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NCT00914550 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00914550
Other study ID # 107003-3
Secondary ID
Status Completed
Phase N/A
First received June 4, 2009
Last updated December 12, 2014
Start date June 2009
Est. completion date September 2012

Study information
Verified date December 2014
Source Winthrop University Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults

- New radiographic findings consistent with the presence of infiltrates

- Antibiotic therapy

Exclusion Criteria:

- Critically ill patients on admission

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Winthrop-University Hospital Mineola New York

Sponsors (1)
Lead Sponsor Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Christ-Crain M, Stolz D, Bingisser R, Müller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Müller 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. — View Citation

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. doi: 10.1007/s10096-008-0592-5. Epub 2008 Aug 2. — View Citation

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. doi: 10.1136/thx.2007.086785. Epub 2008 Feb 1. — View Citation

Menéndez R, Martínez R, Reyes S, Mensa J, Filella X, Marcos MA, Martínez 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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in antibiotic discontinuation as an effect of the caregivers learning Procalcitonin levels for the therapy of new radiographic lung infiltrates 1 year No
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