Clinical Research Directory

Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Participants will be assigned to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care. The primary objective is to assess agreement between AI-generated diagnoses and clinician diagnoses obtained during study encounters, including telehealth evaluations in the Diagnostik arm and in-person evaluations in the standard-of-care arm. Secondary objectives include evaluating agreement between AI-generated diagnoses and independent research team diagnoses, as well as assessing usability, patient and caregiver satisfaction, healthcare utilization, and clinical outcomes such as asthma control and symptom resolution. This study will also evaluate differences in healthcare utilization, including in-person visits, emergency care use, and time to diagnosis and treatment, between study groups.

Safety and Efficacy of wSp Vaccine in Young Children

The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV20 vaccination. The main questions it aims to answer are: Does wSp vaccine reduce pneumococcal colonization in the nose? Does wSp vaccine safely stimulate the immune system to produce antibodies and protective immune responses? Researchers will compare children receiving two injections of wSp vaccine to those receiving saline placebo to see if wSp vaccine reduces colonization and boosts immunity. Participants will: Receive two injections of either wSp or saline at 7 and 9 months of age. Have blood samples taken at 6 and 12 months to measure immune responses. Have nasal swabs collected at several time points and during infections from 6-24 months. Be monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections.

Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care

Antimicrobial resistance (AMR), considered one of the greatest global threats by the WHO, justifies the development of initiatives to promote appropriate antibiotic use-especially in primary care, where most antibiotics in France are prescribed and where misuse remains common. We are proposing a cluster-randomized controlled trial to evaluate the effectiveness of a bimodal intervention combining: (1) improved communication about the circulation of respiratory viruses, and (2) strengthened collaborative practices between general practitioners and pharmacists through a multidisciplinary protocol aimed at verifying that prescribed treatment durations comply with guidelines. The study will include six primary care practices (24 physicians), with three practices in each study arm. The aim of this project is to assess whether the bimodal intervention can reduce the duration of antibiotic treatments for upper and lower respiratory tract infections. The first component (a "viral infection prescription" tool) focuses on reducing unnecessary treatment initiation, while the second (pharmacist-led review) aims to shorten excessive prescription durations.

Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds

Ear infections are common in young children with cold symptoms, but they can be difficult to diagnose due to small ear canals, child movement, and limited viewing time. In this study, investigators will take photos of the eardrums of children 6-24 months of age with upper respiratory symptoms. The photos will be reviewed by imaging software enhanced with artificial intelligence (AI app) to determine whether the AI app changes how ear infections are diagnosed and treated. The AI app has undergone rigorous study and was found to be highly accurate; but how using this technology affects the diagnosis and treatment by clinicians has not been studied. This research may help improve diagnostic accuracy for ear infections and ensure antibiotics are prescribed only for those children who have definite ear infections.

Reducing Antibiotic Use by Implementation of Stewardship in Primary and Urgent Care

The goal of this project is to reduce unnecessary antibiotic use for children with ARTIs (Acute Respiratory Tract Infections) by implementing "outpatient antibiotic stewardship" across the Children's Hospital of Philadelphia (CHOP) Primary and Urgent Care Network to: 1. Reduce unnecessary antibiotic prescribing for the most common infections in children. 2. Reduce unnecessary a) broad-spectrum and b) longer-course antibiotic therapy for ear infections, Strep throat, sinus infections, and pneumonia.