Tinea Infection (Ringworm, Athlete's Foot)

Researchers are evaluating the safety, tolerability, and pharmacokinetics of ATB1651, a topical solution, in adults with mild to moderate onychomycosis, a fungal infection of the toenails. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess how well ATB1651 works and how safe it is when applied to the great toenail. The study plans to enroll up to 120 participants divided into multiple sequential cohorts, with an optional fourth cohort, to test different dosing regimens and strengths of the drug. Participants will be assigned to receive either ATB1651 or a placebo in a ratio of 51 within each cohort. Cohorts 1 to 3 will receive a 3% ATB1651 solution applied once or twice daily for 12 to 20 weeks, followed by a follow-up period lasting 16 to 24 weeks. An optional Cohort 4 may receive a 5% ATB1651 solution once daily for 12 weeks with a 24-week follow-up. Dosing in later cohorts depends on safety reviews from earlier groups. During the study, participants will visit regularly for safety assessments, blood tests to measure drug levels, and evaluations of their toenail condition. Researchers will track the complete cure rate of onychomycosis over up to 252 days and monitor for any side effects. The study will also measure various pharmacokinetic parameters such as maximum plasma concentration and elimination rates. Participant involvement includes applying the treatment daily and attending follow-up visits to assess long-term outcomes and safety.

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 a new artificial intelligence AI tool designed to assist primary care providers in assessing skin conditions. This AI-powered dermatology image reference app works with a smartphone to provide reference images, helping providers make diagnoses using their medical training. The study aims to compare diagnoses made by primary care providers using the AI tool to those of a panel of dermatologists, considered the gold standard. The research is supported by the Advanced Research Projects Agency for Health ARPA-H and focuses on improving diagnostic accuracy and care in real-world clinical settings. The study involves primary care providers using the Belle AI tool, which analyzes images captured via a smartphone app and identifies over 2,000 skin conditions based on a large image database. Providers use the app during patient visits to capture images and receive differential diagnoses, which they review before making final decisions. After the initial visit, participants receive notifications to submit follow-up images using the app over a two-week period. Providers reassess diagnoses based on updated AI analysis, and follow-up visits may be scheduled or canceled depending on results. Providers receive training on the app and give feedback through surveys. Participants present with a primary dermatological complaint and consent to study procedures, including using the smartphone app to submit images. Researchers monitor diagnosis accuracy compared to a dermatology review committee consensus and assess economic impact and provider experience. The study lasts about 14 days per participant, with ongoing documentation in electronic medical records and continuous case review to determine care needs or resolution.

Researchers are evaluating the efficacy and safety of two products for treating onychomycosis, a fungal nail infection, in a multicenter, randomized, evaluator-blinded clinical study involving 88 patients. The study compares a test medical device called ENRICHED X92001591 with a reference drug product, Loceryl 5% amorolfine. The main goal is to measure the increase in the percentage of healthy nail surface compared to the baseline, assessed by a blinded investigator. Participants will use either the ENRICHED device twice daily or Loceryl once weekly for nine months. The study includes follow-up visits at baseline day 0, month 3 day 90, month 6 day 180, and month 9 day 270. Both treatments are applied topically to the affected nails over the entire study period to assess their effects on nail health and fungal infection. During the trial, subjects will undergo regular evaluations including visual assessments of the nails healthy surface, microbiological tests such as KOH staining, and clinical examinations for nail appearance and onychomycosis progression. Participants will also complete quality of life and subjective evaluation questionnaires. Tolerance and safety of the treatments will be monitored at multiple timepoints. The total participation duration is nine months, covering treatment and follow-up visits.

The study investigates fungal pneumonia, a serious lung infection caused by fungi, which is often hard to diagnose early due to vague symptoms and complex testing. Researchers aim to develop and validate a clinical prediction score called FUNGAL-P to help identify fungal pneumonia or fungal-bacterial coinfections in adult patients presenting with pneumonia. This observational study is conducted at a single center and includes both retrospective and prospective patient groups. The study has two main phases. The retrospective phase reviews adult patients diagnosed with pneumonia between January 2022 and December 2023 who underwent microbiological testing within 48 hours of hospital admission. The prospective phase enrolls consecutive adult patients with pneumonia from January to December 2024 to evaluate the FUNGAL-P score without affecting their clinical care. Data collected include clinical signs, laboratory and radiological findings, microbiology results, treatment details, and outcomes. Participants provide information on their medical history, vital signs, and undergo routine microbiological assessments. Researchers analyze these data to find factors that predict fungal pneumonia, combining them into the FUNGAL-P score. They will measure how well the score identifies fungal pneumonia using statistics like sensitivity, specificity, and calibration. The primary outcome is the scores accuracy assessed by the area under the receiver operating characteristic curve AUROC. The study aims to improve early detection and guide timely treatment for fungal pneumonia.

Researchers are evaluating a zinc oxide adhesive securement device to help reduce complications related to the fixation of midline and peripherally inserted central catheters PICC in hospitalized adult patients. The study aims to compare this zinc oxide device with a standard acrylic adhesive device to see if it lowers issues such as catheter displacement, skin injuries, phlebitis, and pain. The trial is a randomized clinical study designed to improve care decisions for vascular access devices by reducing common complications. Participants will be divided into two groups after catheter insertion using a modified micro-Seldinger technique. One group will receive the standard care using an acrylic adhesive securement device along with a clear polyurethane dressing and cyanoacrylate glue. The intervention group will receive the same care except their catheter will be fixed with a zinc oxide adhesive securement device instead of the acrylic adhesive. Ultrasound guidance is used for all catheter insertions to improve accuracy. During the study, researchers will observe participants for seven days following catheter placement to monitor for treatment-related adverse events, skin changes under the fixation device, catheter displacement, phlebitis using a visual rating scale, and pain in the affected limb measured by a pain scale. Participants will be monitored closely for any complications related to the catheter fixation. The total participation involves care and assessments over this week-long period to evaluate the safety and efficacy of the zinc oxide adhesive device compared to the standard adhesive.

This trial is evaluating the safety and effectiveness of a single high dose of liposomal amphotericin B compared to the standard two-week treatment for disseminated histoplasmosis in patients with AIDS. Disseminated histoplasmosis is a serious fungal infection common in immunocompromised individuals, especially those with advanced HIV. The study aims to determine if the single high dose is at least as effective as the standard treatment in reducing mortality and improving outcomes. Participants will be randomly assigned to receive either a single high dose 10 mgkg of liposomal amphotericin B or the standard daily dose 3 mgkg for two weeks. After induction therapy, all patients will receive oral itraconazole for one year. The study includes safety monitoring by a Data Safety Monitoring Board and oversight by steering and medical committees with scheduled meetings to review progress and maintain quality. During the study, participants will be assessed for overall survival at 14 days, clinical response, fungal load, and treatment-related side effects. Additional evaluations include a Desirability of Outcome Ranking score at 10 weeks and monitoring for adverse events. Data will be analyzed using statistical methods to compare outcomes between the treatment groups. The total duration includes initial treatment and follow-up assessments up to 10 weeks, with ongoing oral therapy for one year.

Researchers are conducting an observational study to develop an emergency PanorOmics Wide Association Study ePWAS focused on adult patients with suspected, acute, community-acquired respiratory infectious disease scaRID presenting in emergency departments. The study aims to create a biobank of biological samples and perform targeted research to discover new diagnostic, prognostic, and therapeutic markers for respiratory infectious diseases, which include viral, bacterial, fungal, and mixed infections, as well as pneumonia and sepsis. This research builds on previous genomic and molecular studies to better understand host responses and disease mechanisms early in the illness. Participants will provide blood and saliva samples collected mostly within 8 days of symptom onset. Those with viral, bacterial, or co-infections will have one sample taken in the emergency department or hospital, with additional samples collected at approximately 24 and 48 hours after symptom onset if they agree. Control subjects, including healthy individuals and those with low illness scores, may also provide samples on a similar schedule. The biobank will include various liquid biopsy specimens such as whole blood, plasma, serum, and salivary components to analyze multiple biological markers across genomics, proteomics, metabolomics, and other fields. During the study, participants will be monitored for up to 30 days to evaluate clinical progression using the WHO Clinical Progression Scale and mortality outcomes up to one year. Researchers will collect clinical data alongside biological samples to identify patterns that distinguish low-risk from high-risk patients. The study involves informed consent, with assessments including temperature and symptom tracking to confirm eligibility. This ongoing study is sponsored by The University of Hong Kong and will continue to gather data until at least May 2028.

Researchers are evaluating treatment options for patients with onychomycosis, a fungal nail infection. This randomized controlled trial compares itraconazole alone with itraconazole combined with either low dose isotretinoin or excimer light. The study aims to assess the effectiveness of these combinations in improving clinical outcomes for onychomycosis over six months. Participants will be divided into three groups one receiving itraconazole 200 mg twice daily for one week each month over three months a second group receiving the same itraconazole treatment plus low dose isotretinoin 20 mg every other day for three months with an additional 4-6 weeks of maintenance dosing and a third group receiving itraconazole plus excimer light therapy applied to the nails using the XeCl2 excimer light device. All treatments begin after screening blood tests to ensure safety. Participants will undergo clinical assessments and fungal cultures at the start, monthly during treatment, at the end of treatment, and three months post-treatment, totaling six months of follow-up. The severity of onychomycosis will be graded using the Onychomycosis Severity Index. Blood tests and patient-reported side effects will be monitored. The main outcomes measured are clinical improvement and fungal culture results to evaluate treatment response and durability.

Researchers are conducting an observational diagnostic study to develop and validate a new algorithm for diagnosing bacterial vaginosis and to evaluate the Nanopath assay, a molecular test that detects pathogens linked to vaginitis. The study focuses on individuals showing signs and symptoms of vaginitis and aims to compare the Nanopath assays performance with FDA-cleared commercial tests and yeast culture methods. Participants will provide vaginal swab specimens collected both by clinicians and by themselves. The study will assess the Nanopath assay, an amplification-free molecular test, alongside three FDA-cleared diagnostic tests BD Max14 Vaginal Panel, Cepheid Xpert4 Xpress MVP, and Hologic Aptima4 BV Assay, as well as yeast culture with MALDI-TOF for species identification. These comparisons will help validate the new diagnostic algorithm. During the study, participants will be asked to provide vaginal swab samples for analysis. Researchers will measure the accuracy of the Nanopath assay in diagnosing vaginal infections and compare the agreement between self-collected and clinician-collected samples. The study will collect data on symptoms and perform laboratory testing to evaluate diagnostic performance, with the primary outcome measured within one day of sample collection. Participants involvement includes sample collection and symptom reporting, with no treatment provided as part of this observational study.