Clinical trial NCT01907659: Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
Official title: Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infections
Keywords: Respiratory
Viruses
Bacterial
Antibiotics
Procalcitonin
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Rochester General Hospital
First posted: 2013-07-25
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Antibiotic days
timeFrame: Total antibiotic days within 30 days after randomization
Secondary outcomes:
measure: Composite adverse events at 30 days and 3 months
timeFrame: 30 days and 3 months
Other outcomes:
measure: Physician attitudes regarding antibiotic prescription
timeFrame: 24 hours after release of intervention test results
Locations:
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
Study officials:
affiliation: University of Rochester
name: Ann R Falsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.