Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical protocol was developed for the management of adult outpatients with community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients are assigned to oral azithromycin or levofloxacin according to procalcitonin (PCT) levels measured with a rapid point-of-care method. When PCT levels are <0.5 ng/ml, azithromycin, 500 mg/day is given orally for 5 days; if PCT is ≥0.5 ng/ml, levofloxacin, 500 mg/day is given orally for 7 days

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Treatments: Azithromycin; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Fever with or without respiratory symptoms

• New infiltrate on chest radiograph

• Pneumonia Severity Index (PSI) score ≤ 70 (risk classes I and II).

Exclusion Criteria:

• PSI risk classes III-V

• Age ≥65 years

• Comorbidity (diabetes, chronic obstructive pulmonary disease, chronic renal disease, neoplasia, immunosuppression including HIV infection, chronic heart failure or cirrhosis)

• White blood cell count ≥20.0 x 109/L

• Pleural effusion

• Bilateral infiltrates

• Previous failure or allergy to macrolides or quinolones

• Need for oxygen therapy -