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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014