An interventional study of Release of test results in Respiratory Infections, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 300 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
Standard of care for respiratory infections
Health care providers will receive viral PCR and PCT test results along with an algorithm recommending antibiotic treatment based on PCT level.
Other: 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
Also known as: Viral PCR, Serum Procalcitonin
Antibiotic days
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.
Time frame: Total antibiotic days within 30 days after randomization
Composite adverse events at 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).
Time frame: 30 days and 3 months
Physician attitudes regarding antibiotic prescription
Physicians will be queried 24 hours after release of intervention results of viral testing and PCT values to understand factors associated with continuing or stopping antibiotics
Time frame: 24 hours after release of intervention test results
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University of Rochester