Description of Pneumococcal Pneumonia
Description of Pneumococcal Pneumonia
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.
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.
Inclusion Criteria:

 - 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 Criteria:

 -  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.