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

NCT00099840 | Completed

• 1 other identifier: PARTIS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

common cold; pharyngitis; tonsillitis; rhinosinusitis; tracheo-bronchitis; otitis media; acute exacerbations of asthma; acute exacerbations of chronic pulmonary disease; community acquired pneumonia

Outcome Measures

Primary Outcomes (1)

• Days with restrictions from ARTI

Secondary Outcomes (6)

• 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

Interventions

Procalcitonin guided antibiotic therapy PROCEDURE

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Basel Institute of Clinical Epidemiology (BICE): collaborator
• Brahms AG: collaborator

Study Sites (1)

University Hospital

Basel, CH, 4031, Switzerland

Location

Related Publications (1)

• Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.

  PMID: 14987884 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold; Pharyngitis; Tonsillitis; Rhinosinusitis; Otitis Media; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Rhinitis; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Otitis; Ear Diseases; Community-Acquired Infections; Pneumonia

Study Officials

• Beat Muller, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2004
• First Posted: December 21, 2004
• Study Start: December 1, 2004
• Study Completion: April 1, 2006
• Last Updated: April 25, 2007

Record last verified: 2006-01

Locations

CH (1)