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

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ClinicalTrials.gov Identifier: NCT02600806
Recruitment Status : Unknown
Verified November 2015 by Mar Masiá Canuto, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
Recruitment status was:  Recruiting
First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Mar Masiá Canuto, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Azithromycin Drug: Levofloxacin Phase 4

Detailed Description:

A clinical protocol was developed in collaboration with the hospital's Emergency Department for the management of adult outpatients with community-acquired pneumonia (CAP). Patients are assigned to 2 treatment categories according to the plasma procalcitonin (PCT) values.

Treatment assignment:

  1. PCT<0.5 ng/ml: azithromycin, 500 mg/day orally for 5 days
  2. PCT≥0.5ng/ml: levofloxacin, 500 mg/day orally for 7 days

Laboratory and microbiological studies:

In the ED, patients with signs and symptoms of pneumonia have a blood sample collected for routine biochemical and hematological determinations, and PCT concentration measurement.

Rapid testing for the determination of PCT are performed with BRAHMS PCT-Q, an immunochromatografic test for the semi-quantitative detection of PCT in serum (BRAHMS GmbH, 16761 Hennigsdorf, Germany). PCT concentration ranges are the following: <0.5 ng/ml; ≥ 0.5 ng/ml; ≥2 ng/ml; ≥10 ng/ml.

The etiological diagnostic workup includes obtaining sputum samples from patients with productive cough, and a urine sample for detection of S. pneumoniae and Legionella pneumophila serogroup 1 antigens by immunochromatographic assays (Binax NOW, Alere Healthcare SLU, Spain). Only qualified sputum samples, as defined according to standard criteria (presence of >25 WBC and <10 squamous cells per low-power magnification field [x10]) are evaluated. Serum samples (obtained during the acute stage of illness and 4 weeks later) are collected and frozen at -80ºC for ulterior serological testing. An indirect chemiluminescent immunoassay (VirClia® Monotest, Vircell, S.L., Granada, Spain) is performed to detect IgG antibodies against Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila and Coxiella burnetii. Calculation of cutoff values and interpretation of the results are performed in accordance with the instructions of the manufacturer. The diagnostic criteria are either a seroconversion (index value from negative to positive) or a significant increase in the index value (≥threefold) in paired samples. All assays are performed and analyzed blindly by the same person.

Follow-up and outcome measures:

After treatment has been assigned, patients are referred to the outpatients clinic, where they are seen within the following 24 hours (Visit 2). A phone visit (Visit 3) is scheduled on day 7, and the last programmed visit on day 30 at the clinic (Visit 4). Patients are instructed to visit the outpatients' clinic if their clinical status worsens or fever persists more than 48 hours after the first visit. Cure is defined as an improvement or lack of progression of baseline radiographic findings at the end of therapy (EOT) and resolution of signs, including chest X-Ray, and symptoms of pneumonia at visit 4. Failure is defined as persistence or progression of signs and symptoms or progression of radiological signs of pneumonia at EOT, persistent infiltrate on X-Ray at visit 4, and initiation within 2 calendar days of the initial antibiotic therapy of a different potentially effective antibiotic, death on or after day 3 attributable to primary infection, or relapsed infection at visit 4. Antibiotic change requirement due to toxicity, and need for hospital admission is also recorded.

In addition to the short-term outcome, the long-term (3-year) outcome of the patients is assessed through a structured telephone interview.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients
Study Start Date : May 2005
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016


Arm Intervention/treatment
Azithromycin/levofloxacin
Azithromycin or levofloxacin are given according to serum procalcitonin levels
Drug: Azithromycin
Patients are given oral azithromycin when procalcitonin levels are < 0.5 ng/ml
Other Name: Zithromax, Zmax

Drug: Levofloxacin
Patients are given oral levofloxacin when procalcitonin levels are >= 0.5 ng/ml.
Other Name: Tavanic, Levaquin




Primary Outcome Measures :
  1. Clinical cure [ Time Frame: 30-day ]
    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


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by a specific questionnaire designed for the study [ Time Frame: 30-day ]
  2. Mortality [ Time Frame: Through study completion, an average of 3 years ]
    30-day and during the following 3 years or longer

  3. Recurrences [ Time Frame: Through study completion, an average of 3 years ]
    New episodes of community-acquired pneumonia ocurring after clinical cure of the initial episode



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600806


Contacts
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Contact: Mar Masiá, MD +34966616754 marmasiac@gmail.com
Contact: Inmaculada Revert +34 966 61 61 74 ceic_elx@gva.es

Locations
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Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 93293
Contact: Mar Masiá, MD    +34966616754    marmasiac@gmail.com   
Sponsors and Collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Investigators
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Principal Investigator: Mar Masiá, MD Unidad Enfermedades Infecciosas, Hospital General Univeristario de Elche
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mar Masiá Canuto, MD, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT02600806    
Other Study ID Numbers: Pi QA-2004-35
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015
Keywords provided by Mar Masiá Canuto, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:
Community-acquired pneumonia
Procalcitonin
Outpatients
Outcomes
Azithromycin
Fluoroquinolones
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors