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Antibiotics in Patients With Acute Respiratory Tract Infection With Procalcitonin as Parameter

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00688610
First received: May 15, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes

May 15, 2008
January 27, 2009
November 2007
June 2008   (final data collection date for primary outcome measure)
days with significant impairment due to acute respiratory tract infection [ Time Frame: 14 to 28 days after infection ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00688610 on ClinicalTrials.gov Archive Site
number of antibiotic prescriptions [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Antibiotics in Patients With Acute Respiratory Tract Infection With Procalcitonin as Parameter
Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter

Antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter.

The purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.
 
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Tract Infection
Other: laboratory value procalcitonin

A. attending physician includes patient with acute respiratory infection in study, indicates antibiotic prescription and collects procalcitonin-value. Waits for decision from laboratory either "change of decision" or "retention of decision". In case of "change decision": antibiotic is not recommended, patient shall not take antibiotic. In case of "retention of decision": patient may take the antibiotic.

B. attending physician includes patient with acute respiratory infection in study, indicates NO antibiotic and collects procalcitonin-value. Waits for decision from laboratory either "change of decision" or "retention of decision". In case of "change decision": antibiotic is recommended, patient has to be informed about. In case of "retention of decision": no change.
 
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
571
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Informed consent
  • Respiratory tract infection based on the clinical judgement of the primary care physician

Exclusion Criteria:

  • Antibiotic pretreatment in previous 14 days
  • 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
 
NCT00688610
HannoverPro II
No
Prof. Dr. med. Tobias Welte
Hannover Medical School
 
Principal Investigator: Olaf Burkhardt, Dr. 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