Active clinical trials for "Pneumonia"

The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety.

Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial. The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction. Secondary objectives are: To evaluate the safety of FMT. To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT. To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention. To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention. To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.

This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.

This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures

To our knowledge, there is no randomized controlled trial assessing the efficacy of mycophenolate mofetil (MMF) in the treatment of HP. We aim to perform a randomized study to assess the efficacy and safety of a regimen consisting of MMF and prednisolone against a regimen consisting of prednisolone alone for treating fibrotic HP. We hypothesize that the treatment of patients with fibrotic HP with MMF and prednisolone will be more effective and safer than treatment with prednisolone alone.

Ambroxol is a mucolytic containing an active N-desmethyl metabolite of bromhexine. It is approved by both the U.S. FDA and EMA to be marketed under several formulations including oral, nasal, oro-mucosal, rectal and intravenous formulations. One of ambroxol's authorized use is for the treatment of bronchopulmonary infections. In addition, it has been found over the decades to have other multi-pronged properties such as local anaesthesia, anti-inflammatory and anti-oxidant effects. It also stimulates surfactant production in Type II pneumocytes, thus preventing atelectasis in pneumonia. Ambroxol has demonstrated a wide safety profile and is an extensively studied drug in terms of safety with the commonest side effects being skin rashes, allergies, nausea, vomiting, abdominal pain and dyspepsia. Severe pneumonia is is defined by the American Thoracic Society (ATS) as pneumonia that requires ICU admission and specifically fulfils one of two major criteria, or three out of nine minor criteria as per recommended in the latest ATS guideline. This study aims to investigate the effects of using intravenous ambroxol as an adjunct therapy on the resolution of severe pneumonia. The improvements in modified Clinical Pulmonary Infection Score (CPIS) will be used as a surrogate for resolution of severe pneumonia. Modified CPIS is a clinical score of 0-12 based on 6 clinical features: volume and character of tracheal secretions, chest radiograph infiltrates, body temperature, leukocyte count, oxygenation index, and microbiology results. Traditionally, CPIS score has been used to facilitate the diagnosis of VAP where a cut-off point of >6 is used to denote possible pneumonia. Interestingly, Luna et al has found that serial improvements in CPIS score can be successfully used as a surrogate for pneumonia resolution with good correlation with eventual survivability. This study will also explore the effects of using ambroxol on other clinical outcomes of patients with severe pneumonia, including ICU mortality, duration of ICU stay, length of mechanical ventilation and incidence of reintubation within 48 hours. If this adjunct treatment is able to reduce duration of ICU stay and length of MV, it will not only directly impact the patients' short & long term outcomes but will also confer logistical benefits in terms of saving resources and reducing healthcare economic burden while optimizing ICU turnover rates.

Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury, that can be isolated or associated to myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay. The aim of this clinical trial is to examine whether in-hospital treatment with iv methylprednisolone (20 mg b.i.d) may reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin) and eventually cardiovascular events during a short- and long-term follow-up in patients hospitalized CAP.

CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria. Five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician. The primary outcome is 90-day readmission-free survival which will be tested with a non-inferiority margin of 6%.

There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.