NCT03894488

Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients

Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days after HSCT (T2), and the day severe diarrhea present (T3). All the stool samples will be detected by the FilmArray GI panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.

Conditions

• GVHD - Graft-Versus-Host Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FilmArray Gastrointestinal (GI) Panel	The FilmArray GI Panel tests for 22 of the most commonly associated pathogens related to gastroenteritis-all from one patient sample, one easy to use reagent, and results are available in about one hour.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-05-31
• Completion: 2020-12-31
• First posted: 2019-03-28
• Last updated: 2019-03-28