Description of Pneumococcal Pneumonia (PneumoCAP)

February 11, 2021 updated by: GILBERG SERGE, CNGE Conseil

Description of Pneumococcal Community-acquired Pneumonia in General Practice in France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

412

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75006
        • URC-CIC Paris Descartes-Cochin-Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In France, patients who visit a General Practitioner and who have clinical signs suggestive of CAP at clinic visits.

For the control cohort, healthy patient who visit a General Practitioner in the two weeks following the inclusion of a patient with CAP confirmed on the chest X-ray

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Signs of CAP and a positive chest X-Ray
Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and a chest X-Ray not compatible with CAP
Other: Signs of CAP and a positive chest X-Ray
  • collection of clinical examination data
  • biological and bacteriological examinations (blood, urine, sputum, nasopharyngeal)
  • self-reported questionnaires on duration of symptoms and restriction of activity
  • telephone contact on day 28 and day 90 if hospitalized before day 28
Patients directly hospitalized
Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and who are directly hospitalized before complementary examinations
Other: Patients directly hospitalized
  • collection of clinical examination data
  • telephone contact on day 28 and retrieval of hospitalization report
  • telephone contact on day 90
Control patients
Healthy Patients (age-matched with a radiologically confirmed CAP patient)
Diagnostic test: Control patients
- bacteriological examinations (urine)
Patients with partial participation
Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and who can not or do not want to perform all the complementary examinations of the study
Other: Patients with partial participation
- collection of clinical examination data
Signs of CAP and a negative Chest X-Ray
Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and a chest X-Ray not compatible with CAP
Other: Signs of CAP and a negative chest X-Ray
  • collection of clinical examination data
  • telephone contact on day 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of pneumococcal CAP amongst the other etiological CAP with a positive chest X-ray
Time Frame: Day 0
Determination oh the proportion of pneumococcal CAP among all CAP radiologically confirmed with other etiologies identified, followed in general practice in France. Comparison of the clinical, biological and radiological characteristics of patients with radiologically confirmed pneumococcal CAP to those with radiologically confirmed CAP patients for whom another microbiological etiology was identified
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of clinical characteristics of patients treated in general practice for a radiologically confirmed CAP, based on the microbiological etiologies
Time Frame: Day 0
Number and percentage of each of the clinical characteristics according to the microbiological etiology according to the presence or not of a sepsis and according to an hospitalization or not
Day 0

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of biological characteristics of patients treated in general practice for a radiologically confirmed CAP, based on the microbiological etiologies
Time Frame: Day 0
Number and percentage of each of the biological characteristics according to the microbiological etiology according to the presence or not of a sepsis and according to an hospitalization or not
Day 0
Description radiological characteristics of patients treated in general practice for a radiologically confirmed CAP, based on all the microbiological etiologies.
Time Frame: day 0
Number and percentage of each of the radiological characteristics according to the microbiological etiology according to the presence or not of a sepsis and according to an hospitalization or not
day 0
Incidence rate of pneumococcal CAP radiologically confirmed on chest X-ray, in the general practitioners settings
Time Frame: Day 0
Number of adult patients with pneumococcal CAP and positive chest X-Ray and the number of adult patients with clinical signs of CAP (defined as 2 signs suggestive of CAP) in general practice
Day 0
Descriptive analysis of Streptococcus pneumoniae serotypes identified on the urine assays.
Time Frame: Day 0
Number of pneumonia according to each serotype of Streptococcus pneumoniae identified on the Urine Antigen Detection, among all pneumococcal CAP
Day 0
Descriptive analysis of Streptococcus pneumoniae serotypes identified on the blood culture
Time Frame: Day 0
Number of pneumonia according to each serotype of Streptococcus pneumoniae identified on the blood culture, among all pneumococcal CAP
Day 0
Descriptive analysis of Streptococcus pneumoniae serotypes identified on the sputum culture
Time Frame: Day 0
Number of pneumonia according to each serotype of Streptococcus pneumoniae identified on the sputum culture, among all pneumococcal CAP
Day 0
Assessment of costs generated by pneumococcal CAP managed in ambulatory setting.
Time Frame: Day 90
Costs of medical care (medical consultation, medicated treatment, hospitalization costs, work stoppage)
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CNGE Conseil

Investigators

  • Principal Investigator: Serge Gilberg, Professor, University Paris Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2017

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

January 3, 2020

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N° ID RCB : 2016-A01537-44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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