Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03322670
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2017-09-25
Brief Title:
Description of Pneumococcal Pneumonia
Sponsor:
CNGE Conseil
Organization:
CNGE Conseil
Study Overview
Official Title:
Description of Pneumococcal Community-acquired Pneumonia in General Practice in France
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
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:
PneumoCAP
Brief Summary:
Statement of the problem
Overprescription of antibiotics raises important public health issues because of the emergence of multiresistant bacteria by selection pressure The results of the observational prospective study entitled CAPA on the description of 886 suspected cases of acute community-acquired pneumonia CAP treated in general practices in France confirm that whatever the etiologic hypothesis and the results of the chest X-ray these patients routinely receive antibiotics Therefore it is important to be able to distinguish cases of pneumococcal CAP in which early antibiotic treatment is justified from those cases for which another strategy could be considered
Primary objective
To identify the clinical biological and radiological characteristics of patients with pneumococcal CAP amongst all patients with CAP radiologically confirmed in general practice in France
Design
Prospective cross-sectional descriptive study
Inclusion criteria Adults older than 18 showing clinical signs suggestive of CAP at least one sign of infection and at least one pulmonary sign and able to realize chest X ray within 6 hours after prescription
Patient follow-up procedures Patients will be treated by standard of care according to French recommendations After observing clinical signs suggestive of CAP the physician prescribes a chest X-ray Then protocol-specific examinations blood sample oropharyngeal sample for multiplex polymerase chain reaction PCR sputum sample testing induced expectoration if possible urinary sample will be performed on all out patients Patients will be contacted again on day 28 to increase diagnostic certainty For patients with clinical signs of CAP and hospitalized the investigator will ask their consent to retrieve the hospital report on or before day 28 and to be contacted on day 90
Overprescription of antibiotics raises important public health issues because of the emergence of multiresistant bacteria by selection pressure The results of the observational prospective study entitled CAPA on the description of 886 suspected cases of acute community-acquired pneumonia CAP treated in general practices in France confirm that whatever the etiologic hypothesis and the results of the chest X-ray these patients routinely receive antibiotics Therefore it is important to be able to distinguish cases of pneumococcal CAP in which early antibiotic treatment is justified from those cases for which another strategy could be considered
Primary objective
To identify the clinical biological and radiological characteristics of patients with pneumococcal CAP amongst all patients with CAP radiologically confirmed in general practice in France
Design
Prospective cross-sectional descriptive study
Inclusion criteria Adults older than 18 showing clinical signs suggestive of CAP at least one sign of infection and at least one pulmonary sign and able to realize chest X ray within 6 hours after prescription
Patient follow-up procedures Patients will be treated by standard of care according to French recommendations After observing clinical signs suggestive of CAP the physician prescribes a chest X-ray Then protocol-specific examinations blood sample oropharyngeal sample for multiplex polymerase chain reaction PCR sputum sample testing induced expectoration if possible urinary sample will be performed on all out patients Patients will be contacted again on day 28 to increase diagnostic certainty For patients with clinical signs of CAP and hospitalized the investigator will ask their consent to retrieve the hospital report on or before day 28 and to be contacted on day 90
Detailed Description:
The aim of the study is to enroll approximately 2000 patients with CAP in total Approximately 1000 X-ray positive patients and 1000 X-ray negative patients will be enrolled over 18 months
Investigating GPs will identify patients with clinical signs suggestive of CAP at clinic visits
A chest X-ray will be prescribed in accordance with local standard of care practices for patients that do not require immediate hospitalization Chest X-ray must be completed within the 6 hours following its prescription
For the 1000 patients patient enrolment will be monitored centrally with a positive chest X-ray all procedures will be undertaken according to the protocol Patients will attend the local medical analysis laboratory for biological sample collection blood sputum oropharyngeal swab for the PCR and urine If a patient has taken antibiotics prior to the clinic visit at which CAP is suspected will only have urine samples collected
As a diagnostic confirmation of the chest X-ray assessments for the 1000 patients for whom the local radiologist will have diagnosed a parenchymal opacity compatible with CAP 200 patients will be randomly selected by the clinical research organization CRO Paris Descartes Necker Cochin A central independent thoracic radiologist expert will re-read their chest X-ray In case of insufficient agreement all chest X-rays will be re-read
Patients will be asked to complete and return a self-assessment questionnaire at day 7 D7 and at day 14 D14 on the number of work days missed if any interruption of occupational activity and the number of days of restricted everyday activities or recreational
Patients will be contacted by telephone at day 28 and day 90 if they are hospitalized between day 0 and day 28
For the 1000 patients patient enrolment will be monitored centrally with a negative chest X-ray no medical analysis will be performed Only clinical examination data will be recorded Patients will be contacted by telephone at day 28
For patients who will be directly hospitalized before the completion of the additional examinations they will be contacted by telephone at day 28 to retrieve the hospitalization report and at day 90
Control Patients will be included for the assessment of Pneumococcal urine antigen detection UAD Assay in the two weeks following the inclusion of a patient with CAP investigators should include a control patient according to the control patient inclusion exclusion criteria For these healthy patients the number of inclusion is limited to 400
Investigating GPs will identify patients with clinical signs suggestive of CAP at clinic visits
A chest X-ray will be prescribed in accordance with local standard of care practices for patients that do not require immediate hospitalization Chest X-ray must be completed within the 6 hours following its prescription
For the 1000 patients patient enrolment will be monitored centrally with a positive chest X-ray all procedures will be undertaken according to the protocol Patients will attend the local medical analysis laboratory for biological sample collection blood sputum oropharyngeal swab for the PCR and urine If a patient has taken antibiotics prior to the clinic visit at which CAP is suspected will only have urine samples collected
As a diagnostic confirmation of the chest X-ray assessments for the 1000 patients for whom the local radiologist will have diagnosed a parenchymal opacity compatible with CAP 200 patients will be randomly selected by the clinical research organization CRO Paris Descartes Necker Cochin A central independent thoracic radiologist expert will re-read their chest X-ray In case of insufficient agreement all chest X-rays will be re-read
Patients will be asked to complete and return a self-assessment questionnaire at day 7 D7 and at day 14 D14 on the number of work days missed if any interruption of occupational activity and the number of days of restricted everyday activities or recreational
Patients will be contacted by telephone at day 28 and day 90 if they are hospitalized between day 0 and day 28
For the 1000 patients patient enrolment will be monitored centrally with a negative chest X-ray no medical analysis will be performed Only clinical examination data will be recorded Patients will be contacted by telephone at day 28
For patients who will be directly hospitalized before the completion of the additional examinations they will be contacted by telephone at day 28 to retrieve the hospitalization report and at day 90
Control Patients will be included for the assessment of Pneumococcal urine antigen detection UAD Assay in the two weeks following the inclusion of a patient with CAP investigators should include a control patient according to the control patient inclusion exclusion criteria For these healthy patients the number of inclusion is limited to 400
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None