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Clinical Trials for Pneumonia: Overview of Ongoing Research Studies

This article provides detailed information about 27 ongoing clinical trials investigating new treatments and approaches for pneumonia, including community-acquired pneumonia, hospital-acquired pneumonia, and ventilator-associated pneumonia. These studies are being conducted across multiple countries in Europe and aim to improve treatment outcomes, reduce antibiotic use, and develop new therapeutic options for patients with various forms of pneumonia.

Clinical trial locations

Study Comparing Amoxicillin and Amoxicillin/Clavulanic Acid for Treating Community-Acquired Pneumonia in Patients Aged 65 and Older

This trial, conducted in France, focuses on elderly patients aged 65 and above who are hospitalized with community-acquired pneumonia in regular hospital wards. The study compares the effectiveness of amoxicillin alone versus a combination of amoxicillin and clavulanic acid in treating this condition.

Main inclusion criteria: Participants must be 65 years or older, hospitalized for community-acquired pneumonia, and show at least two signs such as cough, sputum production, difficulty breathing, or chest pain. They must have a chest X-ray or scan showing new lung infection, and provide written informed consent in French.

Main exclusion criteria: The study excludes patients younger than 65, those not hospitalized in non-ICU wards, patients without community-acquired pneumonia, and those not receiving appropriate antimicrobial therapy.

Trial focus: The study aims to determine if amoxicillin alone is as effective as the combination treatment in achieving clinical success, defined as symptom resolution without complications over 30 days. Participants receive either amoxicillin (1 g intravenously or 500 mg orally) or amoxicillin/clavulanate (1 g/200 mg intravenously or 500 mg/62.5 mg orally) for up to five days.

Investigational drugs: Amoxicillin is a narrow-spectrum antibiotic used to fight specific bacteria, while Amoxicillin/Clavulanate combines amoxicillin with clavulanate to prevent bacterial resistance and target a wider range of bacteria. Both are given either intravenously or orally depending on the patient’s condition.

Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections

This multinational trial spanning Spain, Hungary, Greece, and Czechia investigates antibiotic treatment for children aged 9 months to under 18 years with serious gram-negative bacterial infections including complicated urinary tract infections, intra-abdominal infections, and hospital-acquired pneumonia.

Main inclusion criteria: Participants must be between 9 months and under 18 years old, have a suspected or confirmed gram-negative infection requiring hospitalization and intravenous antibiotics. Female participants who have started menstruating must have a negative pregnancy test.

Main exclusion criteria: The trial excludes children with other serious infections not related to the study, known allergies to study medications, those currently in another clinical trial, pregnant or breastfeeding participants, and those with conditions that make participation unsafe.

Trial focus: The study evaluates the combination of aztreonam-avibactam with metronidazole against the best available therapy. Participants receive intravenous infusions, with regular monitoring of liver and kidney functions, blood samples taken on Day 1 and later, and follow-up assessments to evaluate treatment effectiveness.

Investigational drugs: Aztreonam-Avibactam is a combination where Aztreonam kills bacteria by stopping their growth, while Avibactam prevents bacteria from breaking down Aztreonam. Metronidazole is added to treat complicated abdominal infections by stopping bacterial and parasite growth.

Study of Trimodulin for Adults Hospitalized with Severe Community-Acquired Pneumonia

This extensive trial operates across Belgium, Spain, Czechia, France, Austria, Germany, Romania, Hungary, and Ireland, testing Trimodulin as an additional treatment for adults with severe community-acquired pneumonia requiring intensive care.

Main inclusion criteria: Participants must be adults aged 18 years or older, hospitalized with severe pneumonia, have a C-reactive protein level of 70 mg/L or higher, show radiological evidence of active pneumonia, and require mechanical ventilation. Treatment must begin between 1 and 24 hours after starting ventilation.

Main exclusion criteria: The study excludes patients with other serious health conditions that might interfere, those outside the specified age range, pregnant or breastfeeding women, recent participants in other clinical trials, patients with allergies to study medications, and those unable to follow study procedures.

Trial focus: The study evaluates whether Trimodulin, a solution made from human proteins that help the immune system, can reduce deaths within 28 days compared to placebo when added to standard care. The treatment is administered intravenously alongside antibiotic therapy.

Investigational drugs: Trimodulin (BT588) is administered intravenously and works by modulating the immune system to help the body fight infections more effectively. It is classified as an immunomodulatory agent being studied for its potential to reduce mortality in severe pneumonia patients.

Study on Amoxicillin and Clavulanic Acid for Treating Ventilator-Associated Pneumonia in Intensive Care Patients

This French trial investigates an antimicrobial stewardship approach for ventilator-associated pneumonia in intensive care patients, comparing daily assessment-guided treatment discontinuation to conventional therapy duration.

Main inclusion criteria: Patients must be adults 18 or older with a confirmed first episode of ventilator-associated pneumonia, have received initial appropriate antibiotic therapy, and provide written informed consent. The diagnosis requires being on mechanical ventilation for more than 48 hours with specific symptoms including fever or low temperature and abnormal white blood cell counts.

