NCT01907659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

June 27, 2013

Last Update Submit

June 30, 2014

Conditions

Respiratory Infections

Keywords

RespiratoryVirusesBacterialAntibioticsProcalcitonin

Outcome Measures

Primary Outcomes (1)

  • 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.

    Total antibiotic days within 30 days after randomization

Secondary Outcomes (1)

  • Composite adverse events at 30 days and 3 months

    30 days and 3 months

Other Outcomes (1)

  • Physician attitudes regarding antibiotic prescription

    24 hours after release of intervention test results

Study Arms (2)

Standard of care

NO INTERVENTION

Standard of care for respiratory infections

Release of test results

EXPERIMENTAL

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

Interventions

Release of test resultsOTHER

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
Release of test results

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Related Publications (1)

  • 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.

    PMID: 25910632DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Ann R Falsey, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 25, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 2, 2014

Record last verified: 2014-06

Locations

US(1)