View clinical trials related to Bacterial Pneumonia.
Filter by:CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunct therapy with standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in healthy volunteers followed by a similar assessment in patients with suspected or confirmed community acquired bacterial pneumonia of moderate severity. The main questions the study aims to answer are: - Are single ascending doses of a CMTX-101 intravenous (IV) infusion safe and tolerated - What is the pharmacokinetic (PK) profile of single-ascending doses CMTX 101 - Do single ascending doses of CMTX 101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs) Exploratory efficacy biomarkers will also be measured in the patient part of the study. Participants will be administered a single IV infusion of CMTX-101 over a 60-minute period; patients will receive the infusion after starting standard of care antibiotics.
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.
The pandemic triggered by the new SARS-CoV-2 presents the German health system with previously unknown challenges. There are currently no effective therapies for the treatment of the SARS-CoV-2 lung disease Covid-19. The aim of the joint project PROVID is to draw conclusions from the often very different clinical appearance of infections with the SARS-CoV-2 pathogen in order to improve patient care through targeted clinical management. The effects of infections with the SARS-CoV-2 pathogen are wide-ranging and include a spectrum from symptomlessness to infections of the upper respiratory tract, uncomplicated but also severe pneumonia with lung failure and high mortality. PROVID will first check whether certain host factors determine the severity and / or the course of Covid-19. Research is also being carried out into whether the molecular and clinical values of Covid-19 patients differ from those of patients with pneumonia caused by other pathogens. In addition, it will be tested whether specific molecular markers describe the severity of the disease and are suitable as an aid for targeted therapy for Covid-19. PROVID is an interdisciplinary joint project made up of three sub-projects that are being implemented at three locations (Charitè-Universitätsmedizin Berlin, Universität Leipzig IMISE and CAPNETZ STIFTUNG / Hannover). PROVID is based on three clinical research platforms with a high track record in recruiting patients with high-quality data and biomaterials on the one hand and guideline-changing results on the other hand: CAPNETZ (competence network CAP, since 2002, world's largest database and biobank for CAP), PROGRESS (Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis, since 2007) and CAPSyS (systems medicine of community-acquired pneumonia, since 2014). The COVID-19 patients are recruited into 3 different patient cohorts via these 3 research platforms. 1. PROVID-CAPNETZ, 2. PROVID-PROGRESS, 3. PROVID-CAPSyS.
Background: In thoracic surgery, postoperative pneumonia (POP) is the leading cause of postoperative morbidity and mortality. The clinical diagnosis of POP is difficult and conventional microbiological diagnostic tests perform poorly. The contribution of molecular diagnostic tests (multiplex PCR, mPCR) should be evaluated to optimize the diagnostic and therapeutic management of POP. Objectives: The main objective is to describe the microbiological relationship between the existence of pre- (if available) and intra-operative bronchial and pulmonary bacterial colonization and the occurrence of POP. The secondary objectives are to analyze the contribution of the mPCR for the diagnosis of POP and to validate the predictive factors of POP described in the literature Material and methods: A monocentric prospective non-interventional research with minimal risks and constraints. The study population is represented by all the consecutive adult patients hospitalized for lung surgical resection (except surgical resection indicated for infectious disease) during one year. The preoperative respiratory samples within the 3 preceding months (date and type, pathogen and threshold) are recorded, if available. Intra-operative bronchial aspirate is performed for direct examination and culture (pathogen and threshold) and mPCR (PCR1). A mPCR is optionally performed on the surgical specimen (PCR2). In case of postoperative clinical suspicion of POP, invasive or non invasive samples of respiratory tract secretions are obtained for direct examination and culture (pathogen, threshold) and mPCR (PCR3). A clinical pulmonary infection score (CPIS) is calculated by integrating the results of conventional tests (CPIS1) and mPCR (CPIS2). The pre / intra operative and postoperative microbiological relationship will be described qualitatively and quantitatively and analyzed using correlation tests. Concordances and discrepancies between conventional tests and mPCR will be studied to analyze the contribution of molecular tests in this context.