An observational study in Community-acquired Pneumonia, sponsored by CNGE Conseil. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by CNGE Conseil · Observational
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Among 40 studies in Community-Acquired Pneumonia with a site in France — 11 open to participants now, 11 under way, 5 of them phase 3. Community-Acquired Pneumonia · France.
Among the 40 studies in Community-Acquired Pneumonia with a site in France, this one is the 7th largest by enrollment of the 14 observational ones that give a count, is one of 2 that started in 2017, is one of 14 observational ones, and was the 15th registered.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
Browse Community-Acquired Pneumonia studies →11 of the 40 studies in Community-Acquired Pneumonia with a site in France are open now. Recruiting first, the newest first:
University Hospital, Caen · Sites in France
University Hospital, Tours · Sites in France
Ages 18+
Nantes University Hospital · Sites in France
Ages 65+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Biotest · Sites in France, United States, Argentina and 15 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 412 is below the median of 650 across 111 observational studies indexed under Community-Acquired Pneumonia.
Median enrollment 327 across the 26 interventional studies, 365 across the 14 observational. Of the 27 that completed or were terminated, 2 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 40 have an industry lead sponsor. The 10 most frequent:
CNGE Conseil is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
CNGE Conseil has 1 study filed under Community-Acquired Pneumonia — fewer than ten, so there is no comparison to draw.
4 of the studies in Community-Acquired Pneumonia with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05903352Phase 3Assistance Publique - Hôpitaux de ParisCustomized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia | 2027-05 |
| NCT06229288Phase 3Nantes University HospitalAmoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward | 2027-05-25 |
| NCT07070284Joan Sabater-RieraESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients | 2026-11-30 |
| NCT06291012University Hospital, MontpellierStopping Pneumonia Antibiotherapy Regimen Early | 2027-05-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 40 studies in Community-Acquired Pneumonia with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Inclusion Criteria:
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
and at least one sign of pulmonary localization
Evidence of a personally signed and dated document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
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
and at least one sign of pulmonary localization
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:
Exclusion criteria for suspected CAP population:
Patients presenting with any of the following will not be included in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Healthy Patients (age-matched with a radiologically confirmed CAP patient)
Diagnostic Test: Control patients
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
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 * 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
* collection of clinical examination data * telephone contact on day 28 and retrieval of hospitalization report * telephone contact on day 90
- bacteriological examinations (urine)
- collection of clinical examination data
* collection of clinical examination data * telephone contact on day 28
Percentage of pneumococcal CAP amongst the other etiological CAP with a positive chest X-ray
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
Time frame: Day 0
Description of clinical characteristics of patients treated in general practice for a radiologically confirmed CAP, based on the microbiological etiologies
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
Time frame: Day 0
Description of biological characteristics of patients treated in general practice for a radiologically confirmed CAP, based on the microbiological etiologies
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
Time frame: Day 0
Description radiological characteristics of patients treated in general practice for a radiologically confirmed CAP, based on all the microbiological etiologies.
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
Time frame: day 0
Incidence rate of pneumococcal CAP radiologically confirmed on chest X-ray, in the general practitioners settings
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
Time frame: Day 0
Descriptive analysis of Streptococcus pneumoniae serotypes identified on the urine assays.
Number of pneumonia according to each serotype of Streptococcus pneumoniae identified on the Urine Antigen Detection, among all pneumococcal CAP
Time frame: Day 0
Descriptive analysis of Streptococcus pneumoniae serotypes identified on the blood culture
Number of pneumonia according to each serotype of Streptococcus pneumoniae identified on the blood culture, among all pneumococcal CAP
Time frame: Day 0
Descriptive analysis of Streptococcus pneumoniae serotypes identified on the sputum culture
Number of pneumonia according to each serotype of Streptococcus pneumoniae identified on the sputum culture, among all pneumococcal CAP
Time frame: Day 0
Assessment of costs generated by pneumococcal CAP managed in ambulatory setting.
Costs of medical care (medical consultation, medicated treatment, hospitalization costs, work stoppage)
Time frame: Day 90
Ran from Dec 2017 to primary completion in Dec 2019, 23 months.
Of 38 observational studies under Community-Acquired Pneumonia, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →
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