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

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00827060
First received: January 21, 2009
Last updated: January 27, 2009
Last verified: January 2009
History of Changes

January 21, 2009
January 27, 2009
December 2006
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00827060 on ClinicalTrials.gov Archive Site
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Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections
Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover

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.

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)
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

primary care patients in 45 practices in greater Hannover
Respiratory Tract Infections
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
702
September 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00827060
HannoverPro
No
Prof. Dr. med. Tobias Welte
Hannover Medical School
Not Provided
Principal Investigator: Olaf Burkhardt, PD Dr. med. Medical School Hannover
Hannover Medical School
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP