Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-27 @ 6:33 PM
Study NCT ID:
NCT00914550
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2009-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077740', 'term': 'Procalcitonin'}], 'ancestors': [{'id': 'D002116', 'term': 'Calcitonin'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Serum Procalcitonin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2009-06-04', 'studyFirstSubmitQcDate': '2009-06-04', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in antibiotic discontinuation as an effect of the caregivers learning Procalcitonin levels for the therapy of new radiographic lung infiltrates', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Lung Infiltrates', 'Antibiotic discontinuation', 'De-escalation therapy'], 'conditions': ['Pneumonia', 'Radiographic Lung Infiltrates']}, 'referencesModule': {'references': [{'pmid': '19353770', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19131448', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18986278', 'type': 'BACKGROUND', '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.'}, {'pmid': '18677519', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18245147', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17959634', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17615073', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16603606', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://thoracic.org/statements/resources/mtpi/idsaats-cap.pdf', 'label': 'Guidelines on the management of Community-acquired Pneumonia by Infections Diseases Society of America and American Thoracic Society'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults admitted to Winthrop University Hospital with Lung Infiltrates undergoing antibiotic therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* New radiographic findings consistent with the presence of infiltrates\n* Antibiotic therapy\n\nExclusion Criteria:\n\n* Critically ill patients on admission'}, 'identificationModule': {'nctId': 'NCT00914550', 'briefTitle': 'Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Winthrop University Hospital'}, 'officialTitle': 'Use Of Procalcitonin Level For Guidance of The Treatment of Suspected Community Acquired Pneumonia', 'orgStudyIdInfo': {'id': '107003-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Procalcitonin level, caregiver informed', 'description': 'Procalcitonin level for patients with lung infiltrates:caregivers know/ do not know results', 'interventionNames': ['Other: Procalcitonin level, caregiver informed']}], 'interventions': [{'name': 'Procalcitonin level, caregiver informed', 'type': 'OTHER', 'description': "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", 'armGroupLabels': ['Procalcitonin level, caregiver informed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop-University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}], 'overallOfficials': [{'name': 'Michael Niederman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Winthrop University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael S. Niederman, M.D.', 'investigatorAffiliation': 'Winthrop University Hospital'}}}}