Meningococcal Infection

Researchers are conducting a prospective, multicenter observational clinical registry involving adult patients aged 18 and older with suspected acute infectious meningitis, across about 30 public and private hospitals in Brazil. The study aims to gather real-world evidence on current clinical management, treatments, and both short- and long-term outcomes to support improvements in national care protocols. It focuses on meningitis caused by viral, bacterial, or fungal infections. Clinical and laboratory data will be collected during hospitalization and through follow-up visits after discharge. The data include timing and type of empirical antibiotic therapy, time from hospital admission to first antibiotic dose, corticosteroid therapy initiation, vaccination status according to the Brazilian National Immunization Program, neurological complications, and access to specialized rehabilitation services post-discharge. The study will assess outcomes such as mortality, hospital stay length, re-hospitalization rates, and sensorineural hearing loss. Participants will be monitored closely during hospitalization and after discharge, with data collection aimed at evaluating functional status through measures like the modified Rankin Score and Barthel Index. Researchers will track serious adverse events, neurological sequelae, and rehabilitation access over a period extending up to 180 days. This comprehensive follow-up will help inform public health and clinical care improvements in Brazil.

Sepsis is a leading cause of admission to intensive care units and a major cause of respiratory failure and death in these settings. Researchers are evaluating the effectiveness of two different sepsis treatment bundles—the Hour-1 bundle versus the 3-Hour bundle—in patients admitted to emergency departments with sepsis. This study uses a pragmatic, cluster-randomized design to compare the impact of these bundles on mortality and respiratory failure outcomes, while also exploring distinct sepsis patient types to enable more personalized treatment in the future. Patients enrolled in the trial will receive the same sepsis treatment bundle, which includes measuring lactate levels, obtaining blood cultures before antibiotics, administering broad-spectrum antibiotics, providing rapid fluid resuscitation, and applying vasopressors if needed. The difference between groups lies in the timing: one group will have all interventions started within 1 hour, and the other within 3 hours of identification. The study employs a detailed electronic alert and navigation system to guide providers through the treatment steps and ensure timely completion. Participants will be closely monitored for outcomes such as mortality within 28 days, hospital length of stay, ventilator-free days, and respiratory failure incidence. The study collects routine clinical data to identify sepsis phenotypes and tracks adherence to treatment bundles. The total duration and follow-up depend on hospital stay and clinical progress, with continuous evaluation of patient data through automated screening tools and electronic health record methods.

This research aims to evaluate how using ultrasound imaging of the lumbar spinal canal affects the success of lumbar punctures in children under 18 years old. Lumbar puncture is often done to rule out infections like meningitis and encephalitis in pediatric patients. Challenges such as young age, difficulty feeling anatomical landmarks, lack of local anesthesia, practitioner experience, and patient movement can impact the procedure's success. Ultrasound before the puncture may help visualize key spinal structures and improve accuracy, especially for less experienced doctors. Participants will be randomly assigned to one of two groups: an ultrasound group or a standard group. In the ultrasound group, a bedside ultrasound exam using a Lumify linear probe will be done before the lumbar puncture to mark safe and optimal puncture sites and measure depth to the dura mater. This information is shared with the doctor performing the puncture. The standard group will undergo lumbar puncture guided only by palpation without ultrasound. Procedure time and ultrasound exam time will be recorded. Children under 18 undergoing lumbar puncture will have their procedure details recorded, including success after the first attempt and total attempts, cerebrospinal fluid quality, and duration of the procedure. Doctors will complete questionnaires about their experience. Researchers will assess how ultrasound imaging impacts lumbar puncture success, considering the doctor's experience and the child's body mass index. The study will monitor outcomes within one day after the procedure to evaluate effectiveness and safety.

Researchers are evaluating new home-based methods to measure medication and chemical concentrations in sweat and saliva compared to standard blood tests in patients with chronic or infectious diseases who are receiving medications. The study aims to see if a smart wristband can accurately monitor substances like electrolytes and metabolites in sweat, which may help in health monitoring and disease diagnosis. This pilot observational study is focused on assessing the feasibility of these wearable sweat sensors. Participants provide sweat samples using a Macroduct Sweat Collection System, saliva samples, and blood samples within 24 hours after taking their medications. They also complete short questionnaires lasting 5 to 10 minutes and allow their medical records to be reviewed. The study collects samples and data to compare the new home-based methods against the standard liquid chromatography-mass spectrometry of plasma. During the study, patients are followed periodically after completing sample collection to monitor results and assess feasibility. Researchers measure how well the home-based sampling predicts medication levels and observe plasma concentrations within 4 hours. The study includes ongoing follow-up to evaluate the ease of obtaining home-based samples and to review medical data over time.

Researchers are conducting a nationwide observational study in Denmark to track and understand infections of the central nervous system (CNS) among adults aged 18 years and older. This study systematically registers clinical characteristics and outcomes of all community-acquired CNS infections diagnosed or treated at infectious disease departments across the country since January 1, 2015. The aim is to monitor trends in infections such as bacterial meningitis, viral meningitis, encephalitis, brain abscess, neuroborreliosis, and neurosyphilis, among others. The study involves collecting detailed information on diagnosis at admission, symptoms, timing and type of diagnostic tests like lumbar puncture and cranial imaging, and treatments given. These treatments and diagnostic procedures are determined by local physicians and are not standardized across sites. The study ensures data quality through regular case reviews and annual checks of hospital records using specific diagnosis codes to identify CNS infection cases. Participants are monitored for outcomes using the Glasgow Outcome Scale at various time points depending on the infection type, such as 2 weeks for neurosyphilis and 8 weeks for brain abscess. Data on timing of hospital admission, diagnostic procedures, and antibiotic treatment are collected from hospital records. The study's main measure is the yearly incidence of CNS infections, capturing clinical course and patient outcomes to improve understanding of these serious infections over time.

