Viewing Study NCT02130986



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Last Modification Date: 2024-10-26 @ 11:23 AM
Study NCT ID: NCT02130986
Status: COMPLETED
Last Update Posted: 2019-01-15
First Post: 2014-05-01

Brief Title: Procalcitonin Antibiotic Consensus Trial ProACT
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Procalcitonin Antibiotic Consensus Trial ProACT
Status: COMPLETED
Status Verified Date: 2019-01
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: ProACT
Brief Summary: The ProACT study is a 5 year multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department ED patients with Lower Respiratory Tract Infection LRTI
Detailed Description: There is a need for improved decision-making for antibiotic prescription in acute suspected infection Infections particularly in the early stages can have protean manifestations often do not manifest with classic signs and clinically overlap with non-infectious conditions However the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance

Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology cardiology and other fields These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care This approach takes diagnostics to the next level by demanding a test not only measure well but also that clinical care be improved by tying the test to a treatment strategy

Procalcitonin a novel biomarker of bacterial infection may help physicians make more appropriate antibiotic decisions Lower respiratory tract infection LRTI is an ideal trial population LRTI accounts for a large proportion of antibiotic prescription and exemplifies the imprecise clinical phenotype of infectionHowever key questions of generalizability and safety preclude widespread application

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R01GM101197 NIH None httpsreporternihgovquickSearch1R01GM101197