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

Respiratory Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688610
• Other study ID #: HannoverPro II
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: January 27, 2009
• Start date: November 2007
• Est. completion date: June 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days with significant impairment due to acute respiratory tract infection		14 to 28 days after infection	Yes
Secondary	number of antibiotic prescriptions		28 days	Yes