Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

NCT ID: NCT01907659

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Standard of care for respiratory infections

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Release of test results

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Viral PCR; Serum Procalcitonin

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rochester General Hospital

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ann Falsey

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann R Falsey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Rochester General Hospital

Rochester, New York, United States

Countries

United States

References

Branche AR, Walsh EE, Vargas R, Hulbert B, Formica MA, Baran A, Peterson DR, Falsey AR. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial. J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.

Reference Type: DERIVED

PMID: 25910632 (View on PubMed)

Other Identifiers

RGH KIDD-001

Identifier Type: OTHER

Identifier Source: secondary_id

ABX RED-001

Identifier Type: -

Identifier Source: org_study_id