea scale is 0-10 rated numerical scale used to measure Dyspnea. RPE is a way to measure the level of exertion a person feels during physical activity. HRQOL-14 will assess the quality of life of the pneumonia patients. Before and after each session, the primary and secondary outcomes will be measured for both groups. After collecting the data, the data will be analyzed by using SPSS version 25.

Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU

Rationale: Ventilator-associated pneumonia (VAP) is the most common hospital-acquired infection (HAI) in the intensive care unit (ICU), and its impact is very high in terms of morbidity, length of hospital stay and overall costs. Minimising manipulation and disconnection of the ventilator circuit by reducing the frequency of HME filter exchange may lower the risk of its secondary contamination, hence the incidence of VAP, while maintaining its efficacy in terms of sufficient humidification of the inhaled gas mixture and safety in terms of no or minimal change in resistance to airflow. Aim: To test the effectiveness and safety of prolonged (72-hour exchange interval) use of a single HME. Design: Prospective, single-centre, parallel-group randomised controlled trial. Subjects: ICU patients (general ICU) Treatment in the intervention group: HME filter exchange every 72 hours Control group: Standard-of-care: daily HME filter exchange Primary outcome: 1. Presence of HME-associated adverse events (a composite endpoint of endotracheal tube occlusion or nosocomial tracheobronchitis or pneumonia). 2. The cumulative incidence of lower respiratory tract microbial colonisation analysed by the Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h. Secondary and exploratory outcomes: Differences in the relative risk of infection-related ventilator-associated complications, antibiotics (ATB) exposure analysis, length of ICU stay in days (time frame: three months), number of ventilator-free days (time frame: 28 days); differences in the incidence of endotracheal tube occlusion necessitating reintubation between individual groups, differences in airway resistance, humidity delivered to the patients and efficacy of HMEs between groups

Combined Effects of Balloon Blowing Therapy With Percussion in Patients With Pneumonia

Pneumonia is an infection of the lungs that is caused by bacteria, viruses, fungi, or parasites. It is characterized primarily by inflammation of the alveoli in the lungs or by alveoli that are filled with fluid (alveoli are microscopic sacs in the lungs that absorb oxygen). The symptoms of pneumonia can develop suddenly (over 24-48 hours) or may show more slowly, over several days. Common symptoms of pneumonia are likely to have a cough which can be dry, or may produce phlegm (thick mucus) that is yellow, green, brownish or bloodstained and breathing difficulty, wheezing and chest tightness where the rate will be high and the rhythm will be rapid and shallow. This activity encourages deep breathing, allowing a patient body to relax. Explain the patient that this exercise will help him or he can feel more relaxed. Make the patient to imagine that he/she is blowing up a balloon. Ask him/her to take in a deep breath; steadily and slowly blow up the huge balloon. See the balloon getting bigger, and bigger. Now ask the patient to close the eyes and imagine the balloon floating into the air. Let the patient continue blowing of balloons until he or she gets relaxed and calm. Percussion is a technique involving rhythmic tapping or clapping on the chest or back, serves as a means to move and loosen retained secretions within the airways. This mechanical intervention helps in removing mucus from the bronchial walls, and facilitates its expectoration and clearance. This research methodology is likely to employ a randomized clinical trial design, dividing participants into two groups: group A will be receiving the combined therapy (Balloon blowing, percussion) for 7 days, while the Group B will be given intervention as Buteyko breathing techniques (ACBT, Percussion and deep breathing) for 3 weeks. Parameters such as breath auscultation by stethoscope, CASA Q questionnaire, Pulmonary function test will likely be utilized to gauge the efficacy of the combined intervention versus standard treatments. Anticipated outcomes encompass improvements in lung function metrics, clearer breath sounds denoting improved airway clearance, and potentially quicker recovery or shortened illness duration as compared to conventional treatments. If successful, this study could signify a more comprehensive and effective approach to manage pneumonia by combining specific therapies to enhance pulmonary functions and help in patients' recovery. Ultimately, these findings could contribute significantly to use respiratory therapy for individuals suffering from pneumonia

Comparative Effects of Blow Bottle and Acapella Along With Diaphragmatic Breathing in Patients With Pneumonia

A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study

Mycoplasma pneumoniae (M. pneumoniae) is the most frequently detected bacterial pathogen in community-acquired pneumonia (CAP) in hospitalized U.S. children. Prior to the COVID-19 pandemic, M. pneumoniae was responsible for 8-28% of childhood CAP and thus was substantially contributes to CAP being a leading cause of hospitalization in high-income settings and worldwide morbidity and mortality. After the corona virus disease (COVID)-19 pandemic, M. pneumoniae and its delayed re-emergence remains a thread to children's health. CAP accounts for more treatment days with antibiotics in children's hospitals in the U.S. than any other condition. Macrolides are the first-line treatment for M. pneumoniae infection. Still, there is a lack of evidence for macrolides' the effectiveness in the treatment of M. pneumoniae induced CAP; simultaneously there is an alarmingly increasing antimicrobial resistance among M. pneumoniae. Therefore, childhood CAP, and especially M. pneumoniae, is an important target for antimicrobial stewardship efforts and cost-effectiveness considerations. The MYTHIC Study is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial in 13 Swiss pediatric centers. Previously healthy ambulatory and hospitalized children aged 3-17 years with clinically diagnosed CAP will be screened for a M. pneumoniae infection with Immunoglobulin M (IgM) lateral flow assay. Patients will be randomized 1:1 to receive a 5-day-treatment of macrolides (azithromycin) or placebo.