Antibiotics in Patients With Acute Respiratory Tract Infection With Procalcitonin as Parameter - Full Text View

Sponsored by:	Hannover Medical School
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00688610

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 II

MedlinePlus related topics: Antibiotics

Drug Information available for: Procalcitonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter

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
Estimated Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Responsible Party:	Prof. Dr. med. Tobias Welte ( Prof. Dr. med. Tobias Welte )
Study ID Numbers:	HannoverPro II
Study First Received:	May 15, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00688610
Health Authority:	Germany: Ethics Commission

Keywords provided by Hannover Medical School:

primary care
procalcitonin
antibiotic prescription

Study placed in the following topic categories:

Respiratory Tract Diseases
Respiratory Tract Infections

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009