Ongoing Clinical Trials for Respiratory Tract Infection
There are currently 7 ongoing clinical trials studying treatments and prevention strategies for respiratory tract infections. These trials are testing various medications including bacterial lysates, nasal sprays, and immunostimulants across multiple countries in Europe. The studies focus on different age groups, from infants to elderly patients, and cover conditions ranging from recurrent infections to severe pneumonia and COVID-19.
Clinical trial locations
- Belgium
- Croatia
- Czechia
- Estonia
- France
- Germany
- Study on Nitric Oxide and Saline Nasal Sprays for Treating COVID-19 and Similar Illnesses in Primary Care Patients
- Study on the Effects of Baricitinib and Drug Combination for Adults with Severe Community-Acquired Pneumonia, Severe Influenza, or Severe and Moderate COVID-19
- Study on OM-85 for Preventing Respiratory Infections in Children with Wheezing Illness (Ages 6 Months to 5 Years)
- Hungary
- Ireland
- Italy
- Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults
- Study on Preventing Respiratory Infections in Elderly Patients Using OM85
- Study on the Effects of Baricitinib and Drug Combination for Adults with Severe Community-Acquired Pneumonia, Severe Influenza, or Severe and Moderate COVID-19
- Study on the Safety of Mercaptamine with Standard Therapy for Hospitalized COVID-19 Pneumonia Patients Not Requiring High Oxygen Flows
- Study on OM-85 for Preventing Respiratory Infections in Children with Wheezing Illness (Ages 6 Months to 5 Years)
- Netherlands
- Poland
- Portugal
- Romania
- Slovenia
- Spain
Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults
This study is testing a medication called Buccalin to see if it can help prevent repeated lower respiratory infections in adults. These infections include conditions like acute bronchitis and flare-ups of chronic lung diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD).
Main inclusion criteria: Adults aged 18 to 99 years can join if they have experienced 2 or more episodes of lower respiratory infections in the past 12 months. These infections must be confirmed by appropriate microbiological tests. Patients should be willing to provide informed consent and follow the study requirements. Previous vaccinations are allowed for anti-pertussis, Covid-19, Respiratory Syncytial Virus, influenza, or pneumococcal vaccines.
Main exclusion criteria: People cannot participate if they have a history of allergic reactions to any ingredients in Buccalin, are currently taking medications that might interfere with the study drug, have serious health conditions that could affect safety, are pregnant or breastfeeding, have participated in another clinical trial within the last 30 days, or are unable to follow the study procedures or attend required visits.
Trial focus: The study will last 12 months and aims to determine whether Buccalin can reduce the number of infection episodes compared to a placebo. Researchers will also monitor the duration of each infection, the number of antibiotic treatments needed, and the number of sick days. Participants will rate their health condition on a scale from 0 to 10 throughout the study. The safety of Buccalin will be carefully evaluated by monitoring any side effects.
Investigational drug: Buccalin is an immunostimulant tablet designed to boost the body’s immune system to better defend against lower respiratory infections. It works at the molecular level by stimulating immune responses in the respiratory tract.
Study on Nitric Oxide and Saline Nasal Sprays for Treating COVID-19 and Similar Illnesses in Primary Care Patients
This trial is investigating a Nitric Oxide Nasal Spray (NONS) for treating COVID-19 and COVID-like illnesses. The study will compare it with a simple saltwater nasal spray to evaluate how quickly patients recover from their symptoms.
Main inclusion criteria: Participants must be at least 18 years old with at least two symptoms suggesting COVID-19 or a similar illness. One symptom should be respiratory (like cough or sore throat) and another should be a general symptom (like fever or tiredness). A qualified healthcare provider must confirm the illness is due to a respiratory infection. Symptoms must have started less than 7 days ago. Participants need a freezer at home to store self-collected samples. Women who can become pregnant must use reliable birth control for 30 days before and after joining the study.
Main exclusion criteria: People without symptoms of COVID-19 or COVID-like illness cannot participate. Participants must fall within specified age ranges. Both males and females are eligible, but other gender identities may not be able to participate. Vulnerable populations requiring special protection or care are not eligible.
Trial focus: The study will monitor participants for up to seven days as they use the nasal sprays. Researchers will track how quickly participants feel better, how the treatment affects the virus in their bodies, and its impact on illness severity and immune response. The study will also explore any long-term effects such as fatigue or loss of taste and smell. Data on viral clearance and symptom severity will be collected at specific intervals on days 4, 7, and 14.
Investigational drugs: The trial tests several medications including remdesivir (an antiviral that interferes with viral replication), dexamethasone (a corticosteroid that reduces inflammation), baricitinib (reduces inflammation by blocking certain enzymes), tocilizumab (targets proteins involved in inflammation), and favipiravir (an antiviral that inhibits virus replication).
