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

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ClinicalTrials.gov Identifier: NCT00914550
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pneumonia Radiographic Lung Infiltrates Other: Procalcitonin level, caregiver informed

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.

Study Design

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia
Study Start Date : June 2009
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Pneumonia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

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
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

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): 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
ClinicalTrials.gov Identifier: NCT00914550     History of Changes
Other Study ID Numbers: 107003-3
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Michael S. Niederman, M.D., 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