Ignite Creation Date:
2024-05-06 @ 7:47 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02600806
Status:
UNKNOWN
Last Update Posted:
2015-11-09
First Post:
2015-11-04
Brief Title:
Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients
Sponsor:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Organization:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study Overview
Official Title:
Evaluation of a Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 ngml azithromycin 500 mgday is given orally for 5 days if PCT is 05 ngml levofloxacin 500 mgday is given orally for 7 days
Detailed Description:
A clinical protocol was developed in collaboration with the hospitals 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 PCT05 ngml azithromycin 500 mgday orally for 5 days
2 PCT05ngml levofloxacin 500 mgday 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 05 ngml 05 ngml 2 ngml 10 ngml
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 SL 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
Treatment assignment
1 PCT05 ngml azithromycin 500 mgday orally for 5 days
2 PCT05ngml levofloxacin 500 mgday 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 05 ngml 05 ngml 2 ngml 10 ngml
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 SL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None