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

NCT00688610 | Completed Phase 2

• 1 other identifier: HannoverPro II
• Study Type: interventional
• Target: 571
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infection

Keywords

primary care; procalcitonin; antibiotic prescription

Outcome Measures

Primary Outcomes (1)

• days with significant impairment due to acute respiratory tract infection

  14 to 28 days after infection

Secondary Outcomes (1)

• number of antibiotic prescriptions

  28 days

Interventions

laboratory value procalcitonin OTHER

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Medical School Hannover, Department Pneumology

Hanover, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 20185423 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Olaf Burkhardt, Dr.

  Medical School Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: June 3, 2008
• Study Start: November 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

DE (1)