Procalcitonin Guided Antibiotic Use in Acute Respiratory Tract Infections (PARTI)-Study
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Purpose
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 |
|---|---|
|
Respiratory Tract Infections |
Procedure: Procalcitonin guided antibiotic therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Procalcitonin Guided Antibiotic Use in Acute Respiratory Tract Infections in Primary Care - A Randomized Controlled Trial |
- Days with restrictions from ARTI
- Rate of AB prescriptions
- days with AB use
- symptoms from ARTI
- relapse rate from ARTI within 28 days
- days with side effects from ABs and off work
- cost-effectiveness
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2004 |
| Study Completion Date: | April 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Switzerland | |
| University Hospital | |
| Basel, CH, Switzerland, 4031 | |
| Study Chair: | Beat Muller, MD | University Hospital, Basel, Switzerland |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00099840 History of Changes |
| Other Study ID Numbers: | PARTIS |
| Study First Received: | December 21, 2004 |
| Last Updated: | April 24, 2007 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
common cold pharyngitis tonsillitis rhinosinusitis tracheo-bronchitis |
otitis media acute exacerbations of asthma acute exacerbations of chronic pulmonary disease community acquired pneumonia |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Infection Respiratory Tract Diseases Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013