Clinical Research Directory

Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mechanical Ventilation

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

Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)

The Hyper IgE Syndromes (HIES) are primary immunodeficiencies resulting in eczema and recurrent skin and lung infections. Autosomal dominant Hyper IgE syndrome (AD-HIIES; Job's syndrome) is caused by STAT3 mutations, and is a multi-system disorder with skeletal, vascular, and connective tissue manifestations. Understanding how STAT3 mutations cause these diverse clinical manifestations is critical to our complete understanding of bone metabolism, bronchiectasis, dental maturation, and atherosclerosis. Bi-allelic mutations in DOCK8 cause a combined immunodeficiency previously described as autosomal-recessive Hyper IgE syndrome. These individuals suffer from extensive viral infections as well as have a high incidence of malignancy and mortality. The pathogenesis of this disease and long-term natural history is being investigated. Therefore, we seek to enroll patients and families with a confirmed or suspected diagnosis of HIES syndrome for extensive phenotypic and genotypic study as well as disease management. Patients will be carefully examined by a multidisciplinary team and followed longitudinally. Through these studies we hope to better characterize the clinical presentation of STAT3-mutated HIES, DOCK8 deficiency and other causes of the hyper IgE phenotype, and to be able to identify further genetic etiologies, as well as understand the pathogenesis of HIES. We seek to enroll 300 patients and 300 relatives....

Trial of Reducing Inpatient Antibiotic Durations in Children

Infections like pneumonia, skin and soft tissue infection (also called SSTI or cellulitis), and urinary tract infections (UTI) are some of the most common reasons children get admitted to the hospital. All three of these conditions require antibiotics for treatment. Although antibiotics are needed to treat the infection and help children feel better, taking them longer than needed can negatively impact children and their families. Negative impacts include things like the burdens of taking more medications and medication side effects. There are guidelines (instructions) from expert medical organizations that suggest the number of days children need antibiotics, but they give a wide range (between 5 and 14 days). Unfortunately, these guidelines are not based on high-quality studies. National data suggests that doctors often choose on the higher end of this range when writing prescriptions for children in the hospital. Our three caregiver co-investigators, other parents of hospitalized children, doctors, other care providers, and researchers, all believe that additional study is needed to determine the best length of antibiotic treatment that weighs both the benefits and harms of antibiotics. The goal of our study is to understand if 5 total days of antibiotic treatment compared to 10 total days of antibiotic treatment is better for children who have been in the hospital for pneumonia, SSTI, or UTI. We will study this question through a randomized control trial. In other words, half of the children will receive 5-days of antibiotics and the other half will receive 10-days of antibiotics. Children in this study (and their caregivers) will not know how many days of antibiotics they will receive to cure their infection because some children will take a placebo (or a pill without antibiotics in it). Only the pharmacy will know if a child is getting antibiotic or placebo (for days 6-10 of treatment). During the first phase of the trial (feasibility phase), 4 hospitals will enroll children in the study. We plan on enrolling 50 patients during this phase. We are starting with just 4 hospitals, so our study team can create and update our study plans if needed. We will closely review information about how many patients and families agree to participate, and if they have any trouble completing any part of the study. We will also interview families to understand the choice to participate in the study, the choice not to participate in the study, and what it is like to be in the study. During the second study phase, we will enroll 1150 more patients across all 11 hospitals. Families will complete short, daily surveys until the 15th day after they started antibiotics, then a larger survey at day 15, at day 20, and at day 30. These surveys will ask about the child's symptoms and recovery from their illness, how the antibiotics are making them feel, and if they had to go back to their doctor, emergency room, or hospital. The answers to these questions will be combined to measure how well the child did, balancing feeling better and having bad effects from the antibiotics. We will use mathematical tests to determine which antibiotic duration is better for treating these illnesses. We will complete other mathematical tests to see if all children should receive the same length of antibiotics or if certain children should be prescribed shorter courses and others longer courses.

