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An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) That are Refractory to Treatment

Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…

Tidal ventilation distribution and patient-ventilator synchrony during Proportional Assist Ventilation with load-adjustable gain factors

To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.

A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC (50/500 mcg b.i.d.) in patients with moderate to severe COPD

The purpose of this study is to determine whether the efficacy and safetyof QVA149 (110/50 *g o.d.) and triple treatment with tiotropium (18 *go.d.) + salmeterol/fluticasone propionate FDC (50/500 *g b.i.d.) arecomparable in patients with moderate…

Point-of-Care C-reactive protein to assist in primary care management of children with lower respiratory tract infection

Analyse costs and effects of point of care (POC) C-reactive protein (CRP) measurement in children with non-severe lower respiratory tract infection (LRTI) in primary care.

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…

Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

Relation between biomarkers and new radiographic abnormalities in patients hospitalized with Community Acquired Pneumonia

1. To assess the incidence of pulmonary infiltrates by means of low dose CT-scan in patients with a high clinical suspicion of CAP but with a normal chest x-ray 2. The levels of biomarkers (CRP, PCT, White blood cell count) will be compared to the…

Advanced understanding of Staphylococcus aureus and Pseudomonas aeruginosa Infections in EuRopE * Intensive Care Units (ICU)

To estimate the incidence of S. aureus and P. aeruginosa ICU pneumonia, especially VAP, and to assess its association with patient-related and contextual factors, e.g. colonization status, serum antibody levels against S. aureus alpha toxin [AT],…

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 (…

A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…

Fluids in mechanically ventilated children with acute infectious lung disease: how dry should they be?

This research project aims to determine the feasibility of setting up a randomized controlled trial to study the effects of different fluid management protocols on the outcome of mechanically ventilated pediatric patients with acute infectious lung…

Microbiological etiology of community acquired pneumonia in immunocompromised adults.

Objective of the study is to quantify the microbiological etiology in immunocompromised patients, at least 18 years of age, with CAP needing hospitalization. And to determine the severity, antibiotic use and outcome of CAP in immunocompromised…

Observational multi-center, prospective study to develop a novel multi-parametric diagnostic model for hospitalized patients and patients on the Emergency Department presenting with lower respiratory tract infections and/ or sepsis.

To develop a novel multi-parametric diagnostic model for the management of patients with LRTI and/or sepsis that will be based on novel pathogen- and host-related factors.

Dexamethasone in community-acquired pneumonia.

Primary Objective: - To confirm the effect of dexamethasone on clinical outcome in patients admitted with CAP.Secondary Objectives: - To study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis…

CRP-POCT in suspected airway infected patients in the long-term care facility

The main objective is to investigate the additional value of CRP-POCT (C-reactive protein point-of-care-test) testing in patients suspected of airway infections in long-term care facilities.

MOSAIC-2 Study: MOdel to Study upper Airway Immunity upon Cholera vaccination

To investigate whether raw milk, pasteurized milk or ultra-heat treated (UHT) milk is able to enhance the systemic immune response as induced by oral cholera vaccination, in comparison to regular vaccination. Oral vaccination can also induce an…

A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is as follows:* To evaluate the effect of presatovir (GS-5806) on nasal RSV viral load in RSV positive LT recipients with acute respiratory symptomsThe secondary objectives of this study are as follows: * To…

Clinical value of ultra-low dose computed tomography compared to chest X-ray investigations in diagnosing pulmonary pathology

1. To assess the clinical value of ULDCT as compared to CXR examinations for diagnosing pulmonary pathology.2. To identify patient groups or indications that may benefit by replacing CXR by ULDCT examination. 3. To analyze the effect of…

The use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams

Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.

An exploratory study to assess the RSV titer in healthy volunteers as guidance for the main study

To determine pre-existing virus neutralization titer levels against RSV in a general healthy population (immunogenicity is a secondary study objective (proof-of concept) in the main phase I study).