Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia - Full Text View

Sponsored by:	Winthrop University Hospital
Information provided by:	Winthrop University Hospital
ClinicalTrials.gov Identifier:	NCT00914550

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:	Case Control, Prospective
Official Title:	Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Caregivers Pneumonia

Drug Information available for: Procalcitonin

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

Biospecimen Description:

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
Mineola, New York, United States, 11501

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:

Niederman MS. Making sense of scoring systems in community acquired pneumonia. Respirology. 2009 Apr;14(3):327-35.

Menéndez R, Martinez R, Reyes S, Mensa J, Filella X, Marcos MA, Martinez A, Esquinas C, Ramirez P, Torres A. Biomarkers improve mortality prediction by prognostic scales in community-acquired pneumonia. Thorax. 2009 Jan 8; [Epub ahead of print]

Niederman MS. Biological markers to determine eligibility in trials for community-acquired pneumonia: a focus on procalcitonin. Clin Infect Dis. 2008 Dec 1;47 Suppl 3:S127-32. Review.

Haeuptle J, Zaborsky R, Fiumefreddo R, Trampuz A, Steffen I, Frei R, Christ-Crain M, Müller B, Schuetz P. Prognostic value of procalcitonin in Legionella pneumonia. Eur J Clin Microbiol Infect Dis. 2009 Jan;28(1):55-60. Epub 2008 Aug 2.

Menéndez R, Cavalcanti M, Reyes S, Mensa J, Martinez R, Marcos MA, Filella X, Niederman M, Torres A. Markers of treatment failure in hospitalised community acquired pneumonia. Thorax. 2008 May;63(5):447-52. Epub 2008 Feb 1.

Ramirez P, Garcia MA, Ferrer M, Aznar J, Valencia M, Sahuquillo JM, Menéndez R, Asenjo MA, Torres A. Sequential measurements of procalcitonin levels in diagnosing ventilator-associated pneumonia. Eur Respir J. 2008 Feb;31(2):356-62. Epub 2007 Oct 24.

Schuetz P, Christ-Crain M, Wolbers M, Schild U, Thomann R, Falconnier C, Widmer I, Neidert S, Blum CA, Schönenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Müller B; ProHOSP study group. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial. BMC Health Serv Res. 2007 Jul 5;7:102.

Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin Guidance of Antibiotic Therapy in Community-acquired Pneumonia: A Randomized Trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. Epub 2006 Apr 7.

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

Keywords provided by Winthrop University Hospital:

Pneumonia
Lung Infiltrates
Antibiotic discontinuation
De-escalation therapy

Study placed in the following topic categories:

Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

Additional relevant MeSH terms:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on September 03, 2009