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

NCT00221351 | Completed

• 2 other identifiers: CRP-1IMPAACT- AHRQ/ VAMC
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

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. 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. 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).

Conditions

Cough

Keywords

cough; acute bronchitis; upper respiratory tract infection; pneumonia; lower respiratory tract infection

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Satisfaction with care

Interventions

CRP point of care testing PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Previous (within 21 days) antibiotic treatment;
• immunodeficiency;
• cystic fibrosis;
• patient requiring immediate evaluation/management;
• inability to provide informed consent.

Sponsors & Collaborators

• University of California, San Francisco: lead
• US Department of Veterans Affairs: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (1)

• Smedemark SA, Aabenhus R, Llor C, Fournaise A, Olsen O, Jorgensen KJ. Biomarkers as point-of-care tests to guide prescription of antibiotics in people with acute respiratory infections in primary care. Cochrane Database Syst Rev. 2022 Oct 17;10(10):CD010130. doi: 10.1002/14651858.CD010130.pub3.

  PMID: 36250577 DERIVED

MeSH Terms

Conditions

Cough; Bronchitis; Respiratory Tract Infections; Pneumonia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Ralph Gonzales, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Joshua Metlay, MD

  VAMC Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: July 1, 2006
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

US (2)