Status:
COMPLETED
Description of Pneumococcal Pneumonia
Lead Sponsor:
CNGE Conseil
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
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 observati...
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. Investiga...
Eligibility Criteria
Inclusion
- \- Inclusion criteria for suspected CAP population:
- Age ≥18 years
- Presence of at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization):
- at least one sign of infection
- fever \> 38.5°C (maximum temperature measured by the patient or GP)
- tachycardia \> 100 /min
- hyperpnea \> 20/min
- global impression of severity\*
- muscle aches, fatigue, or chills
- and at least one sign of pulmonary localization
- cough
- unilateral chest pain
- purulent or non-purulent sputum
- auscultatory abnormality compatible with CAP (focus of crackles)
- Affiliation with health insurance system
- Chest X-ray performed within 6 hours of presenting to the general practice
- Willing and capable of providing blood, oropharyngeal urine samples, and sputum sample, for filling self-administered questionnaires to D7 and D14 and to be contacted again on D28 and on D90 if necessary, if chest X-ray is positive.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Inclusion criteria for who do not wish to participate in the full study or who have not received a chest X-ray
- Age ≥18 years
- Presence of at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization):
- at least one sign of infection
- fever \> 38.5°C (maximum temperature measured by the patient or GP)
- tachycardia \> 100 /min
- hyperpnea \> 20/min
- global impression of severity\*
- muscle aches, fatigue, or chills
- and at least one sign of pulmonary localization
- cough
- unilateral chest pain
- purulent or non-purulent sputum
- auscultatory abnormality compatible with CAP (focus of crackles)
- Control Inclusion Criteria
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- A signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Age ≥18 years.
- Patients who are will to provide a urine sample
Exclusion
- Exclusion criteria for suspected CAP population:
- conditions of medical treatment not allowing for chest X-ray within 6 hours after diagnosis of CAP
- contraindication to chest X-ray
- conditions of medical management not allowing the realization of biological and bacteriological examinations within 8 hours of D0 consultation (except for patient immediately hospitalized)
- chest X-ray finding not compatible with CAP : chest X-ray showing another lung disease than a CAP (for example: pulmonary neoplasia, tuberculosis, pulmonary embolism)
- Control Exclusion Criteria
- Patients presenting with any of the following will not be included in the study:
- Patients who are investigational site staff members or relatives of those site staff member or subjects who are Pfizer employees directly involved in the conduct of the trial.
- Patients with suspicion of CAP or other respiratory infectious diseases, as well as evidence of or documented concomitant infectious disease.
- Patients residing in any long-term care facilities (for example, nursing homes, respite care facilities, etc).
- Patients with known bronchial obstruction or a history of post-obstructive pneumonia. Chronic obstructive pulmonary disease (COPD) is permissible, provided there has not been an exacerbation within the 3 months prior to enrollment.
- Patients with primary lung cancer or another malignancy metastatic to the lungs.
- Patients with fever (measured temperature of ≥38.0° C measured by a healthcare provider).
- Patients with significant immunosuppressive disease such as AIDS, leukemia, etc.
- Patients with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPV) administration within the past 30 days.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT03322670
Start Date
December 21 2017
End Date
January 3 2020
Last Update
February 12 2021
Active Locations (1)
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1
URC-CIC Paris Descartes-Cochin-Necker
Paris, France, 75006