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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00827060
Other study ID # HannoverPro
Secondary ID
Status Completed
Phase N/A
First received January 21, 2009
Last updated January 27, 2009
Start date December 2006
Est. completion date September 2007

Study information

Verified date January 2009
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 702
Est. completion date September 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Germany Medical School Hannover, Department Pneumology Hannover

Sponsors (1)

Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

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