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Procalcitonin Guided Antibiotic Use in Acute Respiratory Tract Infections (PARTI)-Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00099840
Recruitment Status : Completed
First Posted : December 21, 2004
Last Update Posted : April 25, 2007
Basel Institute of Clinical Epidemiology (BICE)
Brahms AG
Information provided by:
University Hospital, Basel, Switzerland

Brief Summary:

Acute respiratory tract infections (ARTI) are among the most frequent reasons for seeking medical attention in primary care. Although from predominantly viral origin, ARTIs are the most important condition for the prescription of antibiotics (AB), mainly due to the difficulty in primary care to differentiate between viral and bacterial etiology. Unnecessary AB use increases drug expenditures, side effects and AB resistance. A novel approach is to guide AB use by procalcitonin (ProCT), since serum levels are elevated in bacterial infections but remain lower in viral infections and inflammatory diseases.

We aim to compare a strategy based on evidence-based guidelines with ProCT guided AB therapy in ARTIs with respect to outcome (days with restriction) and AB use. Patients presenting with ARTIs to primary care physicians and are intended to be treated with AB based on guidelines will be included and randomized 1:1 either to standard management or to the ProCT guided prescription of AB. All participating physicians will receive evidence-based guidelines for the management of patients with ARTIs. Patients with ARTI and in need of ABs by physicians’ clinical judgment and with informed consent will be randomized to ProCT plus guidelines ("ProCT group") versus only guidelines guided AB treatment ("control group"). In patients randomized to the ProCT group, the use of antibiotics will be more or less discouraged (<0.1 or <0.25 ug/L) or encouraged (>0.5 or >0.25 ug/L), respectively. A re-evaluation in patients with ProCT (<0.1 or <0.25 ug/L) after 6 to 24 hours is mandatory. All patients will be reassessed at day 3 and it is recommended to stop AB in the ProCT group as described above. Structured phone interviews at days 14 and 28 will be done in all patients from both groups.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Procedure: Procalcitonin guided antibiotic therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Procalcitonin Guided Antibiotic Use in Acute Respiratory Tract Infections in Primary Care - A Randomized Controlled Trial
Study Start Date : December 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Primary Outcome Measures :
  1. Days with restrictions from ARTI

Secondary Outcome Measures :
  1. Rate of AB prescriptions
  2. days with AB use
  3. symptoms from ARTI
  4. relapse rate from ARTI within 28 days
  5. days with side effects from ABs and off work
  6. cost-effectiveness

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years or older
  • ARTI of >1 and <28 days duration
  • In need of ABs based on the clinical judgment of the primary care physician

Exclusion Criteria:

  • Patients without informed consent
  • Not fluent in German
  • AB pretreatment in previous 28 days
  • Severe immune-suppression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00099840

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University Hospital
Basel, CH, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Basel Institute of Clinical Epidemiology (BICE)
Brahms AG
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Study Chair: Beat Muller, MD University Hospital, Basel, Switzerland

Layout table for additonal information Identifier: NCT00099840    
Other Study ID Numbers: PARTIS
First Posted: December 21, 2004    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: January 2006
Keywords provided by University Hospital, Basel, Switzerland:
common cold
otitis media
acute exacerbations of asthma
acute exacerbations of chronic pulmonary disease
community acquired pneumonia
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents