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C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221351
First Posted: September 22, 2005
Last Update Posted: May 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
VA Office of Research and Development
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of California, San Francisco
  Purpose

We aim to evaluate the impact of a CRP-guided management algorithm for adults with acute cough illness. More specifically, we will examine both process of care and clinical outcomes:

  1. Processes of care (i.e., chest x-rays ordered, antibiotic treatment, length-of-time in the ED). We hypothesize that CRP-guided management will be associated with a decrease in the antibiotic prescription for acute cough illness from 50 percent to 30 percent.
  2. Clinical outcomes (i.e., duration of illness, any return visit, return visit with a diagnosis of pneumonia, hospitalization, subsequent antibiotic use, satisfaction with care). We hypothesize that there will be no difference in the proportion of patients feeling back to normal within 2 weeks of their ED visit for acute cough illness (about 60 percent, 95% confidence interval=50 to 70 percent).

Condition Intervention
Cough Procedure: CRP point of care testing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized, Controlled Trial of a C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough Illness in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Chest X-ray utilization, Antibiotic treatment, Time in emergency department, Subsequent office or emergency department visits (within 2 weeks; Subsequent hospitalization, Time-to-illness resolution

Secondary Outcome Measures:
  • Satisfaction with care

Enrollment: 139
Study Start Date: October 2005
Study Completion Date: July 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (age > 18 years) seeking care for an acute respiratory illness (duration < 10 days) in which cough is a chief complaint.
  • Eligible patients will be required to have at least 1 symptom of acute respiratory tract infection (fever, night sweats, rhinorrhea, sinus congestion, myalgias).

Exclusion Criteria:

  • Previous (within 21 days) antibiotic treatment;
  • immunodeficiency;
  • cystic fibrosis;
  • patient requiring immediate evaluation/management;
  • inability to provide informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221351


Locations
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
University of California, San Francisco
VA Office of Research and Development
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Ralph Gonzales, MD University of California, San Francisco
Principal Investigator: Joshua Metlay, MD VAMC Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00221351     History of Changes
Other Study ID Numbers: CRP-1
IMPAACT- AHRQ/ VAMC
First Submitted: September 19, 2005
First Posted: September 22, 2005
Last Update Posted: May 23, 2011
Last Verified: May 2011

Keywords provided by University of California, San Francisco:
cough
acute bronchitis
upper respiratory tract infection
pneumonia
lower respiratory tract infection

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms