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Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Winthrop University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00914550
First received: June 4, 2009
Last updated: April 29, 2010
Last verified: April 2010
History of Changes
  Purpose

The purpose of the study is to learn if a blood test is helpful to the doctors in deciding whether you need antibiotic therapy for possible pneumonia. The blood test is called a Procalcitonin level and sometimes the test reflects infection with certain bacteria (germs). When the doctors learn the results of these blood tests, they may be able to stop some of the antibiotic medications that they may have given to the patients. The study is designed, so that on a randomized basis (50/50 chance) the results from measuring Procalcitonin will be given to the patients' doctor. When the doctor receives these results, he/she may use this information, along with other information, to decide whether to continue antibiotic therapy.


Condition Intervention
Pneumonia
Radiographic Lung Infiltrates
 Other: Procalcitonin level, caregiver informed

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Differences in antibiotic discontinuation as an effect of the caregivers learning Procalcitonin levels for the therapy of new radiographic lung infiltrates [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Serum Procalcitonin


Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Procalcitonin level, caregiver informed
Procalcitonin level for patients with lung infiltrates:caregivers know/ do not know results
 Other: Procalcitonin level, caregiver informed
Procalcitonin levels will be measured and known by investigator, only 1/2 of the patients' caregivers will know the results of serial Procalcitonin levels. We will analyze the rate of antibiotic discontinuation for the two arms

Detailed Description:

To evaluate the usefulness of serum Procalcitonin level measured to guide the antibiotic treatment of patients with radiographic lung infiltrates.The subjects involved in the study will be divided in two arms ,study arm where the caregivers will know the result of Procalcitonin level and they can change /withheld the antibiotic for the subjects.In other arm only investigators will know the Procalcitonin level. We expect to enroll 100 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults admitted to Winthrop University Hospital with Lung Infiltrates undergoing antibiotic therapy

Criteria

Inclusion Criteria:

  • Adults
  • New radiographic findings consistent with the presence of infiltrates
  • Antibiotic therapy

Exclusion Criteria:

  • Critically ill patients on admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914550

Contacts
Contact: Michael Niederman, MD 516-663-4637 mniederman@winthrop.org
Contact: Shweta Upadhyay, MD 516-663-2588 SUpadhyay@winthrop.org

Locations
United States, New York
Winthrop-University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Michael Niederman, MD     516-663-4637     mniederman@winthrop.org    
Contact: Shweta Upadhyay, MD     516-663-2588     SUpadhyay@winthrop.org    
Principal Investigator: Michael Niederman, MD            
Sub-Investigator: Shweta Upadhyay, MD            
Sub-Investigator: Veronica Brito, MD            
Sub-Investigator: Chrisoula Politis, MD            
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Michael Niederman, MD Winthrop University Hospital
  More Information

Additional Information:
Winthrop-University Hospital website  This link exits the ClinicalTrials.gov site
Guidelines on the management of Community-acquired Pneumonia by Infections Diseases Society of America and American Thoracic Society  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Michael Niederman, MD, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00914550     History of Changes
Other Study ID Numbers: 107003-3
Study First Received: June 4, 2009
Last Updated: April 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Pneumonia
Lung Infiltrates
Antibiotic discontinuation
De-escalation therapy

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 16, 2013