Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT01907659

Collaborator

Rochester General Hospital (Other)

300

Enrollment

Location

Arms

Duration (Months)

37.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Infections	Other: Release of test results	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of care Standard of care for respiratory infections
Experimental: Release of test results Health care providers will receive viral PCR and PCT test results along with an algorithm recommending antibiotic treatment based on PCT level.	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 Other Names: Viral PCR Serum Procalcitonin

Arm

Intervention/Treatment

No Intervention: Standard of care

Standard of care for respiratory infections

Experimental: Release of test results

Health care providers will receive viral PCR and PCT test results along with an algorithm recommending antibiotic treatment based on PCT level.

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

Other Names:

Viral PCR

Serum Procalcitonin

Outcome Measures

Primary Outcome Measures

Antibiotic days [Total antibiotic days within 30 days after randomization]
The primary patient-level outcome is the number of days on antibiotics after randomization. The primary null hypothesis is that the distribution of the number of days on antibiotics is identical for the standard-of-care versus intervention arm, where the latter includes those patients for whom the PCT-intervention recommendation was overruled by the care team.

Secondary Outcome Measures

Composite adverse events at 30 days and 3 months [30 days and 3 months]
The secondary analyses will compare the following outcome variables between the intervention and the standard care group. Outcome variables will include total antibiotic related complications, length of hospitalization, a composite of 30 day and 3 month adverse events (death, ICU transfer, disease specific complications [development of pneumonia, lung abscess, empyema or ARDS] and recurrent LRTI requiring hospitalization).

Other Outcome Measures

Physician attitudes regarding antibiotic prescription [24 hours after release of intervention test results]
Physicians will be queried 24 hours after release of intervention results of viral testing and PCT values to understand factors associated with continuing or stopping antibiotics