Study on Preventing Respiratory Infections in Elderly Patients Using OM85
This study is testing OM85, a medication made from bacterial lysates, to see if it can reduce the number of respiratory infections in elderly patients living in healthcare residences who have experienced at least two such infections in the past year.
Main inclusion criteria: Participants must be 75 years or older and have had at least 2 respiratory infections in the year before joining. They must have lived in a healthcare residence for at least 6 months and be expected to stay for at least another 6 months. Signed informed consent is required; if a participant cannot provide consent due to cognitive issues, a legally recognized representative or patient trustee can provide it. Participants must have a life expectancy of at least one year as determined by a doctor.
Main exclusion criteria: Patients who have not had at least two infections of the respiratory system in the past year, have not lived in a healthcare residence for at least 6 months, or are not elderly cannot participate.
Trial focus: The treatment period lasts 6 months, followed by a 6-month observation period. The main goal is to see if OM85 can lower the number of respiratory infections over the full 12-month period. The study will also track hospital admissions, emergency room visits, and antibiotic use. Researchers will review medical records to check for any side effects in elderly patients.
Investigational drug: OM85 is administered orally in capsule form with a dosage of 7 mg. It is an immunostimulant that works by stimulating the immune system, enhancing the body’s natural defense mechanisms against respiratory pathogens.
Study on the Effects of Baricitinib and Drug Combination for Adults with Severe Community-Acquired Pneumonia, Severe Influenza, or Severe and Moderate COVID-19
This large multi-country trial is studying treatments for severe respiratory illnesses including severe influenza, severe and moderate COVID-19 infection, and severe community-acquired pneumonia. The study aims to improve health outcomes for seriously ill patients admitted to intensive care units.
Main inclusion criteria: Adults admitted to an ICU for severe community-acquired pneumonia within 48 hours of hospital arrival can participate. Patients should have symptoms like sudden difficulty breathing, cough, or sharp chest pain, along with X-ray evidence of a new lung infection. Within 48 hours of ICU admission, patients should be receiving organ support such as ventilatory support or medications that help the heart pump blood (vasopressors or inotropes). For pandemic-affected patients, adults admitted with acute illness due to suspected or confirmed pandemic infection are eligible.
Main exclusion criteria: Patients without severe influenza, severe or moderate COVID-19, or severe community-acquired pneumonia cannot participate. Patients not admitted to an ICU, those who are not adults (under 18 years), and those in vulnerable populations requiring special protection are not eligible.
Trial focus: The main goal is to reduce deaths within 90 days for patients with severe pneumonia and improve outcomes for those with acute pandemic infections. The study will monitor survival rates, length of time spent in the ICU, and days free from needing a ventilator or other organ support. The trial uses an adaptive design that changes based on results as they come in, helping researchers find the best treatment options more quickly. The study is expected to continue until March 2026.
Investigational drugs: The study tests numerous medications including baricitinib, piperacillin sodium, tazobactam sodium, tocilizumab, amoxicillin sodium, clavulanic acid, azithromycin (antibiotic for bacterial infections), levofloxacin, erythromycin lactobionate, baloxavir marboxil, oseltamivir, moxifloxacin, dexamethasone, imatinib, ceftriaxone, hydrocortisone (corticosteroid that reduces inflammation), and roxithromycin. Some patients may receive a placebo for comparison purposes.
Study on Preventing Respiratory Infections and Wheezing in Late-Moderate Preterm Infants Using Bacterial Lysates
This study focuses on protecting infants born moderately-late preterm from lower respiratory infections and wheezing during their first year of life using a medication called BRONCHO-VAXOM Kinderen, which contains lyophilized bacterial lysates.
Main inclusion criteria: Babies born between 30 weeks and 35 weeks and 6 days of pregnancy can participate. They must be at least 6 weeks old after birth and have reached at least 37 weeks postmenstrual age when joining the study. Both parents or legal caregivers must give written permission for the baby to join.
Main exclusion criteria: Patients with a history of severe allergic reactions to study ingredients, those who received another investigational treatment within 30 days, patients with serious medical conditions that might interfere with the study (such as uncontrolled diabetes or heart disease), those currently in another clinical trial, patients with immune system disorders, those with recent infections requiring antibiotics, patients with chronic lung disease, those unable to follow study procedures, patients with premature birth complications unrelated to the study’s focus, or those diagnosed with conditions affecting normal breathing cannot participate.
Trial focus: The goal is to see if bacterial lysates can help reduce respiratory infections and wheezing episodes by training the immune system to fight infections better. The study will monitor the total number of physician-diagnosed lower respiratory infections and wheezing episodes in the first year of life. Researchers will also track the time to first lower respiratory episode after 12 months, virus distribution during infections, medication use, lung function, quality of life, and any serious adverse events.
Investigational drug: Bacterial Lysates are made from broken-down parts of bacteria. The therapy introduces these bacterial components safely to help train and strengthen the developing immune system of preterm infants, providing better protection against respiratory infections and reducing wheezing episodes.
