Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients
1 other identifier
observational
150
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 28, 2019
March 1, 2019
1 year
March 22, 2019
March 27, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Positive rate of FilmArray GI test before and post-HSCT
31 days after HSCT
Compare the FilmArray GI test results generated from the same patients in different time points
31 days after HSCT
Interventions
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.
Eligibility Criteria
All patients receiving HSCT within the year at SCMC
You may qualify if:
- Age ≤ 18 years old;
- Receiving HSCT;
- Legal guardians fully understand and sign informed consent.
You may not qualify if:
- Receiving secondary transplantation;
- Cannot give informed consent or not willing to enroll the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Children's Medical Centerlead
- BioMérieuxcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Infectious Diseases
Study Record Dates
First Submitted
March 22, 2019
First Posted
March 28, 2019
Study Start
June 1, 2019
Primary Completion
May 31, 2020
Study Completion
December 31, 2020
Last Updated
March 28, 2019
Record last verified: 2019-03