Clinical Research Directory

Wells and Enteric Disease Transmission Trial (WET - Trial)

Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.

Dime La VerDAD: Verify, Debunk, and Disseminate

Dime la Verdad (Tell me the truth) will evaluate the use of storytelling by community health workers as a communication strategy to disseminate reliable health information on social media and encourage informed decision-making in favor of recommended immunizations in communities with high morbidity and mortality due to respiratory virus infections. Dime La Verdad is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers community health workers to disseminate reliable information about respiratory virus protection strategies through the use of personal narratives on social media. The proposed work will use a rigorous stepped wedge design to 1) deliver a scalable program of science communicators using an adapted curriculum grounded in principles of health communication, 2) evaluate how diffusion of health messaging is perceived on social media, and 3) discern how use of personal narratives to enhance science communication can encourage informed decision-making to promote evidence-based immunization practices and improve health outcomes.

Reducing Respiratory Virus Transmission in Bangladeshi Classrooms

This study will test if affordable air cleaning devices (box fans with a filter attached and/or ultraviolet light lamps) installed in classrooms can reduce the number of viral respiratory illnesses schoolchildren experience.

Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis

Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure. CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated. A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival. The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF. About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.

A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses

A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.

Wells and Enteric Disease Transmission

Approximately 40 million people in the US are served by private, and frequently untreated, wells. Our best estimate is that 1.3 million cases of gastrointestinal illnesses (GI) per year are attributed to consuming water from untreated private wells in the US, but in reality, there are no robust epidemiological data that can be used to estimate cases of GI attributable to these sources. We propose the first randomized controlled trial (RCT) to estimate the burden of GI associated with private well water. We will test if household treatment of private well water by ultraviolet light (UV) vs. sham (inactive UV device) decreases the incidence of GI in children under 5. We will also examine the presence of viral, bacterial, and protozoan pathogens in stool and well water from participants. These data will fill a knowledge gap on sporadic GI associated with federally-unregulated private water supplies in the US.

Assessment of the Type I IFN Response in the Nasal Cavity During Respiratory Viral Infections in a Geriatric Department

The diagnosis of respiratory viral infections is usually based on testing for pathogens suspected of causing the infection using PCR tests that target the pathogens' DNA or RNA. A specific PCR test is required for each pathogen. In most cases, testing is carried out primarily for three specific viruses (SARS-CoV-2, respiratory syncytial virus (RSV), influenza virus) is carried out as a first-line test. However, numerous viruses can cause these infections (adenovirus, metapneumovirus, rhinovirus, parainfluenza virus, bocavirus, etc.). Consequently, performing a specific PCR test for every virus that could cause respiratory symptoms is not feasible, and viral infections are often under-diagnosed because the screening for viruses is not exhaustive. To address this issue, analysing the host response to determine the microbial aetiology of an infection may represent an innovative alternative for the diagnosis of infections. A common feature of all viruses is their ability to induce type I interferons (IFN-I). Thus, measuring this IFN-I response could help direct the diagnosis of respiratory infections towards a viral origin. Furthermore, the detection of a virus via PCR in a respiratory sample may indicate an active or recent infection, but may also be detected following an infection that occurred several weeks or months earlier. The viral load in the sample is an important factor in distinguishing between these two scenarios but does not always allow for a definitive conclusion (some patients may have low viral loads whilst still having an active infection). It is therefore sometimes difficult to distinguish, using a PCR test that detects the viral genome, between the virus currently replicating and traces of viral genetic material from dead viruses. It is therefore necessary to have markers that can be associated with an active/replicating infection to aid interpretation in the event of a positive PCR result. Using nasopharyngeal swabs collected for the diagnosis of SARS-CoV-2 infection, we were able to demonstrate that it is possible to measure the IFN-I response. These proteins, which possess antiviral properties, are secreted by immune cells during infection to limit viral replication. Thus, the combination of simultaneous testing for the pathogen and the IFN response has made it possible to link the replicative nature of the SARS-CoV-2 virus with IFN-I production. Our latest research into SARS-CoV-2 has thus led to the identification of a marker of the IFN-I response associated with active viral replication, which we have confirmed using viral culture techniques that detect only live/infectious virus. However, the IFN-I response may be compromised in older and very old individuals, particularly due to certain comorbidities or treatments, the prevalence of which increases with age. The aim of this study is to assess the IFN-I response in the context of respiratory infections caused by various viruses, in a population admitted to a geriatric ward and a population from the REFIPA protocol (NCT07239830), a study designed to establish reference values for nasal and blood interferon scores in uninfected elderly subjects. There is a need to improve the diagnosis of viral infections, particularly in geriatric wards where the burden of viral infections is very significant for patients, carers and the organisation of care. Rapid diagnosis of viral infections would enable the optimisation of isolation measures and hygiene protocols within these wards. Furthermore, it is important to validate new markers that could aid in the interpretation of a positive PCR result for respiratory viruses. Some PCR tests can indeed remain positive for several weeks or even months due to the detection of traces of viral genetic material. Thus, new markers indicating an active or recent infection could be useful in facilitating interpretation, alongside other clinical and/or virological findings. The aim is, by combining different results, to improve the diagnosis of viral infections and to avoid over-diagnosing respiratory viral infections due to a positive PCR result that may in fact correspond to a past infection.

Macrophage Regulation of Ozone-Induced Lung Inflammation

The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.

Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years of Age With Influenza

The goal of this phase III study is to learn if ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years. The main question it aims to answer is: What medical problems do participants have when taking drug ZX-7101A for oral suspension or Oseltamivir phosphate for oral suspension? Researchers will compare drug ZX-7101A for oral suspension to active comparator: Oseltamivir phosphate for oral suspension to see if drug ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.

Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza

The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: * To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. * To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)

Study design is multicenter prospective registry study. Participants are consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria. The primary objectives are to estimate the prevalence of and risk factors for RS and other respiratory virus infection and their effect on hospital course in patients with any respiratory symptom who admit from emergency room using a multicenter prospective registry study. The primary target virus is RS virus and the secondary target viruses are respiratory virus and other microorganisms measured by FilmArray 2.1.

Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.