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Sponsors and Collaborators: |
University Hospital, Basel, Switzerland Basel Institute of Clinical Epidemiology (BICE) Brahms AG |
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Information provided by: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00099840 |
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 | Intervention |
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Respiratory Tract Infections |
Procedure: Procalcitonin guided antibiotic therapy |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Procalcitonin Guided Antibiotic Use in Acute Respiratory Tract Infections in Primary Care - A Randomized Controlled Trial |
Estimated Enrollment: | 400 |
Study Start Date: | December 2004 |
Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland, CH | |
University Hospital | |
Basel, CH, Switzerland, 4031 |
Study Chair: | Beat Muller, MD | University Hospital, Basel, Switzerland |
Study ID Numbers: | PARTIS |
Study First Received: | December 21, 2004 |
Last Updated: | April 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00099840 |
Health Authority: | Switzerland: Swissmedic |
common cold pharyngitis tonsillitis rhinosinusitis tracheo-bronchitis |
otitis media acute exacerbations of asthma acute exacerbations of chronic pulmonary disease community acquired pneumonia |
Respiratory Tract Diseases Respiratory Tract Infections Common Cold Otitis Lung Diseases Otitis Media |
Asthma Tonsillitis Bronchitis Pharyngitis Pneumonia |
Communicable Diseases Infection |