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Completed

NCT Number: NCT01907659

Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections

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.

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Key information

Conditions

Respiratory Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rochester General Hospital

Rochester, New York, 14621, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Release of test results

Other

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

Other names: Viral PCR, Serum Procalcitonin

Primary outcomes

  1. Antibiotic days

    Time frame: 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 outcomes

  1. Composite adverse events at 30 days and 3 months

    Time frame: 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).

Other outcomes

  1. Physician attitudes regarding antibiotic prescription

    Time frame: 24 hours after release of intervention test results

    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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Rochester General Hospital

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2013
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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