Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

Not Applicable

Completed

• Conditions: Respiratory Infections
• Interventions: Other: Release of test results

• Registration Number: NCT01907659
• Lead Sponsor: University of Rochester

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-25
• Study Start: 2013-10
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Release of test results	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Rochester General Hospital; 🇺🇸 Rochester, New York, United States