Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Michael S. Niederman, M.D., Winthrop University Hospital Identifier:
First received: June 4, 2009
Last updated: December 12, 2014
Last verified: December 2014
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
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:

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 ]

Biospecimen Retention:   None Retained
Serum Procalcitonin

Enrollment: 47
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults admitted to Winthrop University Hospital with Lung Infiltrates undergoing antibiotic therapy

Inclusion Criteria:

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

Exclusion Criteria:

  • Critically ill patients on admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00914550

United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Principal Investigator: Michael Niederman, MD Winthrop University Hospital
  More Information

Additional Information:

Responsible Party: Michael S. Niederman, M.D., Principal Investigator, Winthrop University Hospital Identifier: NCT00914550     History of Changes
Other Study ID Numbers: 107003-3
Study First Received: June 4, 2009
Last Updated: December 12, 2014

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

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 22, 2017