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

NCT ID: NCT00914550

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia Radiographic Lung Infiltrates

Keywords

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Pneumonia Lung Infiltrates Antibiotic discontinuation De-escalation therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Procalcitonin level, caregiver informed

Procalcitonin level for patients with lung infiltrates:caregivers know/ do not know results

Procalcitonin level, caregiver informed

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Critically ill patients on admission
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Winthrop University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael S. Niederman, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Niederman, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

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Winthrop-University Hospital

Mineola, New York, United States

Site Status

Countries

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United States

References

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Niederman MS. Making sense of scoring systems in community acquired pneumonia. Respirology. 2009 Apr;14(3):327-35. doi: 10.1111/j.1440-1843.2009.01494.x.

Reference Type BACKGROUND
PMID: 19353770 (View on PubMed)

Menendez 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 Jul;64(7):587-91. doi: 10.1136/thx.2008.105312. Epub 2009 Jan 8.

Reference Type BACKGROUND
PMID: 19131448 (View on PubMed)

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. doi: 10.1086/591393.

Reference Type BACKGROUND
PMID: 18986278 (View on PubMed)

Haeuptle J, Zaborsky R, Fiumefreddo R, Trampuz A, Steffen I, Frei R, Christ-Crain M, Muller B, Schuetz P. Prognostic value of procalcitonin in Legionella pneumonia. Eur J Clin Microbiol Infect Dis. 2009 Jan;28(1):55-60. doi: 10.1007/s10096-008-0592-5. Epub 2008 Aug 2.

Reference Type BACKGROUND
PMID: 18677519 (View on PubMed)

Menendez 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. doi: 10.1136/thx.2007.086785. Epub 2008 Feb 1.

Reference Type BACKGROUND
PMID: 18245147 (View on PubMed)

Ramirez P, Garcia MA, Ferrer M, Aznar J, Valencia M, Sahuquillo JM, Menendez R, Asenjo MA, Torres A. Sequential measurements of procalcitonin levels in diagnosing ventilator-associated pneumonia. Eur Respir J. 2008 Feb;31(2):356-62. doi: 10.1183/09031936.00086707. Epub 2007 Oct 24.

Reference Type BACKGROUND
PMID: 17959634 (View on PubMed)

Schuetz P, Christ-Crain M, Wolbers M, Schild U, Thomann R, Falconnier C, Widmer I, Neidert S, Blum CA, Schonenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Muller 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. doi: 10.1186/1472-6963-7-102.

Reference Type BACKGROUND
PMID: 17615073 (View on PubMed)

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. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.

Reference Type BACKGROUND
PMID: 16603606 (View on PubMed)

Related Links

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http://thoracic.org/statements/resources/mtpi/idsaats-cap.pdf

Guidelines on the management of Community-acquired Pneumonia by Infections Diseases Society of America and American Thoracic Society

Other Identifiers

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107003-3

Identifier Type: -

Identifier Source: org_study_id