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Study of Lung Proteins in Patients With Pneumonia

This study will examine the different types of proteins present in the lungs of patients with pneumonia to explore the causes of different types of the disease. Pneumonia is a condition that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by lung x-rays and listening to the chest with a stethoscope. This method can diagnose pneumonia, but it does not provide information on the cause of the inflammation - information that might be helpful in guiding treatment. This study will measure proteins in the lungs of patients to see if certain proteins are associated with specific forms of pneumonia, and can thus serve as biomarkers for disease. Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for their medical care. For this procedure, the patient's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Saline (salt water) is then injected through the bronchoscope into the air passage, acting as a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content. In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2 tablespoons of blood drawn to compare blood test results with the results of the lung washings. Patients' medical records will be reviewed to obtain information on past medical history, current medical treatment, vital signs, and results of x-ray tests. ...

Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

Pneumonia is a major cause of illness and death in children, with an annual incidence of about 3.3 per 1,000 in those under five years old, many requiring hospitalization. The diagnosis is challenging due to the absence of a universally accepted gold standard, leading to variability in emergency settings. Current guidelines recommend diagnosis based on history and physical examination, which do not reliably differentiate pneumonia from other respiratory infections or identify whether it is bacterial or viral in nature. This uncertainty can lead to the unnecessary use of antibiotics. Commonly used chest X-rays have limitations such as low sensitivity, moderate interobserver reliability, and the inability to distinguish bacterial from viral pneumonia. In contrast, lung ultrasound has shown high sensitivity and specificity for diagnosing pneumonia in children. However, lung ultrasound also cannot reliably distinguish between bacterial and viral causes and might lead to increased antibiotic prescriptions by detecting minor lung consolidations not seen on chest X-rays. Despite these issues, lung ultrasound is widely used in pediatric pulmonary assessment. The primary objective of the study is to determine if using lung ultrasound for diagnosing pneumonia in children can reduce antibiotic prescriptions compared to the standard care approach-which mainly relies on clinical diagnosis (often supplemented by chest X-ray and blood tests in selected cases). The secondary objective is to assess how frequently lung ultrasound impacts management decisions during a single clinical visit, beyond the information provided by history and physical examination. The third objective is to compare the diagnostic accuracy of lung ultrasound-supported diagnosis with existing diagnostic methods. The study hypothesizes that lung ultrasound results can act as a decision modifier, similar to other clinical tools and examination findings. However, a lack of consensus on specific lung ultrasound parameters and their clinical correlations contributes to variability in managing suspected pneumonia, potentially leading to antibiotic overuse. Eligible participants are children aged three to ten years who are in good general condition and clinically stable, presenting with signs and symptoms of lower respiratory tract infection indicative of pneumonia. Exclusion criteria include children outside the specified age range, those recently hospitalized, those who have undergone prior chest imaging, those already on antibiotic therapy, those with severe clinical instability, and those with underlying conditions predisposing them to severe or recurrent pneumonia. These criteria help ensure that the study population represents general pediatric community-acquired pneumonia cases, avoiding biases from high-risk patients. The ultimate goal of this study is to provide evidence on whether lung ultrasound can serve as a reliable tool to guide antibiotic prescriptions, thereby reducing unnecessary antibiotic use in the management of pediatric pneumonia.

Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO

The standard and most common therapy is anticoagulation with heparin according to activated partial thromboplastin time (aPTT) during extracorporeal membrane oxygenation (ECMO) support. The study will focus on evaluating the efficacy and safety of new anticoagulants on ECMO, namely argatroban and enoxaparin in lower doses controlled according to targeted antiIIa and antiXa markers.

Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults

People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality. Several modifiable factors increase this risk, including active smoking, inadequate receipt of respiratory vaccinations, and inappropriate or prolonged use of inhaled corticosteroids (ICS) or proton-pump inhibitors (PPIs). OPTIMIZE Lung-HIV is a multicenter, patient-level randomized controlled hybrid Type 1 effectiveness-implementation trial evaluating whether a proactive, pharmacist-led E-consult intervention can improve evidence-based pulmonary pharmacotherapy for PWH. Pharmacists will review electronic health records, generate tailored recommendations, and pre-enter orders related to smoking cessation pharmacotherapy, vaccinations, and deprescribing of ICS or PPIs. Providers may enact or modify recommendations as clinically appropriate. The trial will assess the proportion of recommendations enacted within 3 months (primary outcome) and at 12 months (maintenance) and will use mixed methods guided by CFIR and RE-AIM to evaluate adoption, feasibility, acceptability, and implementation barriers and facilitators.

