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

NCT02600806 | Unknown Phase 4 DMC

• 1 other identifier: Pi QA-2004-35
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumonia; Procalcitonin; Outpatients; Outcomes; Azithromycin; Fluoroquinolones

Outcome Measures

Primary Outcomes (1)

• Clinical cure

  Improvement or lack of progression of baseline radiographic findings at the end of therapy and resolution of signs, including chest X-Ray, and symptoms of pneumonia

  30-day

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by a specific questionnaire designed for the study

  30-day

• Mortality

  Through study completion, an average of 3 years

• Recurrences

  Through study completion, an average of 3 years

Study Arms (1)

Azithromycin/levofloxacin

OTHER

Azithromycin or levofloxacin are given according to serum procalcitonin levels

Drug: Azithromycin; Drug: Levofloxacin

Interventions

Azithromycin DRUG

Patients are given oral azithromycin when procalcitonin levels are \< 0.5 ng/ml

Also known as: Zithromax, Zmax

Azithromycin/levofloxacin

Levofloxacin DRUG

Patients are given oral levofloxacin when procalcitonin levels are \>= 0.5 ng/ml.

Also known as: Tavanic, Levaquin

Azithromycin/levofloxacin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fever with or without respiratory symptoms
• New infiltrate on chest radiograph
• Pneumonia Severity Index (PSI) score ≤ 70 (risk classes I and II).

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 93293, Spain

RECRUITING

Related Publications (4)

• Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax. 2012 Jan;67(1):71-9. doi: 10.1136/thx.2009.129502. Epub 2010 Aug 20.

  PMID: 20729232 RESULT

• Masia M, Gutierrez F, Shum C, Padilla S, Navarro JC, Flores E, Hernandez I. Usefulness of procalcitonin levels in community-acquired pneumonia according to the patients outcome research team pneumonia severity index. Chest. 2005 Oct;128(4):2223-9. doi: 10.1378/chest.128.4.2223.

  PMID: 16236878 RESULT

• File TM Jr, Marrie TJ. Does empiric therapy for atypical pathogens improve outcomes for patients with CAP? Infect Dis Clin North Am. 2013 Mar;27(1):99-114. doi: 10.1016/j.idc.2012.11.005.

  PMID: 23398868 RESULT

• Masia M, Padilla S, Ortiz de la Tabla V, Gonzalez M, Bas C, Gutierrez F. Procalcitonin for selecting the antibiotic regimen in outpatients with low-risk community-acquired pneumonia using a rapid point-of-care testing: A single-arm clinical trial. PLoS One. 2017 Apr 20;12(4):e0175634. doi: 10.1371/journal.pone.0175634. eCollection 2017.

  PMID: 28426811 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Azithromycin; Levofloxacin; Ofloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mar Masiá, MD

  Unidad Enfermedades Infecciosas, Hospital General Univeristario de Elche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mar Masiá, MD

CONTACT

+34966616754; marmasiac@gmail.com

Inmaculada Revert

CONTACT

+34 966 61 61 74; ceic_elx@gva.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 9, 2015
• Study Start: May 1, 2005
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 9, 2015

Record last verified: 2015-11

Locations

ES (1)