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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia

The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…

GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One

The aim is to understand which individuals benefit from antibiotics.

Monitoring of influenza-like symptoms among elderly, an observational study

Primary Objective: • To determine the incidence rate of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To explore the effect of 13vPnC on the incidence of self-…

Bronchiectasis and long term Azithromycin (AZM) Treatment:
a randomised placebo-controlled trial studying disease modifying effects of immunomodulating treatment

Primary objectives1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?Secondary objectives1. Is…

Self-reported influenza-like symptoms among elderly

Primary Objective: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To determine the incidence…

A phase III, randomized, double-blind, double-dummy, placebo-controlled, multicenter, 3-period incomplete block, multidose crossover study to determine the effect on lung function of indacaterol (150 and 300 mcg o.d.) in patients with moderate to severe COPD, using tiotropium (18 mcg o.d.) as an active control

The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.

Stress ulcer prophylaxis with proton pump inhibitor (pantoprazole) in adult critically ill patients in the intensive care unit: A randomized, blinded, placebocontrolled trial

To assess the benefits and harms of SUP with PPI in adult, critically ill patients in the ICU.

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment

To determine the effect of benralizumab on the rate of asthma exacerbationsSubstudy: - To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen whilemaintaining asthma control.- To assess…

Randomized,double-blind,placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the improvement of coughing and quality of life in subjects with bronchiectasis.

Since coughing is the major symptom in BE, the objective of this trial is to evaluate the clinical efficacy of ICS/LABA treatment in subjects with BE on coughing. The primary outcome variables of interest is the Leicester cough questionnaire (LCQ),…

A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.

Primary Objective-To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with idiopathic pulmonary fibrosis (IPF) as evaluated by the rate of decline of forced vital capacity (FVC)…

Convalescent Plasma Therapy from Recovered Patients to Treat COVID-19 Early in SARS-CoV-2 Disease

Primary objectivesTo evaluate the efficacy, feasibility, viro-immunological kinetics and safety following the administration of ConvP as a therapy for outpatients diagnosed with COVID-19 at increased risk for an unfavourable clinical outcome and…

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia. Specific…

ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19

To evaluate the efficacy of BEM compared with placebo in reducing all cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care.

Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates.

This study has been transitioned to CTIS with ID 2024-518498-32-01 check the CTIS register for the current data. The project*s overarching aim is to diminish respiratory disease burden in moderate-late preterm born infants in their first year of…