A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia

The purpose of this study is to learn how effective is PCV20 to help stop adults from getting pneumonia. Pneumonia is an infection of the lungs that can be caused by germs like bacteria, virus, or fungi. This study uses existing healthcare information. No participants will be actively enrolled. The information of participants will be taken from Kaiser Permanente Southern California's (KPSC) electronic health records (EHR). We will look at the EHR information for adults who meet the following points: * 18 years of age or older and a KPSC member as of 01 July 2022. * have been a KPSC member for at least one year before 01 July 2022. * have not received PCV15. * have had pneumonia or lower respiratory tract infection within 30 days of 01 July 2022. The study will begin from 01 July 2022 and will be followed through 30 June 2025. At the end of the follow-up period, the study will compare the number of pneumonia cases among people who receive PCV20 who do not receive it.

Study of the Characteristics of Acute Mycoplasma Resuscitation: ECRAN-PLASMA Study

The ECRAN-PLASMA study aims to analyze the characteristics of patients with Mycoplasma pneumoniae or Chlamydia pneumoniae pneumonia hospitalized in intensive care units (ICU), continuous monitoring units (USC), or intensive pulmonary care units (USIP). It evaluates their management, prognosis, and macrolide resistance rates.

A Clinical Cohort Study of Pneumonia in Respiratory Intensive Care Unit

From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical character has changed quietly, especially severe pneumonia. This cohort study aim to obtain the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through the clinical data analysis, the investigators could get the information of the pneumonia caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms and radiographic changes, the respiratory support parameter and so on. The investigators hope the result could guide them do the clinical work of severe pneumonia better in the future.

Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC)

The Next Day Clinic (NDC) is a quality improvement initiative that will be launched and operated by UCLA Health starting July 22, 2024. Its goals are to improve patient care and safety and to maximize cost effectiveness. The way it does this is by identifying patients in the ED who would normally be admitted for low-acuity conditions, and diverting them to a high-acuity clinic the following day called the NDC. This will help decompress the ED and the hospital, and allow for overall higher quality care. The Health System has partnered with UCLA's Healthcare Value Analytics and Solutions \[UVAS\] group which specializes in these types of program evaluations. The analysis conducted by the study team will be used to directly inform NDC operations, scaling, and future plans.

Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia

This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay

Effectiveness of Chatbot for Improving Caregiving Outcomes in Primary Caregivers of Geriatric Pneumonia Patients: A Study on Knowledge, Attitude and Practice.

Pneumonia is a leading cause of death and hospitalization among the elderly in Taiwan. High-quality home care is essential to recovery and reducing readmission, yet primary caregivers often lack the specific skills needed, such as airway clearance and safe feeding techniques. Traditional education, consisting of one-time verbal instructions and paper brochures, often lacks interactivity and real-time support. This study introduces "Pneumonia Care Helper," an interactive LINE chatbot designed to provide digital health education. The goal is to evaluate whether this digital tool is more effective than traditional paper-based education in improving the knowledge, attitudes, and caregiving practices of primary caregivers of elderly pneumonia patients. The study will compare the outcomes of caregivers using the chatbot versus those receiving standard paper-based instructions over a 5-day intervention period.

iNO300 Therapy in Critically Ill Patients With Pneumonia

The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive high doses of inhaled nitric oxide (iNO) therapy at 250 parts per million (ppm), not exceeding 300 ppm. Meanwhile, the benefits of the therapy to treat severely sick patients with pneumonia will be explored. Patients who are 18 years or older, newly diagnosed with pneumonia, and severely sick with requirement of a breathing machine could be included. The main questions it aims to answer are: How does methemoglobin change through the iNO treatment? Does iNO therapy increase the number of patients recovering from pneumonia? Researchers will compare iNO treatment to placebo, which means using the same device as the treatment group without delivering the study drug. Participants will: * Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5 * Be followed up for 60 days

