Otitis (Ear Infection)

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drugs safety profile. Participants will be divided into two main groups single ascending dose SAD and multiple ascending dose MAD cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are investigating the use of Clemastine Fumarate combined with engineered sound to treat age-related central auditory processing disorder CAPD, a condition affecting many people over 40 and causing difficulty hearing in noisy environments. This trial aims to test if the therapy, called Localized Oligodendrocyte Optimization Therapy LOOT, which showed promise in animal studies, can improve hearing in noise for humans. The study is designed to compare the effectiveness of the drug with or without engineered sound in a controlled, randomized setting. Participants will be randomly assigned to one of four groups Clemastine Fumarate with engineered sound, Clemastine Fumarate with placebo sound white or pink noise, placebo drug with engineered sound, or placebo drug with placebo sound. The drug dosage is carefully controlled and given orally over 30 days, while participants listen to the assigned sound stimulation through headphones for one hour daily. The trial includes an adaptive design allowing adjustment of study arms based on interim results. Throughout the study, participants will undergo hearing tests to measure their ability to hear in noisy environments, both before and after treatment. Additional assessments include questionnaires on speech and tinnitus, auditory brainstem response tests, physical exams, blood tests, and EKGs to monitor health and safety. The treatment period lasts one month, with evaluations scheduled around weeks five or six. Safety and hearing improvements are carefully monitored to assess the therapys impact.

Researchers are developing an artificial intelligence AI system to identify key anatomical landmarks during otolaryngological surgeries, such as mastoidectomy and other procedures involving the temporal bone. The goal is to enable real-time tracking of critical structures like the incus and lateral semicircular canal to help surgeons avoid damaging important areas during operations. This observational study focuses on improving surgical safety and precision by using AI technology. The AI system uses annotated data points from surgical videos to recognize and segment the incus, lateral semicircular canal, facial nerve, and facial nerve recess based on their positions relative to surrounding tissues. The model enhances images with contrast adjustment and localized magnification, then classifies and locates these structures continuously during surgery. It also applies statistical analysis to predict the facial recesss location to provide useful guidance for surgeons and improves accuracy through ongoing training. Participants undergoing otolaryngological surgeries with microscope exposure of the temporal bone will have their surgeries recorded and analyzed. The study collects high-resolution temporal bone CT scans and surgical video data to assess the AI models accuracy. Researchers will monitor relevant indicators of the AI models performance throughout the study period, as well as during the week from hospital admission to discharge. This study will help evaluate how well AI can assist in identifying important surgical landmarks in real time.

Researchers are conducting an international observational study to understand acute infectious diseases in adults hospitalized with suspected or confirmed infections. This study aims to collect data and biospecimens from patients worldwide to characterize respiratory and non-respiratory infections, established infectious diseases, and emerging infectious diseases. The information gathered will help identify risk factors, clinical features, and management strategies, and guide future clinical trials. Participants in this study are adults admitted to a hospital with an acute infection or suspected infection. There is no intervention or treatment given as part of the study since it is observational. The study focuses on collecting clinical data and biospecimens during hospitalization to better understand the disease processes and outcomes. During the study, participants will be monitored for clinical outcomes such as mortality at 28 days, time to recovery, clinical improvement, organ support requirements, and organ failure scores. Data collection includes clinical assessments and biospecimen sampling. The study will continue until June 2027, with participants followed for outcomes mainly up to 28 days after enrollment. This observational approach supports the development of future clinical trials by providing detailed insights into acute infections.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are evaluating the safety and effectiveness of stopping antibiotic treatment early in adults hospitalized with respiratory viral infections. This study focuses on patients with moderately severe disease who test positive for respiratory viruses such as influenza, respiratory syncytial virus, parainfluenza virus, or human metapneumovirus. The goal is to determine if early discontinuation of antibiotics leads to similar clinical outcomes compared to continuing antibiotic therapy, aiming to reduce unnecessary antibiotic use and combat antimicrobial resistance. Participants are randomly assigned to either stop antibiotic therapy as started by their admitting physician or to continue antibiotic therapy without changes. The study monitors early clinical response at 120 hours after randomization, defined by survival with symptom improvement and no need for rescue antibiotics. Secondary assessments include mortality rates, hospital stay duration, antibiotic use, and readmission rates, all measured during hospital admission and up to 30 days after discharge. During the trial, participants undergo nasopharyngeal swab testing to confirm viral infection and are monitored closely for symptoms, survival, and antibiotic use. Researchers evaluate clinical response at 120 hours and track outcomes such as mortality, hospital stay length, and antibiotic doses until discharge and 30 days later. The study aims to gather detailed safety and efficacy data over the hospital stay and follow-up period, supporting more targeted antibiotic use in viral respiratory infections.

