Description of Pneumococcal Pneumonia — PneumoCAP  

Community-acquired Pneumonia Clinical Trial

Official title: Description of Pneumococcal Community-acquired Pneumonia in General Practice in France

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

• NCT number: NCT03322670
• Study type: Observational
• Source: CNGE Conseil
• Status: Completed
• Start date: December 21, 2017
• Completion date: January 3, 2020