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

Primary Purpose

Respiratory Tract Infection

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

laboratory value procalcitonin

About this trial

This is an interventional treatment trial for Respiratory Tract Infection focused on measuring primary care, procalcitonin, antibiotic prescription

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical School Hannover, Department Pneumology

Outcomes

Primary Outcome Measures

days with significant impairment due to acute respiratory tract infection

Secondary Outcome Measures

number of antibiotic prescriptions

Full Information

NCT ID

NCT00688610

First Posted

May 15, 2008

Last Updated

January 27, 2009

Sponsor

Hannover Medical School

1. Study Identification

Unique Protocol Identification Number

NCT00688610

Brief Title

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

Official Title

Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hannover Medical School

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Tract Infection

Keywords

primary care, procalcitonin, antibiotic prescription

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

571 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

laboratory value procalcitonin

Intervention Description

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.

Primary Outcome Measure Information:

Title

days with significant impairment due to acute respiratory tract infection

Time Frame

14 to 28 days after infection

Secondary Outcome Measure Information:

Title

number of antibiotic prescriptions

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olaf Burkhardt, Dr.

Organizational Affiliation

Medical School Hannover

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical School Hannover, Department Pneumology

City

Hannover

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

20185423

Citation

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. doi: 10.1183/09031936.00163309. Epub 2010 Feb 25.

Results Reference

derived

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

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