Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06331364
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-15
Brief Title:
TREATment of Lower Respiratory Tract Infection in Sri Lanka TREAT-SL
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
TREATment of Lower Respiratory Tract Infection in Sri Lanka TREAT-SL A Stepped-wedge Cluster Randomized Trial of an Electronic Clinical Decision Support Tool eCDST for the Diagnosis and Treatment of Lower Respiratory Tract Infection LRTI in Southern Sri Lanka
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAT-SL
Brief Summary:
This is a stepped-wedge cluster-randomized two-arm open-label clinical trial of an electronic clinical decision support tool eCDST for the diagnosis and treatment of lower respiratory tract infection LRTI among patients at three sites in Southern Province Sri Lanka
The primary objective of this trial is to determine the impact of an electronic clinical decision support tool eCDST on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group
The study will enroll 765 patients 14 years of age Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed
The primary objective of this trial is to determine the impact of an electronic clinical decision support tool eCDST on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group
The study will enroll 765 patients 14 years of age Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI168420 | NIH | None | httpsreporternihgovquickSearchR01AI168420 |