Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections

This study has been completed.

First Received on January 21, 2009. Last Updated on January 27, 2009 History of Changes

Sponsor:	Hannover Medical School
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00827060

Purpose

Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.

Condition
Respiratory Tract Infections

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover

Further study details as provided by Hannover Medical School:

Enrollment:	702
Study Start Date:	December 2006
Study Completion Date:	September 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Primary endpoint:

initial Procalcitonin values of patients with Acute Respiratory Tract Infections

Secondary endpoints:

correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections
correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections
correlation of initial Procalcitonin values to antibiotic- prescriptions
correlation of initial Procalcitonin values to frequency of admission to hospital
correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

primary care patients in 45 practices in greater Hannover

Criteria

Inclusion Criteria:

written informed consent
all types of respiratory tract infection according to investigator´s diagnosis

Exclusion Criteria:

pretreatment with antibiotics in the past 2 weeks
portal hypertension
Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
Peritoneal dialysis
Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid
Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827060

Locations

Germany
Medical School Hannover, Department Pneumology
Hannover, Germany, 30625

Sponsors and Collaborators

Hannover Medical School

Investigators

Principal Investigator:

Olaf Burkhardt, PD Dr. med.

Medical School Hannover

More Information

No publications provided by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, Hummers-Pradier E, Welte T. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J. 2010 Sep;36(3):601-7. Epub 2010 Feb 25.

Responsible Party:	Prof. Dr. med. Tobias Welte
ClinicalTrials.gov Identifier:	NCT00827060 History of Changes
Other Study ID Numbers:	HannoverPro
Study First Received:	January 21, 2009
Last Updated:	January 27, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Hannover Medical School:

primary care
procalcitonin
acute respiratory tract infection

Additional relevant MeSH terms:

Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 24, 2012