Bacterial Infection

This research aims to improve the diagnosis of urinary tract infections (UTI) in older adults aged 65 years and above. It focuses on finding the best cut-off values for individual urine biomarkers such as NGAL, IL-6, AZU, TIMP2, and CXCL9, along with assessing the sensitivity, specificity, and predictive values of these markers. The study also seeks to validate urine leukocyte count cut-offs and evaluate the combination of biomarkers for better diagnosis. Additionally, it will explore how biomarker levels relate to symptom duration, complications, recurrence within two months, and hospital stay length. The performance of the astrego PA100 device in detecting bacteriuria will also be validated. Participants will provide a midstream urine sample once at the start of the study, which will be collected in a sterile container for biomarker testing. They will answer questions about their symptoms and general health at the beginning and again after eight weeks. Vital signs, including temperature and blood pressure, will be measured once at the start. This observational study does not involve any treatment but focuses on diagnostic assessments. During the study, participants will be monitored for symptoms and potential complications. Researchers will track symptom duration, hospital stay lengths, and recurrence of UTI over an eight-week period. Diagnostic accuracy of individual biomarkers and their combinations will be evaluated at baseline. The study will also assess the diagnostic performance of the PA100 device for bacteriuria detection. Overall participation involves two assessments and one urine sample collection, spanning about eight weeks from inclusion to follow-up.

Researchers are evaluating a radioactive tracer called [18F]fluoropropyl-trimethoprim ([18F]F-TMP), an imaging drug injected to detect active bacterial infections in the body using Positron Emission Tomography/Computed Tomography (PET/CT). This Phase 1 study aims to understand how this tracer distributes and moves through the body in human patients with known or suspected bacterial infections. The tracer is based on trimethoprim, a widely used antibiotic, and is studied here for its imaging potential rather than treatment. Participants will join one of two study groups: the Biodistribution cohort or the Dynamic cohort. The Biodistribution group, including up to 5 patients, will undergo several PET/CT scans from head to mid-thigh or feet over about 4 hours to observe tracer distribution. The Dynamic group, with up to 15 patients, will have approximately 60 minutes of dynamic scanning followed by up to two static scans after injection of [18F]F-TMP. These scans help researchers analyze tracer uptake and movement in the body over time. During the study, participants will have PET/CT imaging sessions to monitor the tracer's uptake in infected and non-infected tissues. Researchers will measure the tracer's biodistribution and kinetics, including changes after therapy. Safety monitoring includes assessments for any inability to tolerate imaging and pregnancy testing for women of childbearing potential. The study duration for outcome measures is approximately 3 years, with no mention of long-term treatment or follow-up beyond imaging evaluations.

Researchers are studying patients with severe pneumonia admitted to the Respiratory Intensive Care Unit (RICU) to understand the epidemiology and clinical characteristics of pneumonia caused by various factors. This observational cohort study aims to gather detailed clinical data including morbidity, mortality, risk factors, symptoms, and radiographic changes to help improve clinical care for severe pneumonia patients. The study involves patients admitted to the RICU due to pneumonia from any cause. There are no specific treatments or interventions being tested, as this is an observational study collecting data during the patients' stay. Researchers will observe respiratory support parameters, treatment options, and symptom developments during the initial days and weeks of hospitalization. Participants will be monitored for outcomes such as mortality and morbidity during their time in the RICU, with measurements taken over one year. Data on symptoms within the first 48 hours, respiratory support during the first 5 days, and treatments over 3 weeks will be collected. The study records clinical information to better understand pneumonia in this critical care setting, with participant involvement lasting as long as their hospital stay and follow-up for outcomes.

Researchers are conducting a phase 2a, multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial to study patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). The study aims to identify safe and well-tolerated doses and assess the pharmacokinetics (PK) of the drug OMN6 in these patients. This research evaluates how OMN6 behaves in the body and its safety when added to standard therapy. Participants will be randomly assigned to one of two groups: one receiving OMN6 along with standard antimicrobial treatment using meropenem and colistin, and the other receiving a placebo combined with the same standard treatments. OMN6 is given as three intravenous infusions of either 50 mg, 100 mg, or 150 mg each, administered over three hours, all delivered on a single day. The background treatment with meropenem and colistin continues for 7 to 14 days. The study compares safety and PK profiles between these groups. During the trial, participants will be monitored for safety over 28 days following treatment. Pharmacokinetic measurements like the maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC), and half-life (t1/2) of OMN6 will be assessed within one day of dosing. Safety evaluations include observing adverse events and other clinical parameters. This thorough monitoring will help researchers understand OMN6's safety and behavior in patients with HABP or VABP caused by ABC, with the study expected to continue until March 2027.