Delirium is a sudden state of confusion commonly seen in older adults admitted to hospitals, and identifying its cause quickly is important but often difficult. Infection may cause delirium, and many patients have bacteria in their urine, but bacteria alone do not always indicate a true infection. This trial studies whether antibiotics help treat delirium in adults aged 60 and older who have delirium and suspected urinary infection but no clear signs of urinary tract infection. Participants will be randomly assigned to one of two groups one group will start or continue taking antibiotics prescribed by their main doctor, with the antibiotic type and treatment length decided by the doctor. The other group will not receive antibiotics. This randomized controlled trial compares these approaches to see if antibiotics improve delirium in this population. During the study, researchers will assess delirium at day 7 or when participants leave the hospital, whichever comes first. They will also monitor other outcomes like hospital stay length, blood infections, ICU transfers, falls, use of restraints or antipsychotics, antibiotic days, and infections such as C. difficile up to 30 days. Deaths and hospital readmissions will be tracked for up to one year. The study aims to provide clearer guidance on antibiotic use for delirium with suspected infection in older adults.

Researchers are investigating auditory functions in patients with Multiple Sclerosis MS by using various hearing tests and analyzing cerebrospinal fluid CSF for inflammatory markers. This observational case-control study compares healthy adults and adults with Relapsing Remitting MS, aiming to find correlations between auditory test results and CSF findings to better understand hearing issues related to MS. Participants will undergo several auditory tests including Pure Tone Auditory test, Tympanometry, Stapedial Reflex, Speech Perception test, and if applicable, tinnitus-related questionnaires and acuphenometry. Additionally, Distortion Product Otoacoustic Emissions DPOAEs and Auditory Brain Response ABR tests will be performed. CSF will be collected via lumbar puncture for analysis. MRI tractography is performed if hearing impairment is detected. Participants involvement includes screening through medical records, MRI scans, blood tests, and hearing loss questionnaires. They will undergo the auditory tests and CSF sampling as described. Researchers will measure auditory function and its correlation with CSF results over 12 months. The study includes healthy volunteers and MS patients aged 20 to 40 years, with ongoing monitoring of auditory function and neurological status.

Researchers are studying children who experience spontaneous perforation of the tympanic membrane SPTM, a condition where the eardrum tears and causes ear discharge otorrhea. This study aims to understand the bacterial causes of this condition several years after the introduction of the pneumococcal conjugate vaccine PCV13 in 2010. Although the number of acute otitis media AOM cases has decreased since the vaccine, SPTM still occurs in some children and needs further investigation. Children with SPTM are enrolled by pediatricians across France and a sample of middle ear fluid is collected using a cotton-tipped wire swab from the spontaneous ear discharge. This fluid is then transported to specialized microbiology labs for bacterial analysis. The study captures cases where otorrhea appears as the first sign of AOM or after treatment failure or recurrence of AOM symptoms. Participants undergo sample collection during their inclusion visit, and researchers analyze the microbiological profiles of the ear discharge. They also study patient characteristics, clinical features of treatment failure or recurrence, and compare rapid diagnostic test results with laboratory findings. The study involves children aged 3 months to 15 years and continues until October 2028, aiming to improve understanding of ear infections in children.