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

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ClinicalTrials.gov Identifier: NCT00221351
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 23, 2011
Sponsor:
Collaborators:
VA Office of Research and Development
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of California, San Francisco

Brief Summary:

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 or disease Intervention/treatment Phase
Cough Procedure: CRP point of care testing Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Satisfaction with care


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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.

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

ClinicalTrials.gov Identifier: NCT00221351     History of Changes
Other Study ID Numbers: CRP-1
IMPAACT- AHRQ/ VAMC
First Posted: September 22, 2005    Key Record Dates
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