Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07362433
Description:
The study will generate multiple gigabytes of de-identified individual-level data, shared as non-proprietary formats (.csv for tabular data; .wav for audio). Outcomes include treatment failure at Days 7 and 14, time to treatment failure, relapse by Day 14, modified treatment failure, outcomes stratified by age, sex, and clinic, and correct lower respiratory infection diagnosis. No participant identifiers will be shared. Metadata will include participant identification (ID) and a data dictionary. Associated documentation will include data collection instruments, methods, and final protocols. Data will be provided in formats accessible without specialized software. Common data elements, best practices, and standardized reporting approaches will be used where feasible. De-identified data, statistical analysis plans, and analytic code will be shared without restriction via public download.
Study:
NCT07362433
Study Brief:
Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship