Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

University of Rochester

Status: Completed

Conditions: Respiratory Infections

Treatments: Other: Release of test results

Study type: Interventional

Funder types: Other

Identifiers

NCT01907659

RGH KIDD-001 (Other Identifier)

ABX RED-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Standard of care for respiratory infections

Release of test results

Experimental group

Description:

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

Treatment:

Other: Release of test results