Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

Respiratory Infections Clinical Trial

Official title:

Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907659
• Other study ID #: ABX RED-001
• Secondary ID: RGH KIDD-001
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: June 30, 2014
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized with symptoms of a respiratory infection

• Age > 21 years

• Systolic Blood Pressure > 90mm Hg

• Patient or health care designee can provide written informed consent

Exclusion Criteria:

• Intensive Care Requirement

• Antibiotics received prior to admission

• More than 24 hours of antibiotics received prior to enrollment

• Active chemotherapy or pulmonary radiation therapy

• Immunosuppressive conditions

• Conditions know to increase PCT values

• Definite infiltrate on CXR •% of band forms in peripheral blood > 15

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Respiratory Infections
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Rochester General Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Rochester General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician attitudes regarding antibiotic prescription	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	24 hours after release of intervention test results	No
Primary	Antibiotic days	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.	Total antibiotic days within 30 days after randomization	No
Secondary	Composite adverse events at 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).	30 days and 3 months	Yes