Main exclusion criteria: The study excludes patients not in intensive care settings, those without ventilator-associated pneumonia, patients outside the specified age range, and those not part of the designated clinical trial groups.

Trial focus: The study explores whether daily clinical assessments to determine cure and early antibiotic discontinuation is as effective as usual treatment methods. Treatment begins within 24 hours of mechanical ventilation and involves intravenous administration of amoxicillin/clavulanic acid.

Investigational drugs: The Antimicrobial Stewardship Program being tested involves careful management of amoxicillin/clavulanic acid use through daily evaluations to determine when antibiotics can be safely discontinued, aiming to optimize treatment while preventing antibiotic resistance.

Study on AON-D21 for Patients with Severe Community-Acquired Pneumonia in Intensive Care

This trial operates in Spain, Belgium, Germany, and France, testing AON-D21, a special aptamer molecule, for patients with severe community-acquired pneumonia in intensive care units.

Main inclusion criteria: Participants must have confirmed or suspected severe community-acquired pneumonia of bacterial or viral origin, be admitted to an intensive care unit, require respiratory support, have a C-reactive protein level of at least 50 mg/L, and have a PaO2/FiO2 ratio of 300 mmHg or less. Treatment must start within 48 hours of beginning respiratory support, and participants must be between 18 and 85 years old with a body mass index between 17.5 and 40 kg/m².

Main exclusion criteria: The study excludes patients with different types of pneumonia, those not in intensive care or similar units, patients outside the specified age range, and those not meeting gender requirements.

Trial focus: The study assesses the safety and tolerability of AON-D21 when administered intravenously alongside standard care. The primary evaluation looks at how long patients need respiratory support within 28 days and monitors various health outcomes including organ support requirements.

Investigational drugs: AON-D21 is administered intravenously and is being studied for its potential to help manage severe infections by modulating the immune response and reducing inflammation. It falls under the category of immunomodulatory agents.

Study on Aspirin and Pantoprazole for Reducing Heart Attack Risk in Hospitalized Pneumonia Patients

This Dutch study examines whether adding aspirin to standard pneumonia treatment can reduce heart-related complications, specifically acute coronary syndrome, in hospitalized patients aged 40 and older.

Main inclusion criteria: Participants must be 40 years or older, have community-acquired pneumonia with clinical and radiological evidence, a CURB-65 score of 2 or higher or PSI score of 3 or higher, and be admitted to the hospital.

Main exclusion criteria: The study excludes patients with a history of myocardial infarction or current pneumonia that doesn’t meet the study criteria.

Trial focus: The study monitors patients for up to 180 days, tracking the incidence of acute coronary syndrome and other cardiovascular events. Participants receive either aspirin 80 mg daily plus pantoprazole 20 mg daily (for stomach protection) or placebo, continuing for up to 90 days.

Investigational drugs: Aspirin is being investigated for its potential to prevent cardiovascular events in pneumonia patients by inhibiting cyclooxygenase enzymes, which reduces inflammation and blood clotting. Pantoprazole is added to protect the stomach lining from aspirin’s potential side effects.

Study on Ceftriaxone Dosing for Patients with Severe Community-Acquired Pneumonia

This Belgian trial investigates optimal ceftriaxone dosing schedules for critically ill patients with severe community-acquired pneumonia, comparing every 24-hour versus every 12-hour administration based on kidney function.

Main inclusion criteria: Participants must be 18 years or older with confirmed severe community-acquired pneumonia according to IDSA/ATS guidelines, have started ceftriaxone treatment, and be planned for ICU admission. Participants must provide voluntary written informed consent and use highly effective birth control methods during the trial.

Main exclusion criteria: The study excludes patients not critically ill with severe community-acquired pneumonia, those not at risk for augmented renal clearance, patients outside specified age ranges, and those not in designated clinical trial groups.

Trial focus: The study evaluates whether adjusting ceftriaxone dosing frequency based on kidney clearance rates can improve treatment outcomes. The primary endpoint is ICU length of stay, with secondary endpoints including mortality rates and organ failure scores at various time points.

Investigational drugs: Ceftriaxone is a third-generation cephalosporin antibiotic administered intravenously at 2 grams either every 24 or 12 hours depending on the patient’s risk for augmented renal clearance. It works by interfering with bacterial cell wall formation, leading to bacterial death.

Study on Dexamethasone and Sodium Chloride for Treating Severe Hospital-Acquired Pneumonia in Critically Ill Patients with a Proinflammatory Profile

This trial operates in Belgium, Greece, France, and Spain, testing dexamethasone as an add-on treatment for critically ill patients with hospital-acquired pneumonia showing strong inflammatory responses.

Main inclusion criteria: Participants must be adults aged 18-85 years with hospital-acquired pneumonia diagnosed at least 48 hours after admission, showing severe condition with PaO2/FiO2 ratio less than 200, CRP level of 150 mg/L or higher, and receiving antibiotic treatment for less than 48 hours. Consent must be provided by a legal representative or through emergency procedure.

Main exclusion criteria: The study excludes patients without severe hospital-acquired pneumonia, those without a pro-inflammatory profile, patients outside the specified age range, and those not in designated clinical trial groups.