Risk of Pneumonia in Intubated Patients in Emergency Situations

Orotracheal intubation in emergency medicine is a vital procedure for ensuring adequate oxygenation and ventilation in patients with respiratory distress or in shock. However, this procedure exposes patients to complications such as pneumonia. In the matter of fact, the urgency of the procedure means that it is not possible to wait until the patient's stomach is empty. Pneumonia significantly increase patient morbidity and mortality. Therapeutic management must be early and appropriate to improve the patient's prognosis. The aim of this study is to compare the rate of pneumonia occurring in patients intubated in emergency situations with that in patients intubated in non-emergency situations in all 2024. Health data will only collected from patient's medical records.

Continuous Sedation vs Daily Sedation Interruption in Ventilated Children

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.

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).

Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.

Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator. The 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted/controlled mode and weaning under partial pressure support or volume support, followed by monitoring period until ICU discharge, hospital discharge or 30 days. The study design differentiates between a Validation Cohort (up to 20 participants) for device validation and a Study Cohort (up to 61 participants) for safety and performance confirmation. Serious Adverse Events related to study device and/or its procedure is defined as the primary safety endpoint, whereas technical failure rate is defined as the primary performance endpoint.

A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.

Lung cancer remains the leading cause of cancer-related death in the UK, with over 35,000 deaths annually and most cases diagnosed at a late stage. Current screening programmes using low-dose CT scans target only high-risk individuals, missing around 30% of lung cancer cases, including many women and never-smokers. There is no simple, non-invasive tool to help triage patients with persistent respiratory symptoms who fall outside formal screening criteria. Inflammacheck® measures hydrogen peroxide and other breath biomarkers linked to airway inflammation and oxidative stress. Preliminary studies (VICTORY and ExPeL) have shown strong diagnostic performance for distinguishing lung cancer from other respiratory conditions. VICTORY 2 aims to validate and refine the AI model supporting Inflammacheck®, enabling accurate, rapid, and affordable triage for suspected lung cancer in NHS settings.

The Impact of Bundled Payments on Quality and Cost of Care

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.

The APS Phenotyping Study

The goal of the observational APS phenotyping study is to better understand risk factors, potential biomarkers, length and severity of illness, and recovery for adults with ARDS, pneumonia, and/ or sepsis. This study will also generate a biobank of specimens collected from these patients that will be available to investigators for future studies of ARDS, sepsis, and/or pneumonia.

PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms

In North America, up to 5% of preschoolers develop community-acquired pneumonia (CAP) every year. Pneumonia is the second-leading reason for paediatric hospitalization in both Canada and the US; approximately 20% of children hospitalized with CAP may need intensive care, which can result in significant morbidity. Given this burden of disease, it is critical that CAP is managed appropriately. Specific therapy for CAP is dependent on microbiologic aetiology, as bacterial disease will improve with antibiotic treatment.

Flexible Bronchoscopy in Resistant Pneumonia in PICU

Pneumonia is one of the most common and serious infections in children, especially those admitted to Pediatric Intensive Care Units (PICUs). Some children do not improve after at least five days of appropriate broad-spectrum antibiotic treatment. This condition is known as resistant or non-resolving pneumonia. Flexible fiberoptic bronchoscopy (FFB) is a procedure that allows doctors to directly examine the airways and collect samples from the lungs for laboratory testing. This study aims to evaluate the role and usefulness of flexible bronchoscopy and bronchoalveolar lavage (BAL) in identifying the causes of resistant pneumonia in critically ill children. The study will include children admitted to the PICU at Abu El-Reesh Children's Hospital, Cairo University, who show no clinical or radiological improvement after five days of first-line antibiotic therapy. The results of this study may help improve diagnosis, guide targeted treatment, and enhance outcomes in children with resistant pneumonia.