Study on the Safety of Mercaptamine with Standard Therapy for Hospitalized COVID-19 Pneumonia Patients Not Requiring High Oxygen Flows
This trial is studying the safety of cysteamine when used alongside standard treatments for hospitalized COVID-19 pneumonia patients who do not require high levels of oxygen support.
Main inclusion criteria: Participants must be 18 years or older. Those who are infertile due to menopause or surgery can participate; those who can have children must have a negative pregnancy test (for women) and agree to use contraception from 2 weeks before joining until 18 weeks after receiving the study drug. Patients must have a positive COVID-19 test from a nose or throat swab, with symptoms starting 10 days ago or less. They must show signs of COVID-19 pneumonia on imaging tests (X-ray, ultrasound, or CT scan) but not need high oxygen support. Patients should be receiving low-flow oxygen support with a specific oxygen measurement (pO2/FiO2 ratio) greater than 200 mmHg. Body weight must be 50 kg or more. Patients must be able to provide informed consent and attend follow-up visits.
Main exclusion criteria: Patients currently experiencing any infectious diseases of the respiratory system like COVID-19 cannot participate if they require high levels of oxygen support. Patients outside the specified age range or part of vulnerable populations needing special protection are not eligible.
Trial focus: The study aims to evaluate the safety of cysteamine and monitor any side effects. The primary treatment phase lasts up to 10 days or until hospital discharge, whichever comes first. Blood samples will be taken at specific intervals (at start, and on days 3, 7, and 28) to measure cytokines and other blood markers. Follow-up visits will be scheduled at 28 and 90 days to assess long-term effects.
Investigational drug: Cysteamine is administered orally in the form of hard capsules. It is thought to have antiviral properties that might help fight the virus causing COVID-19. It works by reducing oxidative stress and modulating immune responses. It is classified as a mucolytic agent, which helps break down mucus in the body.
Study on OM-85 for Preventing Respiratory Infections in Children with Wheezing Illness (Ages 6 Months to 5 Years)
This study is testing OM-85, also known as Broncho-Vaxom, to see if it can prevent respiratory infections in children aged 6 months to 5 years who experience wheezing with lower respiratory illnesses.
Main inclusion criteria: Children must be between 6 months and 5 years old (in Italy, between 1 year and 5 years old). For children 1 year or older, they must have had at least 4 respiratory tract infections, including at least 2 episodes of wheezing lower respiratory illnesses in the past 12 months, with at least one requiring a hospital or doctor’s visit. For children younger than 1 year, they must have had at least 2 respiratory infections, including at least 1 wheezing episode in the past 6 months, with at least one requiring a hospital or doctor’s visit. Parents or legal representatives must provide written consent.
Main exclusion criteria: Children outside the age range, those without repeated respiratory infections with wheezing, children with other medical conditions that might interfere with the study, those taking medications that might affect results, children who participated in another trial recently, those with known allergies to the study medication, and children whose parents or guardians do not agree to follow study procedures cannot participate.
Trial focus: The study is designed as a double-blind trial lasting 12 months, where children will be randomly assigned to receive either OM-85 treatment or a placebo. Regular follow-up visits will monitor the child’s health and track the number of respiratory infections and wheezing lower respiratory illnesses experienced. The goal is to determine if OM-85 can significantly reduce these infections compared to the placebo.
Investigational drug: OM-85 (Broncho-Vaxom) is administered orally in capsule or sachet form. It is an immunostimulant that works by stimulating the immune system to enhance its response to respiratory pathogens. The study evaluates its effectiveness for both short-term and long-term treatment in reducing the frequency of respiratory infections in young children with recurrent respiratory issues.
Summary
These 7 ongoing clinical trials represent a comprehensive approach to addressing respiratory tract infections across different age groups and severity levels. A notable pattern is the concentration of trials in Italy, which hosts 5 of the 7 studies, followed by Germany with 3 trials. The largest trial spans 13 European countries, reflecting international collaboration in studying severe respiratory conditions.
Several trials focus on bacterial lysates and immunostimulants (Buccalin, OM-85, BRONCHO-VAXOM) as preventive strategies, particularly for vulnerable populations including elderly patients, young children with wheezing, and preterm infants. These studies generally aim to reduce the frequency of infections over 12-month periods by boosting immune system responses.
COVID-19 remains a significant focus, with trials testing nitric oxide nasal sprays, cysteamine, and combination drug therapies. The multi-country severe pneumonia and influenza trial stands out for its adaptive design and extensive list of investigational drugs, allowing researchers to identify effective treatments more efficiently.
Age-specific approaches are evident, with dedicated trials for preterm infants, children aged 6 months to 5 years, adults with recurrent infections, and elderly residents of healthcare facilities. This demonstrates recognition that different age groups require tailored prevention and treatment strategies for respiratory infections.
