NCT01907659

Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.

Detailed description

This is trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined. In addition, the added benefit of viral diagnosis to that of serum procalcitonin alone in reducing antibiotics will be determined. Lastly, antibiotic related complications and clinical outcomes to determine the safety of this approach at 30 days and 3 months in the standard care and intervention group will be evaluated. Analysis of the composite adverse event outcome (death, intensive care unit transfer, disease specific complications and recurrent respiratory tract infection requiring hospitalization) will serve as the principle safety analysis for the study. In addition, each adverse outcome will be examined individually as well as lesser adverse outcomes including antibiotic prescriptions, time to return to baseline health, patient reported outcomes and functional status at 30 days and 3 months. Physicians will be queried to determine factors which drive antibiotic prescriptions and potential barriers to implementing antibiotic reduction algorithms. These data will be used to design a phase III clinical trial with the intent to demonstrate that physicians in the US will respond appropriately to this information and that antibiotic use can be significantly and safely curtailed.

Conditions

• Respiratory Infections

Interventions

Type	Name	Description
OTHER	Release of test results	Subjects will be randomized to have viral testing and serum PCT results released or no additional testing performed other than that ordered as standard of care

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-07-25
• Last updated: 2014-07-02

Locations

1 site across 1 country: United States