A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity...
Community-acquired PneumoniaBacterial PneumoniaCMTX-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.
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best...
Complicated Urinary Tract InfectionAcute Pyelonephritis3 moreThis study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the treatment of patients with cUTI, AP, HABP, VABP, and cIAI, due to Carbapenem Resistant Enterobacterales.
Sphingosine-1-phosphate and Pneumonia
PneumoniaBacterialPneumonia is a major infectious cause of death worldwide and imposes a considerable burden on healthcare resources. Sphingosine-1-phosphate (S1P) is a bioactive sphingolipid and involved in many physiological processes including immune responses and endothelial barrier integrity. In term of endothelial barrier integrity, S1P plays a crucial role in protecting lungs from pulmonary leak and lung injury. Because of the involvement in lung injury, S1P could be the potential biomarker of pneumonia. Recently, our pilot study suggested that patients with CAP have significantly higher plasma S1P levels than healthy individuals. Interestingly, our observational study also showed significantly elevated S1P level in the patients who were treated with methylprednisolone during the hospitalization. Based on the above evidence, we hypothesize that S1P plays an important role in the pathobiology of pneumonia. Moreover, S1P is not only a useful biomarker for diagnosis of CAP, but also can be an indicator for using corticosteroids adjuvant therapy.
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized...
Gram-negative Bacterial InfectionsHospital Acquired Bacterial Pneumonia (HABP)2 moreThe primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired...
PneumoniaBacterialThis 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
Pediatric Helmet CPAP Pilot Study
BronchiolitisViral4 moreThis a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.
Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
Community-acquired PneumoniaBacterial PneumoniaThe purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants...
Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial PneumoniaThis study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality.
Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Patients With Hospital-acquired...
PneumoniaVentilator-Associated2 moreVAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.
Imipenem/Cilastatin/Relebactam Pharmacokinetics, Safety, and Outcomes in Adults and Adolescents...
Cystic FibrosisPneumonia1 moreThere is established evidence that patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Imipenem/cilastatin/relebactam is a novel broad spectrum intravenous beta-lactam/beta-lactamase inhibitor combination antibiotic with potent activity against multidrug resistant Gram-negative bacteria, including imipenem non-susceptible Pseudomonas aeruginosa. Relebactam has also been shown to restore imipenem activity in Burkholderia cepacia complex, a group of opportunistic multidrug resistant pathogens that commonly infect patients with CF. This study will determine the pharmacokinetics and tolerability of imipenem/cilastatin/relebactam in 16 adolescent and adult patients with CF acute pulmonary exacerbations at one of seven participating hospitals in the US, with exploratory aim of reporting relative percent increase in FEV1 from pre- to post-treatment and return to baseline FEV1 after treatment with imipenem/cilastatin/relebactam for acute pulmonary exacerbations due to P. aeruginosa in patients with CF. Patients will receive a 10-14 day course of imipenem/cilastatin/relebactam, dosed according to renal function every 6 hours over 30 mins, with or without adjunctive aminoglycoside or fluoroquinolone therapy per local hospital guidelines. Blood will be sampled during one dosing interval at steady-state (i.e. after at least 3 doses) to determine concentrations and pharmacokinetics of imipenem and relebactam. Relative change in pulmonary function will be assessed two weeks after end of therapy. Safety and tolerability will be assessed throughout the duration of the study.