Researchers are evaluating the safety and effectiveness of a single intravenous dose of agenT-797 combined with standard of care (SOC) compared to placebo plus SOC in adults with severe pneumonia and moderate to severe acute hypoxemic respiratory failure (AHRF). The study aims to reduce short-term mortality in this patient group and is conducted in two parts: an initial Run-in Phase and a Phase 2 randomized, double-blinded phase. All participants receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS). In the Run-in Phase, participants receive open-label agenT-797 plus SOC to help characterize the baseline population. After this phase, participants are randomized to one of two groups in Phase 2: agenT-797 plus SOC or placebo plus SOC. Both treatments are given as intravenous infusions, and SOC includes antimicrobial therapy and corticosteroids following guidelines. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, days without oxygen support or ventilator use, time to resolution of hypoxemia, ICU-free days, infections, antibiotic-free days, and time to hospital discharge. Additional measurements include mortality at Day 90 and changes in cytokine profiles at baseline and on Days 3, 7, and 14. The study includes safety monitoring and assessments throughout the trial period, which is expected to end in August 2027.

Researchers are evaluating the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy individuals aged 2 years and older. This phase 3 clinical trial is randomized, blinded, and parallel controlled to compare the immune response and safety profile of the study vaccine against a control vaccine. The study focuses on measuring antibody responses and monitoring adverse reactions following vaccination. Participants will receive a single dose of either the 23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm or a control pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp. The study is designed with two groups, and both vaccines are administered as one dose. The trial includes detailed safety monitoring periods immediately after vaccination and over several months to assess adverse events. During the study, participants will undergo evaluations of their antibody levels against 23 pneumococcal serotypes 30 days after vaccination, with follow-up measurements at 3 and 6 years. Researchers will also track the incidence of adverse reactions within 30 minutes, 7 days, 30 days, and serious adverse events up to 6 months after vaccination. The total duration of participation includes initial vaccination and long-term follow-up for safety and immune response assessment.

Researchers are evaluating whether combining ceftazidime (with or without avibactam) and fosfomycin leads to better clinical outcomes compared to ceftazidime alone in adults hospitalized with suspected severe Gram-negative bacterial infections. This phase 3 clinical trial aims to see if adding fosfomycin shortens the time to recovery as measured by normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and a significant drop in C-reactive protein (CRP), a marker of inflammation. The study also monitors the safety of this combination treatment. Participants will be randomly assigned to one of two groups. The intervention group receives intravenous ceftazidime with or without avibactam plus fosfomycin, while the control group receives ceftazidime with or without avibactam plus a placebo infusion. Treatment is given for about three days, typically three times daily, with adjustments based on kidney function. The addition of avibactam depends on the presence of resistant bacteria as determined by the physician. Fosfomycin or placebo is given alongside in matching schedules. During the study, participants will provide extra blood samples to measure CRP levels and will be monitored in hospital or contacted by phone after discharge up to day 28 for follow-up questions. Researchers measure the time from treatment start until qSOFA parameters normalize and CRP levels decrease by half. Safety is closely watched by tracking adverse events during treatment and shortly afterward. The total participation spans the initial treatment and follow-up period to assess recovery and tolerability.

This research aims to evaluate and compare the ability of two blood test ratios, the Neutrophil/Lymphocyte ratio (NLR) and the Lactate/Albumin ratio (L/A ratio), to predict outcomes in patients with sepsis and septic shock caused by lower respiratory tract infections. Sepsis is a serious condition where the body's response to infection causes organ dysfunction and can be life-threatening, especially in intensive care settings. The study focuses on understanding which ratio better predicts patient prognosis and mortality. Participants admitted to the intensive care unit with sepsis related to lower respiratory infections will undergo clinical assessments and laboratory tests. Data collected include demographics, vital signs, medication use, mental status, and organ function scores. Blood tests will measure neutrophils, lymphocytes, serum albumin, lactate, and other markers. Various body fluid cultures will be taken to identify infection sources. All tests are performed at a central lab. During the study, researchers will track patient outcomes such as mortality, length of ICU stay, use of vasoactive medications, and support therapies like mechanical ventilation or renal replacement. The main outcomes are mortality and the prognostic value of the two blood test ratios measured from ICU admission until discharge or death. The study will last 12 to 18 months, with careful monitoring to understand how these ratios relate to patient survival and recovery.

Researchers are evaluating the effectiveness of four different treatment plans for Helicobacter pylori infection in Chinese children aged 6 to 18 years. This study aims to identify which regimen is best by comparing triple therapy, sequential therapy, bismuth quadruple therapy, and concomitant therapy. The study also investigates bacterial resistance, gene factors, and changes in gut microbiota to help develop new guidelines for treating this infection in children. Participants are randomly assigned to one of four groups receiving either triple therapy, sequential therapy, bismuth quadruple therapy, or concomitant therapy over a 14-day period. Each treatment group uses specific combinations of medications, including combinations of Omeprazole, Amoxicillin, Clarithromycin, Metronidazole, and Colloidal Bismuth Subcitrate. The study measures Helicobacter pylori eradication rates 4 to 6 weeks after treatment completion. Children in the study undergo tests including a 13C-urea breath test to confirm infection clearance. Researchers also assess side effects at 2 and 4 to 6 weeks after treatment, monitor changes in gut microbiome diversity at multiple time points, and analyze genes related to drug metabolism and bacterial virulence before therapy. Patient medication compliance is checked two weeks after treatment. The trial continues until the end of 2025, with detailed monitoring of treatment impact and safety.

This research aims to compare how well two diagnostic methods—percutaneous aspiration and open biopsy—detect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection (PJI) is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.