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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
  Purpose

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.


Condition Intervention Phase
Respiratory Tract Infection
 Other: laboratory value procalcitonin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • days with significant impairment due to acute respiratory tract infection [ Time Frame: 14 to 28 days after infection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of antibiotic prescriptions [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 571
Study Start Date: November 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688610

Locations
Germany
Medical School Hannover, Department Pneumology
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Olaf Burkhardt, Dr. 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: NCT00688610     History of Changes
Other Study ID Numbers: HannoverPro II
Study First Received: May 15, 2008
Last Updated: January 27, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
primary care
procalcitonin
antibiotic prescription

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013