Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/5/2014 |
| Start Date: | October 2013 |
| End Date: | September 2014 |
| Contact: | Ann R Falsey, MD |
| Email: | ann.falsey@rochestergeneral.org |
| Phone: | 585-922-4339 |
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.
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.
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.
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.
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
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