Trial focus: The study evaluates whether adding intravenous dexamethasone to standard care improves outcomes compared to placebo plus standard care. Treatment lasts up to five days with regular monitoring of vital signs, blood tests every 48 hours, and follow-up assessments at Day 28, Month 3, and Month 6.

Investigational drugs: Dexamethasone is a corticosteroid administered orally or intravenously that works by binding to glucocorticoid receptors to reduce inflammation and suppress the immune system. It is being studied for its anti-inflammatory and immunosuppressant properties in severe hospital-acquired pneumonia.

Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime

This Belgian and Dutch trial compares a short course of high-dose antibiotics to conventional treatment duration for critically ill ICU patients with serious infections.

Main inclusion criteria: Patients must be 18 years or older with confirmed or suspected pneumonia, intra-abdominal infection, or bloodstream infection, receiving treatment with ceftriaxone, cefotaxime, cefuroxime, piperacillin-tazobactam, or meropenem. They must be admitted to ICU, expected to stay at least two more days, and have experienced specific organ problems in the last 24 hours.

Main exclusion criteria: The study excludes patients with bacterial infections or mycoses who are not critically ill, those outside specified age ranges, patients not in designated trial groups, and those not male or female.

Trial focus: The study aims to determine if shorter, high-dose treatment is as effective as traditional longer treatment in terms of 90-day survival rates. Participants are randomly assigned to receive either short-course high-dose or conventional treatment, with close monitoring throughout.

Investigational drugs: High-dose antimicrobials are administered intravenously over a short course to treat infections. These antibiotics work by targeting essential bacterial processes like cell wall synthesis or protein production, and the study evaluates whether this approach can achieve similar outcomes while reducing antibiotic exposure.

Study on Inhaled Levofloxacin and Sodium Chloride for Patients with Community-Acquired Pneumonia, Including Those with Pre-existing Lung Disease

This Danish trial investigates whether adding inhaled levofloxacin (Quinsair) to standard treatment affects health outcomes in patients with community-acquired pneumonia, including those with pre-existing lung conditions.

Main inclusion criteria: Participants must have been admitted to hospital within the last 24 hours, show new chest X-ray evidence of pneumonia with symptoms like fever and cough, have a CURB-65 score between 3 and 5, have C-reactive protein greater than 50 or temperature above 38.0°C, be 18 years or older, and be able to provide informed consent.

Main exclusion criteria: The study excludes patients younger than 18 or older than 65, pregnant or breastfeeding women, those with severe allergic reactions to levofloxacin, severe kidney problems, history of seizures, recent participation in other trials, certain heart conditions, known resistant bacterial infections, and inability to follow study procedures.

Trial focus: The study evaluates whether inhaled levofloxacin 240 mg twice daily for three days improves or worsens health status compared to placebo. The primary assessment focuses on lung function changes one hour after first inhalation, with secondary assessments monitoring various health indicators on day 4.

Investigational drugs: Levofloxacin is a fluoroquinolone antibiotic administered through nebulization at 240 mg twice daily for three days. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication and repair.

Summary

The 27 clinical trials presented in this article represent a comprehensive research effort across Europe to improve pneumonia treatment. France leads with the highest number of trials, followed by Spain and Belgium, reflecting strong research infrastructure in these countries. The trials span multiple pneumonia types including community-acquired, hospital-acquired, and ventilator-associated pneumonia, addressing diverse patient populations from neonates to elderly patients.

Several notable patterns emerge from these studies. Multiple trials investigate immunomodulatory approaches using medications like Trimodulin, AON-D21, baricitinib, and dexamethasone, suggesting growing interest in modulating inflammatory responses rather than solely focusing on antimicrobial therapy. Antibiotic stewardship is another major theme, with several studies exploring shorter treatment durations or response-guided therapy to reduce unnecessary antibiotic exposure.

The trials also address special populations often underrepresented in research, including pediatric patients, elderly individuals, and critically ill ICU patients. Several studies specifically target drug-resistant gram-negative infections, reflecting the urgent need for new treatment approaches to combat antimicrobial resistance. The diversity of interventions being tested—from novel antibiotics and bacteriophages to immunotherapies and vaccines—demonstrates the multifaceted approach researchers are taking to improve pneumonia outcomes.

Ongoing Clinical Trials on Pneumonia

  • Study on the Effects of Oseltamivir and Drug Combination for Patients with Pneumonia

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Estonia France Italy The Netherlands Portugal +3

  • Study on Ceftriaxone Dosing for Patients with Severe Community-Acquired Pneumonia

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study Comparing Amoxicillin and Amoxicillin/Clavulanic Acid for Treating Community-Acquired Pneumonia in Patients Aged 65 and Older

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of vitamin D3 (cholecalciferol) as additional treatment for elderly patients with pneumonia or sepsis due to infection

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Reducing Antibiotic Duration for Pneumonia in Children Using Amoxicillin

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Glutathione and Sodium Chloride for Preventing Heart Injury in Pneumonia Patients

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Aspirin and Pantoprazole for Reducing Heart Attack Risk in Hospitalized Pneumonia Patients

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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