Researchers are evaluating the safety and immune response of a combined vaccine that includes components for Diphtheria, Tetanus, Acellular Pertussis, Haemophilus influenzae type b, and Meningococcal group ACYW135 in children aged 2 months to 6 years. This Phase I clinical trial includes two parts: Part One uses a randomized, partially blinded, dose-escalation and partially active-controlled design, while Part Two is a randomized, blinded, placebo-controlled study focusing on 2-month-old participants. The study involves multiple vaccine dosing schedules depending on the participant's age group. Some groups receive a single dose of the combined vaccine on Day 0, while others receive three doses at 0, 2, and 4 months, followed by a booster dose between 18 and 24 months of age. The trial compares different dose levels, age groups, and also includes active comparator vaccines and placebo groups. Participants will undergo monitoring for adverse reactions within 14 days after each dose, with additional safety assessments extending up to 180 days for serious events. Researchers will evaluate immune responses by measuring specific antibodies against meningococcal groups and other vaccine components at various timepoints, including before and after booster doses. The total participation duration and detailed follow-up visits are designed to assess both safety and immunogenicity comprehensively.

Researchers are studying the best timing for steroid treatment in patients with severe infections who develop low blood pressure, known as septic shock. The study compares starting low-dose hydrocortisone early after low blood pressure develops versus waiting until standard treatments to raise blood pressure do not work. The main goal is to see which timing improves survival and other health outcomes in adults with sepsis. Participants are randomly assigned to receive either early intravenous hydrocortisone or a placebo immediately after developing low blood pressure from infection. The early hydrocortisone group receives a bolus dose followed by a continuous infusion for two days. The control group receives a matching placebo infusion. If blood pressure goals are not met after initial treatment, both groups may receive open-label hydrocortisone according to current guidelines. Blood samples are collected to measure inflammatory markers and cortisol, and blood glucose is monitored regularly. During the study, participants will receive standard care for septic shock including antibiotics and organ support. Researchers will monitor survival up to 28 days and assess secondary outcomes such as time to shock control, hospital stay length, ventilator use, kidney support, and complications like infections or high blood sugar. Safety is closely monitored, with the ability to stop the study drug if harmful effects occur. The total participation includes treatment and follow-up for up to three months after hospitalization.

This research focuses on adult patients with suspected meningitis related to cerebrospinal fluid (CSF) drainage systems, particularly those followed in the intensive care unit. It aims to evaluate the usefulness of calcitonin gene-related peptide (CGRP) and substance P levels as biomarkers for diagnosing and monitoring treatment response in post-operative meningitis, a condition that can be difficult to diagnose accurately with current methods and carries high risks of mortality and morbidity. Patients included in the study will have blood and CSF samples collected at specific times: before meningitis symptoms appear, just before the first dose of antibiotics on the first day of symptoms, and after the last antibiotic dose on the third day. These samples will be tested for CGRP and substance P levels using the ELISA method, alongside routine clinical and laboratory tests. Clinical parameters such as consciousness level, fever, sepsis status, and organ failure will also be recorded, as well as imaging results and length of ICU stay. Throughout the study, researchers will monitor various factors including patient outcomes in the ICU, survival or mortality, laboratory and radiographic findings, and infection markers. The primary outcome focuses on diagnosis over 16 months, with prognosis as a secondary outcome measure. This observational study will follow participants from initial assessment through their ICU stay to collect comprehensive data on the role of these neuropeptides in meningitis.

Researchers are evaluating the immune response and safety of a meningococcal conjugate vaccine targeting groups A, C, W-135, and Y in healthy adults aged 19 to 55 years. This phase 2/3 study aims to better understand how the vaccine triggers immunity and its safety profile when given as a single dose. The research is sponsored by EyeGene Inc. and involves comparing different doses of the investigational vaccine with an active comparator vaccine. Participants receive a single intramuscular dose of either 0.5 mL or 0.25 mL of the investigational vaccine (EG-MCV4) or 0.5 mL of the active comparator vaccine (Menveo) on Day 0. The study is randomized and double-blind, meaning neither participants nor evaluators know which vaccine is administered. The different dose groups and the active comparator help assess the vaccine's immunogenicity and safety. During the study, participants attend scheduled visits and phone calls to monitor their health and immune response. Researchers measure the primary outcome of seroresponse 28 days after vaccination to assess immunity. Safety is closely observed throughout the trial. Participants must be available for all study visits, and the total duration covers the vaccination day through the follow-up assessments leading up to the 28-day immune response evaluation.

Researchers are investigating how sex and gender differences affect immune responses to vaccines by studying transgender and cisgender individuals. This study focuses on the immune reactions to the four-component meningococcal serogroup B (4CMenB; Bexsero®) vaccine. It aims to understand how hormonal changes in transgender people, who retain their chromosomal sex but undergo gender-affirming hormone therapy, influence both humoral and cellular immune responses compared to cisgender individuals. Participants will receive two doses of the 4CMenB vaccine via intramuscular injections in the non-dominant upper arm, spaced one month apart. The study includes four groups of 30 individuals each: cisgender men, cisgender women, transgender women, and transgender men. Transgender participants must have been on stable gender-affirming hormone therapy for at least six months. The vaccination process and immune response evaluation will take place over a set period following the first dose. During the study, participants will undergo medical evaluations including medical history and physical exams to confirm general health and eligibility. Immune responses, including antibody production and T cell activity, will be measured from the first vaccination to two months after the primary vaccination. The study monitors safety and compliance, requiring participants to attend follow-up visits and adhere to study procedures. The total participation duration covers vaccination and subsequent immune response assessment over several months.